Lediga jobb Takara Bio Europe AB i Göteborg

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Senior Accountant at Takara Bio Europe Swedish Filial

Takara Bio Europe Swedish Filial, a branch of Takara Bio Europe in France and a part of the Takara Bio group, is located in Göteborg, Sweden. The company has long-standing experience in stem cells. For more information, visit our website: www.takarabio.com. The Takara Bio Group possesses broad expertise in molecular biology tools business and is a worldwide supplier that has been developing and marketing various kinds of molecular biology tools, including ... Visa mer
Takara Bio Europe Swedish Filial, a branch of Takara Bio Europe in France and a part of the Takara Bio group, is located in Göteborg, Sweden. The company has long-standing experience in stem cells. For more information, visit our website: www.takarabio.com.
The Takara Bio Group possesses broad expertise in molecular biology tools business and is a worldwide supplier that has been developing and marketing various kinds of molecular biology tools, including enzymes and kits for PCR (polymerase chain reaction) and NGS (next generation sequencing), since 1979.
Description
The Senior accountant will be responsible for establishing a financial reporting to the European headquarter in France, controlling Swedish branch’s accounting activities by developing and implementing process for collecting, analyzing, verifying and reporting accounting information.
Collaborate closely with the Senior finance manager in France for different cost analysis and preparation of financial reporting and budget to group and ensure the new ERP system. The Accounting Manager will also involve as a supporting role of company’s general administration, including internal controls and human resource related tasks.
Position Title: Senior Accountant
Department : Accounting and Administration
Reports to: Senior finance manager in France
Seniority Level: Mid-level


?Primary Duties & Responsibilities
· Supplier invoice validation;
· Control of cash flow and update the forecast;
· Control of accounts payable and receivable;
· Weekly supplier payment verification;
· Supervise accountant’s task;
· Verify payroll and social declaration;
· ERP improvements and corrections;
· Prepare Tax declarations (VAT / Social charges);
· Apply our monthly accounting control procedures;
· Prepare accrual costs and revenues list for the closing;
· Verify royalty calculation;
· Stock calculation for the monthly end closing;
· Cost allocation calculations;
· Collaborate with production team for miscellaneous issues which impacts on Financial result;
· Production time reporting project setting;
· Establish financial reports every month to be sent to European headquarter in France with respecting the deadline;
· Prepare the elements for consolidation and collaborate with Senior finance manager in France;
· Assistance for analyzing costs for the production (Inventory value, allocation of indirect costs, etc);
· Financial result presentation to staff meeting;
· Ensure the preparation of budgets, their monthly follow-up, as well as the quarterly and year-end forecasts;
· Perform analytical determinations of people hours, consumables and fixed costs for the cost of goods;
· Organize our internal controls and audits;
· Coordinate our external audits;
· Administrative tasks (Insurances; Alarm, ets)

Qualifications
To fit in the role as a Senior Accountant, you need to have a bachelor’s degree in accounting or finance. Furthermore, you have three to five years of experience from accounting or a similar role. The strong communication skills and fluent in both Swedish and English are required.
If you have experience from working in an international company, it is seen as relevant for the position.
General Duties & Responsibilities
· Works on problems of diverse scope where analyses of data require evaluation of identifiable factors.
· Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
· Networks with senior internal and external personnel in own area of expertise.
· Meeting the reporting deadline. Visa mindre

Quality Control Manager GMP

Ansök    Jul 31    Takara Bio Europe AB    Laborant, biologi
Takara Bio Europe Swedish Filial (TBESF) located in Gothenburg, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem ce... Visa mer
Takara Bio Europe Swedish Filial (TBESF) located in Gothenburg, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including hiPSC, hESC and related media. Takara Bio Europe has an established GMP laboratory for production of pluripotent stem cell lines and related media. For more information, visit our website: www.takarabio.com
To better support our GMP activities we are leveraging our Quality Control unit and adding QC capabilities for GMP products. We are looking for a Quality Control Manager GMP who will strengthen our team in the GMP QC area. We are currently setting up the facility and equipment’s, and you will continue this work to finalise the processes and procedures for the first assays. Once the first assays are established, you will work hands on in the lab together with QC colleagues. Compliance of the GMP QC lab and its processes along with implementation of any new assay will be your responsibilities. You will also manage our external GMP QC labs supplying us with the services not yet inhouse.
The person we are looking for is well experienced in bioanalytical methods like flow cytometry and PCR, have transferred and validated methods in the area and is familiar with cell culture. Communication skills are crucial as there will be many contacts with suppliers of equipment as well as of external QC services. This role requires good knowledge and adherence to Quality principles and standards, including pharmacopoeia methods. You will be part of the quality team and initially report to the Associate Director Quality.

Work description
Project phase:
Drive the implementation of GMP QC assays at the site
Set up agreements with QC suppliers for external services
Ensure the equipment is qualified and the methods are validated
Set up processes for and create SOPs


Operational phase:
Lead the daily work in the GMP QC lab
Hands on work in the GMP QC lab
Keep the GMP QC lab, its processes and SOPs in compliance
Maintain good relations with and evaluate QC service suppliers
Implement new GMP QC assays and when required, sourcing of equipment
Manage change controls and deviations and other quality processes in the GMP QC lab
Host and support audits and inspections


Matching candidate:
At least Masters Degree in Molecular Biology, Cell Biology or similar field
Hands-on experience of work in the wet lab (at least FC and PCR)
Broad knowledge in Quality principles and pharmacopoeia methods
Experience of assay development and validation, preferably in GMP or ISO17025 certified lab
Analytical mindset and troubleshooting skills
Mammalian cell culture experience is an advantage
Experience of work with ATMP products is an advantage
Good communication skills


You will be an important part of our new area of GMP QC both during the implementation and later during the operational phase. There will be a variety of tasks including hands on work in the lab as well as setting processes and writing SOPs, therefore the ability to work independently is required. At the same time you are the main contact for our external QC suppliers requiring communication and cooperation skills. The Takara office in Gothenburg can offer you a familiar environment where each person is doing a difference. Our official language is English.

Welcome with your application no later than August 31, 2023. We will start the evaluation of candidates in mid-August.

For more information please contact [email protected],
phone +46 765 25 09 61 Visa mindre

Quality Control Manager GMP

Ansök    Jul 31    Takara Bio Europe AB    Molekylärbiolog
Takara Bio Europe Swedish Filial (TBESF) located in Gothenburg, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem ce... Visa mer
Takara Bio Europe Swedish Filial (TBESF) located in Gothenburg, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including hiPSC, hESC and related media. Takara Bio Europe has an established GMP laboratory for production of pluripotent stem cell lines and related media. For more information, visit our website: www.takarabio.com
To better support our GMP activities we are leveraging our Quality Control unit and adding QC capabilities for GMP products. We are looking for a Quality Control Manager GMP who will strengthen our team in the GMP QC area. We are currently setting up the facility and equipment’s, and you will continue this work to finalise the processes and procedures for the first assays. Once the first assays are established, you will work hands on in the lab together with QC colleagues. Compliance of the GMP QC lab and its processes along with implementation of any new assay will be your responsibilities. You will also manage our external GMP QC labs supplying us with the services not yet inhouse.
The person we are looking for is well experienced in bioanalytical methods like flow cytometry and PCR, have transferred and validated methods in the area and is familiar with cell culture. Communication skills are crucial as there will be many contacts with suppliers of equipment as well as of external QC services. This role requires good knowledge and adherence to Quality principles and standards, including pharmacopoeia methods. You will be part of the quality team and initially report to the Associate Director Quality.

Work description
Project phase:
Drive the implementation of GMP QC assays at the site
Set up agreements with QC suppliers for external services
Ensure the equipment is qualified and the methods are validated
Set up processes for and create SOPs


Operational phase:
Lead the daily work in the GMP QC lab
Hands on work in the GMP QC lab
Keep the GMP QC lab, its processes and SOPs in compliance
Maintain good relations with and evaluate QC service suppliers
Implement new GMP QC assays and when required, sourcing of equipment
Manage change controls and deviations and other quality processes in the GMP QC lab
Host and support audits and inspections


Matching candidate:
At least Masters Degree in Molecular Biology, Cell Biology or similar field
Hands-on experience of work in the wet lab (at least FC and PCR)
Broad knowledge in Quality principles and pharmacopoeia methods
Experience of assay development and validation, preferably in GMP or ISO17025 certified lab
Analytical mindset and troubleshooting skills
Mammalian cell culture experience is an advantage
Experience of work with ATMP products is an advantage
Good communication skills


You will be an important part of our new area of GMP QC both during the implementation and later during the operational phase. There will be a variety of tasks including hands on work in the lab as well as setting processes and writing SOPs, therefore the ability to work independently is required. At the same time you are the main contact for our external QC suppliers requiring communication and cooperation skills. The Takara office in Gothenburg can offer you a familiar environment where each person is doing a difference. Our official language is English.

Welcome with your application no later than August 31, 2023. We will start the evaluation of candidates in mid-August.

For more information please contact [email protected],
phone +46 765 25 09 61 Visa mindre

QA Associate Molecular Biology Tools

Quality Assurance Associate Takara Bio Europe Swedish Filial (TBESF) located in Gothenburg, is part of the Takara Bio Group. The Group possesses broad expertise in molecular biology tools and is a worldwide supplier that has been developing and marketing various kinds of products since 1979. This includes enzymes and kits for PCR (polymerase chain reaction) and NGS (next generation sequencing). Recently, the Takara Bio Group added IVD (in vitro diagnostic)... Visa mer
Quality Assurance Associate
Takara Bio Europe Swedish Filial (TBESF) located in Gothenburg, is part of the Takara Bio Group. The Group possesses broad expertise in molecular biology tools and is a worldwide supplier that has been developing and marketing various kinds of products since 1979. This includes enzymes and kits for PCR (polymerase chain reaction) and NGS (next generation sequencing). Recently, the Takara Bio Group added IVD (in vitro diagnostic) kits using PCR technology to its portfolio.
To strengthen our ability to support our customer needs Europe, TBESF will expand its operations into molecular biology tools and we are now looking for a QA associate to join our team. You will work closely together with our project manager to prepare our facility and management system for the implementation of molecular biology tools assembly at the site. The long-term goal is an 13485-certified manufacturing site with QC capabilities to support our European customers. In the near future we will contribute with ISO 9001 products assembled according to customer needs.
We are looking for a person with high quality focus experienced in the MDR and/or IVDR area. Preferably you have been working with both implementation projects for manufacturing as well as quality assurance in general within medtech. You feel confident in your quality role and understand the importance of being pragmatic but within the boundaries. You will be part of the quality team and report to the Associate Director Quality.
Work description
Project phase:
Drive the quality agenda during the implementation phase
Transfer of quality information from affiliate sites
Update our current QMS to support our molecular diagnostics business (initially ISO9001, long term ISO13485)

Operation phase:
Management of quality related issues
Manage change controls and deviations and other processes supporting the production
Review of documentation
Manage, evaluate and qualify suppliers
QMS administration
Support customer requests
Host and/or support audits


Matching candidate
Master’s Degree in relevant area
Work experience within quality for medical device and/or IVD (ISO13485/MDR/IVDR)
Participated in QMS implementation and/or update and/or administration
Experience of supplier management
Strong quality agenda
Auditor and experience of hosting audits

You will be an important part of the sites new offer within molecular biology. There will be a variety of tasks and the ability to work independently is required. We can offer you a familiar environment where each person is doing a difference.

Welcome with your application no later than April 23, 2023 by email to [email protected], subject QA Mol Biol.
We will start the evaluation of candidates as they arrive, and the position can be filled before due date.
For more information please contact [email protected], phone +46 765 25 09 61 Visa mindre

Accounting Manager

Takara Bio Europe Swedish Filial, a branch of Takara Bio Europe in France and a part of the Takara Bio group, is located in Göteborg, Sweden. The company has long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functional human cells (For more information, visit our website: www.takarabio.com). The Takara Bio Group possesses broad expertise in molecular biology tools business and is a worldwide s... Visa mer
Takara Bio Europe Swedish Filial, a branch of Takara Bio Europe in France and a part of the Takara Bio group, is located in Göteborg, Sweden. The company has long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functional human cells (For more information, visit our website: www.takarabio.com).
The Takara Bio Group possesses broad expertise in molecular biology tools business and is a worldwide supplier that has been developing and marketing various kinds of molecular biology tools, including enzymes and kits for PCR (polymerase chain reaction) and NGS (next generation sequencing), since 1979.


Description
The Accouting Manager will be responsible for for establishing a financial reporting to the Européan headquarter in France, controlling Swedish branch’s accounting activities by developing and implementing process for collecting, analyzing, veryfing and reporting accounting information.
Corraborate closely with the Senior finance manager in France for different cost analysis and preparation of financial reportings and budget to group. The Accounting Manager will also involve as a supporting role of company’s general administration, including internal controls and human resource related tasks.


Primary Duties & Responsibilities


Establish financial reports every month to be sent to Européen headquarter in France with respecting the deadline;
Apply our monthly accounting control procedures;
Cost analysis for the production (Inventory value, allocation of indirect costs, etc);
Supervise Accounting Associates in the department;
Ensure the preparation of budgets, their monthly follow-up, as well as the quarterly and year-end forecasts;
Perform analytical determinations of people hours, consumables and fixed costs for the cost of goods;
Prepare Tax declarations (income declaration / VAT / Social charges);
Manage our cash-flow;
Organize our internal controls and audits;
Coordinate our external audits and prepare Annual Report
Coordinate with the bank
Organiza payroll;
Administrative tasks ( Insurances / Purchase of PC / Office matters)
Back-up for



General Duties & Responsibilities
Works on problems of diverse scope where analyses of data require evaluation of identifiable factors.
Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Networks with senior internal and external personnel in own area of expertise.
Meeting the reporting deadline.



Education Requirement (minimum)
BA or BS Degree in Accounting


Experience Requirement (minimum)
Minimum 5 years related experiences working in Swedish SME, preferably in an international environment and production company as well;
Swedish Accounting Standard K3;
Swedish and English languages;
You are familiar with ERP software, IT tools, and advanced Excel functions; Visa mindre

QA Associate Molecular Biology Tools

Quality Assurance Associate Takara Bio Europe Swedish Filial (TBESF) located in Gothenburg, is part of the Takara Bio Group. The Group possesses broad expertise in molecular biology tools and is a worldwide supplier that has been developing and marketing various kinds of molecular biology tools since 1979. This includes enzymes and kits for PCR (polymerase chain reaction) and NGS (next generation sequencing). Recently, the Takara Bio Group added IVD (in vi... Visa mer
Quality Assurance Associate
Takara Bio Europe Swedish Filial (TBESF) located in Gothenburg, is part of the Takara Bio Group. The Group possesses broad expertise in molecular biology tools and is a worldwide supplier that has been developing and marketing various kinds of molecular biology tools since 1979. This includes enzymes and kits for PCR (polymerase chain reaction) and NGS (next generation sequencing). Recently, the Takara Bio Group added IVD (in vitro diagnostic) kits using PCR technology to its portfolio.
To strengthen our ability to support our customer needs in the European market, TBESF will expand its operations into molecular biology tools and we are now looking for a QA associate to join our team. You will work closely together with our project manager to prepare our facility and management system for the implementation of molecular biology tools production at the site. The long-term goal is an 13485-certified manufacturing site with QC capabilities to support our European customers. In the near future we will contribute with ISO 9001 molecular biology tool products assembled according to customer needs.
We are looking for a person with quality focus experienced in the MDR and/or IVDR area. Preferably you have been working with both implementation projects for manufacturing as well as quality assurance in general within medtech. You feel confident in your quality role and understand the importance of being pragmatic but within the boundaries. You will be part of the quality team and report to the Associate Director Quality.
Work description
Project phase:
Drive the quality agenda during the implementation of molecular biology tools at the site
Update our current QMS with adaptions to support our molecular diagnostics business (initially ISO9001, long term ISO13485)

Operation phase:
Manage QMS
Manage change controls and deviations and other processes supporting the production and monitoring trends
Manage, evaluate and qualify suppliers
Host/support audits


Matching candidate
Master’s Degree in relevant area
Work experience within quality for medical device and/or IVD (ISO13485/MDR/IVDR)
Participated in QMS implementation and/or update and/or administration
Experience of supplier management
Strong quality agenda
Auditor and experience of hosting audits

You will be an important part of our new offer within molecular biology during the implementation and in later operation. There will be a variety of tasks and the ability to work independently is required. We can offer you a familiar environment where each person is doing a difference.

Welcome with your application no later than March 22, 2023 by applying through https://www.welcometothejungle.com/en/companies/takara-bio/jobs/qa-associate-molecular-biology_goteborg
We will start the evaluation of candidates as they arrive, and the position can be filled before due date.
For more information please contact [email protected], phone +46 765 25 09 61 Visa mindre

Molecular Biology Tool Manager

Ansök    Dec 29    Takara Bio Europe AB    Molekylärbiolog
Takara Bio Europe AB/Swedish Filial, part of the Takara Bio group, is located in Göteborg, Sweden. The company has long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functional human cells (For more information, visit our website: www.takarabio.com). The Takara Bio Group possesses broad expertise in molecular biology tools business and is a worldwide supplier that has been developing and market... Visa mer
Takara Bio Europe AB/Swedish Filial, part of the Takara Bio group, is located in Göteborg, Sweden. The company has long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functional human cells (For more information, visit our website: www.takarabio.com).
The Takara Bio Group possesses broad expertise in molecular biology tools business and is a worldwide supplier that has been developing and marketing various kinds of molecular biology tools, including enzymes and kits for PCR (polymerase chain reaction) and NGS (next generation sequencing), since 1979. Recently, the Takara Bio Group added IVD (in vitro diagnostic) kits using PCR technology to its portfolio.
To grow the molecular biology tool business further in the European market, Takara Bio Europe AB/Swedish Filial will expand its operations into molecular biology tools and is now looking for a Molecular Biology Tool Manager to join our new Molecular Biology Tool team. You will be working with various tasks including manufacturing and supply chain management related to custom and OEM (original equipment manufacturer) products, including IVD kits based on molecular biology techniques. This position reports to the Director of Product & Service Development.
Primary Duties and Responsibilities
Direct transactions with Affiliate production sites
· Develop the transactions process directly with Affiliate production sites for custom and OEM products related to molecular biology tools by taking over the existing transaction process from Takara Bio Inc (TBI).
· Prepare SOPs required for the transaction process directly with Affiliate production sites for custom and OEM products related to molecular biology tools.
· Act as a supply chain manager for the transaction process for custom and OEM products related to molecular biology tools directly with Affiliate production sites.
Molecular biology tools production
· Plan and set up new facilities required for manufacturing of molecular biology tools.
· Prepare QC and manufacturing SOPs required for the transaction process directly with Affiliate production sites for custom and OEM products related to molecular biology tools.
· Act as a laboratory manager for the facilities required for manufacturing of molecular biology tools.
· Plan and execute molecular biology tools production work according to incoming job orders.
For both the direct transactions and the molecular biology tools production
· Work in close collaboration with Business Development in France and QC/QA team in Sweden.
· Maintain cost efficient operations (order/production size, sources used).
· Be responsible for new implementations as well as training of staff.
· Be responsible for reporting deviations and change controls.


General tasks and responsibilities:
· Scheduled work performed during weekends may be a requirement from time to time.
· Extended working hours will occur.
· Accurate documentation and data compilation
· Comply with quality standards, such as ISO9001 and ISO13485.
· Additional duties as assigned


We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated and skilled colleagues with whom you can both laugh and work.
You are welcome to submit your application no later than Jan 25th, 2023. Please note that we will have an ongoing review of candidates.

To apply for the position, please visit:
https://www.welcometothejungle.com/en/companies/takara-bio/jobs/molecular-biology-tool-manager_goteborg
You can find out more about Takara Bio at https://www.takarabio.com
Life in Gothenburg: https/www.movetogothenburg.com Visa mindre

QA/QC Associate Molecular Biology

QA/QC at Takara Bio Europe Swedish Filial Takara Bio Europe Swedish Filial (TBESF) located in Gothenburg, is part of the Takara Bio Group. The Group possesses broad expertise in molecular biology tools and is a worldwide supplier that has been developing and marketing various kinds of molecular biology tools since 1979. This includes enzymes and kits for PCR (polymerase chain reaction) and NGS (next generation sequencing). Recently, the Takara Bio Group ad... Visa mer
QA/QC at Takara Bio Europe Swedish Filial
Takara Bio Europe Swedish Filial (TBESF) located in Gothenburg, is part of the Takara Bio Group. The Group possesses broad expertise in molecular biology tools and is a worldwide supplier that has been developing and marketing various kinds of molecular biology tools since 1979. This includes enzymes and kits for PCR (polymerase chain reaction) and NGS (next generation sequencing). Recently, the Takara Bio Group added IVD (in vitro diagnostic) kits using PCR technology to its portfolio.
To strengthen our ability to support our customer needs in the European market, TBESF will expand its operations into molecular biology tools and we are now looking for a QA/QC associate to join our team. You will work closely together with our project manager to prepare our facility and management system for the implementation of molecular biology tools production at the site. The long-term goal is an ISO13485-certified manufacturing site with QC capabilities to support our European customers. In the near future we will contribute with ISO 9001 molecular biology tool products assembled according to customer needs.
We are looking for a person with quality focus experienced in the MDR and/or IVDR area. Preferably you have been working with both implementation projects for manufacturing as well as quality assurance and quality control including environmental monitoring, within medtech. You feel confident in your quality role and understand the importance of being pragmatic but within the boundaries. You will be part of the quality team and report to the Associate Director Quality


Work description
Project phase:
· Drive the quality agenda during the implementation of molecular biology tools at the site
· Update our current QMS with adaptions to support our molecular diagnostics business (initially ISO9001, long term 13485)
· Implementation of QC equipment and methods (PCR) to support the production
· Implementation of environmental and personal monitoring (EM/PM) for the clean rooms
Operations phase:
· Manage QMS
· Perform EM/PM for clean rooms
· Perform QC tests (including PCR) on manufactured products
· Manage change controls and deviations and other processes supporting the production and monitoring trends
· Release of raw materials
· Manage, evaluate and qualify suppliers
· Host/support audits

Matching candidate:
· Masters Degree in relevant area
· Work experience within quality for medical device and/or IVD (ISO13485/MDR/IVDR)
· Hands on experience of working with PCR and/or EM/PM
· Participated in QMS implementation and/or update and/or administration
· Experience of supplier management
· Strong quality agenda
· Auditor and experience of hosting audits


You will be an important part of our new offer within molecular biology during the implementation and in later operation. There will be a variety of tasks including hands on tasks in the lab and clean room and the ability to work independently is required. We can offer you a familiar environment where each person is doing a difference.
Welcome with your application no later than March 31, 2023. We will start the evaluation of candidates as they arrive, and the position can be filled before due date.

For more information please contact [email protected]
phone +46 765 25 09 61 Visa mindre

Procurement Associate

Ansök    Dec 12    Takara Bio Europe AB    Inköpsassistent
Takara Bio Europe AB/Swedish Filial, formerly Cellartis AB, is focusing on culture media and stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluri... Visa mer
Takara Bio Europe AB/Swedish Filial, formerly Cellartis AB, is focusing on culture media and stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC, and related media Takara Bio Europe AB/Swedish Filial is located in state-of-the-art facilities in Göteborg, Sweden and has a newly established GMP laboratory for production of pluripotent stem cell lines and culture media. For more information, visit our website: www.takarabio.com.
Takara Bio Europe is now looking for a Procurement Associate joining our Supply Chain team to oversee purchasing activities and ensure that purchased items are obtained in a cost-efficient way and of high quality. As a part of our team, you will be working with various tasks including sourcing suitable goods and services, negotiating prices and terms, making purchases, tracking when supplies are received and maintaining records. Takara Bio Europe is working under quality standards (such as cGMP), and you will also work with qualification of certain suppliers and goods/services according to quality guidelines.
This position reports to the Associate Director Supply Chain Management.

Primary Duties & Responsibilities
Making purchases according to needs mainly from manufacturing department
Secure supply of goods for manufacturing department and others
Sourcing new goods and onboarding of new suppliers
Price and contract negotiation
Internal communication of needs and stock levels
Control and management of inventory including monthly reports to Finance
Track inbound deliveries
Qualification of certain material and suppliers
Maintain a good relationship with suppliers through close communication and collaboration
Supplier audits
Support development of supplier qualification procedures
Maintain accurate purchase and pricing records
Follow company Quality Management System processes and procedures; ISO 9001/2015 and cGMP
Act as purchasing contact person.
Support and liaise with logistics


General Duties & Responsibilities
Perform routine work independently, new tasks added after training.
Rely on instructions and pre-established guidelines when executing tasks.
Maintain knowledge of Regulatory guidelines and Quality principles such as ISO 9001/2015.
Other required duties may be assigned.


Education/Experience Requirement
Associate’s or Bachelor’s degree in Procurement or related field.
1-3 years relevant job experience in related field.
Knowledge about applicable regulatory framework.
Flexible and capable of handling multiple tasks
Proficiency in Microsoft office and specifically Excel
Good command of the English language in speaking and writing



We want you to be able to act with high accuracy in a rapid and flexible manner, that you enjoy having a variety of different tasks and can work hands-on when needed. We offer you a familiar and dynamic environment where each person in the team makes a difference.
Position
Procurement Associate, full time, permanent position
Welcome with your application no later than January 8th, 2022. We apply continuous evaluation of applicants; therefore, this position can be filled before due date.
To apply for the position, please visit:
https://www.welcometothejungle.com/en/companies/takara-bio/jobs/procurement-associate_goteborg Visa mindre

Product Manager, Stem Cells

About Takara Bio: Takara Bio is a world leader in biotechnology research and development, offering a host of life science research solutions, from enzymes and GMP-grade reagents to contracted cell and gene therapy manufacturing services and is the developer of the RetroNectin reagent, a world standard in gene therapy protocols. Takara Bio is committed to preventing disease and improving the quality of life for all people through the use of biotechnology. ... Visa mer
About Takara Bio:
Takara Bio is a world leader in biotechnology research and development, offering a host of life science research solutions, from enzymes and GMP-grade reagents to contracted cell and gene therapy manufacturing services and is the developer of the RetroNectin reagent, a world standard in gene therapy protocols. Takara Bio is committed to preventing disease and improving the quality of life for all people through the use of biotechnology.

About Takara Bio AB:

Takara Bio Europe AB (formerly Cellartis, in Gothenburg, Sweden), a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both iPS cells and ES cells and related media development. The company leverages long-standing experience in stem cell reprogramming, genome editing, scale-up and differentiation into various types of mature and functional human cells.

About the job:
We are looking for a dynamic, organized, and autonomous Product Manager for our Stem Cell product portfolio (RUO & GMP media, cells & services).

Key duties and responsibilities:
Manage stem cell product line: coordinate product developments, launch processes, product lifecycle management, promotions, product line reviews.
Coordinate information flows to all affiliates, support sales by providing material, training, attend customer discussions.
Develop tactical marketing plans and contribute to the strategic plans in collaboration with the Market Strategy Management team.
Manage and develop the stem cell IP portfolio in collaboration with the Manager Intellectual Property.
Lead customer collaboration projects: evaluate, define needs, provide technical expertise (or coordinate with technical expert), follow up until project completion.


Required:
PhD in cell biology or stem cell research.
2 years of job experience in a project leader, product development, marketing, sales or business development role in the stem cell or related biotechnology industry.
Excellent oral and written communication & presentation skills in English.
Strong organisational skills.

We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated, and competent colleagues with whom you can both laugh and work. Visa mindre

QA/QC Associate

Quality Assurance and Quality Control Associate to Takara Bio Europe About the company: Takara Bio Europe, formerly Cellartis, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, th... Visa mer
Quality Assurance and Quality Control Associate to Takara Bio Europe
About the company: Takara Bio Europe, formerly Cellartis, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. Takara Bio Europe has a newly established GMP laboratory for production of pluripotent stem cell lines and related media. For more information, visit our website: www.takarabio.com


About the position: The Takara Bio Europe is now looking for a person joining our Quality team. As a part of our team, you will be working hands on with environmental control in the clean rooms, with bioanalytical methods (such as Flow Cytometry, SDS-PAGE, PCR, Immunostaining) and cell culture-based assays in the wet lab as well as more administrative tasks related to the QMS (Quality management system).
We are working with research grade as well as GMP (Good Manufacturing Practice) grade products which requires knowledge and adherence to Quality principles and standards including GMP and pharmacopoeia methods. Our new team member will after appropriate training work independently, executing the tasks in alignment with our QMS.

General Duties & Responsibilities
Performs routine work independently and adds new tasks after training
Relies on instructions and pre-established guidelines when executing tasks.
Maintains knowledge of Quality principles and theories including Good Manufacturing Practice (GMP), ISO 9001:2015 and pharmacopoeia standards for QC methods
Maintains knowledge of Quality processes and standards.
Cooperation with production and supply chain teams


Primary Duties & Responsibilities
Perform environmental control of clean room areas in the facility.
Perform quality control assays, including cell culture-based assays of stem cell products and media
Issue, review and assess batch related documentation and environmental control documentation
Work with Deviations, Change Controls and risk assessments
Manage and implement QMS documentation during review and approval process
Follow company Quality Management System processes and procedures; Good Manufacturing Practice (GMP) and ISO 9001/2015.
Maintenance and development of Quality processes and procedures
Support in customer audits and authority inspection
Take part in general maintenance activities in the clean room area.
Review qualification and validation documentation of equipment, systems and processes
Perform internal audit
Assess and Trend environmental control results.


Relevant education and experience
BSc or MSc in Cell Biology, Molecular Biology, Microbiology, Pharmacy, or related field
>3 years relevant experience preferably in the biotech, biologics and/or pharmaceutical area
Hands-on experience of work in the wet lab as well as cell culture
Experience of work in QA department (QMS, deviations, audits etc) in regulated area (GMP and/or ISO 9001)
Experience of work in clean room area within GMP is an advantage
Experience of work with ATMP products is an advantage
Knowledge about applicable guidelines is an advantage
Flexible and capable of handling multiple projects and changing priorities
Good command of the English language in speaking and writing


We are looking for you who are enjoying having a variety of tasks performed in a quality regulated environment. You will be working independently, being an important part of our company to offer stem cell products to the market. We can offer you a familiar environment where each person is doing a difference.


Postion: QA/QC Associate, full time, temporary position 11 months, reporting to QA/QC Manager. Scheduled work performed during weekends may from time to time be a requirement.
Welcome with your application no later than November 22, 2022. We will start the evaluation of candidates as they arrive, and the position can be filled before due date.
For more information and application, please contact [email protected]
phone +46 765 25 09 61 Visa mindre

Quality Control Associate

Quality Control Associate to Takara Bio Europe Takara Bio Europe, formerly Cellartis, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in hum... Visa mer
Quality Control Associate to Takara Bio Europe
Takara Bio Europe, formerly Cellartis, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. Takara Bio Europe has a newly established GMP laboratory for production of pluripotent stem cell lines and related media. For more information, visit our website: www.takarabio.com
Takara Bio Europe is now looking for a person joining our expanding Quality team. As a part of our team, you will be working with environmental control in the clean rooms as well as with bioanalytical methods (such as Flow Cytometry, SDS-PAGE, PCR, Immunostaining) and cell culture-based assays in the wet lab.
We are working with research grade as well as GMP (Good Manufacturing Practice) grade products which requires knowledge and adherence to Quality principles and standards including GMP and pharmacopoeia methods. Our new team member will after appropriate training work independently, executing the tasks in alignment with our QMS (Quality Management System).
General Duties & Responsibilities
Performs routine work independently and adds new tasks after training
Relies on instructions and pre-established guidelines when executing tasks.
Maintains knowledge of Quality principles and theories including Good Manufacturing Practice (GMP), ISO 9001:2015 and pharmacopoeia standards for QC methods
Maintains knowledge of Quality Control processes and standards.
Cooperation with production and supply chain team


Primary Duties & Responsibilities
Perform environmental control of clean room areas in the facility.
Perform quality control assays, including cell culture-based assays of stem cell products and media.
Issue, review and assess QC batch related documentation and environmental control documentation
Take part in Deviations, Change Controls and risk assessments related to quality control.
Participate in qualification and validation activities of QC equipment, systems and processes
Act as contact person for external suppliers for QC service.
Follow company Quality Management System processes and procedures; Good Manufacturing Practice (GMP) and ISO 9001/2015.
Maintenance and development of Quality Control processes and procedures.
Provide QC support in relation customer audits and authority inspection
Take part in general maintenance activities in the clean room area.
Assess and Trend environmental control results.


Relevant education and experience
BSc or MSc in Cell Biology, Molecular Biology, Microbiology, Pharmacy, or related field
>3 years relevant experience preferably in the biotech, biologics and/or pharmaceutical area
Hands-on experience of work in the wet lab as well as cell culture
Experience of work in clean room area within GMP is an advantage
Analytical mindset, assay development and troubleshooting skills are an advantage
Experience of work with ATMP products is an advantage
Knowledge about applicable guidelines is an advantage
Experience of hands-on work with flow cytometry is an advantage
Flexible and agile, capable of handling multiple projects and changing priorities
Good command of the English language in speaking and writing


We are looking for you who are enjoying having a variety of tasks performed in a quality regulated environment. You will be working independently, being an important part of our company to offer stem cell products to the market. We can offer you a familiar environment where each person is doing a difference.

Position
Quality Control Associate, full time, permanent position, reporting to QA/QC Manager. Scheduled work performed during weekends may from time to time be a requirement.
Welcome with your application no later than August 22, 2022. We will start the evaluation of candidates beginning of August and the position can be filled before due date.
For more information, please contact [email protected], +46 765 25 09 61 Visa mindre

GMP Media Production Associate

GMP Media Production Associate Company: Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both iPS cells and ES cells and related media development. The company leverages long-standing experience in stem cell reprogramming, genom... Visa mer
GMP Media Production Associate

Company:
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both iPS cells and ES cells and related media development. The company leverages long-standing experience in stem cell reprogramming, genome editing, scale-up and differentiation into various types of mature and functional human cells. The company is located in Gothenburg, Sweden.

As part of our GMP media manufacturing team, you are expected to be hands-on working, and on some occasions take responsibility for the manufacturing of our GMP media products, maintenance of laboratory and equipment. Manufacturing related administrative tasks are also included.
You will be trained and work in processes connected with the GMP and research-grade production (RUO) manufacturing, such as planning productions, performing lab related task, and controlling the stocks and inventory.
This position requires a person with a detail-oriented mindset that thrives in a dynamic environment.
We are looking for a person that can switch easily between tasks, be happy performing operations on a daily base and at the same time have the plasticity to focus and perform office related work.

General tasks and responsibilities:
· Team member in our GMP production team.
· Support the GMP Production Manager when required.
· Plan and produce GMP and RUO stem cell related media products.
· Implementation of new products.
· Reports to our GMP Media Production Manager.
· Works in close collaboration with RUO, QC/QA, Supply Chain and Product Manager.
· Accurate documentation and data compilation.
· Implementing new or update SOPs for GMP and RUO medium production procedures.
· Perform assigned tasks requiring the application of standard procedures and techniques.
· Responsible for reporting deviations and change of control.
· Maintain cost efficient operations.
· Comply with quality standards, such as ISO9001.
· Additional duties as assigned.
· Work on evenings may occur.
It is a full-time position, time-limited to December 2023, with the possibility of extension. Start date 2022-07-01 or as per agreement.
We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated, and competent colleagues with whom you can both laugh and work.
You are welcome with your application no later than June 30th, 2022. Please note that we will have an ongoing review of candidates.
Contact person: Joana Real ([email protected]) Visa mindre

GMP Cell Production Associate

Ansök    Jul 21    Takara Bio Europe AB    Laborant, biologi
Company: Takara Bio Europe (formerly Cellartis), a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells (hPSC), including both iPS cells and ES cells and related media development. The company leverages long-standing experience in stem cell reprogramming, CRISPR gene ed... Visa mer
Company:
Takara Bio Europe (formerly Cellartis), a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells (hPSC), including both iPS cells and ES cells and related media development. The company leverages long-standing experience in stem cell reprogramming, CRISPR gene editing, scale-up and differentiation into many different types of mature and functional human cells.

Takara Bio Europe AB has GMP facilities for production of human pluripotent stem cell lines and their derivatives intended for use in cell therapy under MPA and FDA regulations. The company is located in Gothenburg, Sweden.

About The Position:
We are looking for a detail-oriented person to join our cell manufacturing team. The role is laboratory-based and the selected candidate is expected to work in our team for stem cell based manufacturing activities, mainly in our GMP facility but also in our research grade laboratory when required. As part of your duties, you will also participate bioprocess development of our cell manufacturing and tech transfer to the GMP facility.

Responsibilities:
· Team member in our cell manufacturing team.
· Production of stem cell related products and services.
· Work in our GMP facility as well as the research grade laboratory.
· Work according to GMP production schedules and instructions (e.g., SOP, MBR)
· Prepare, review, and revise GMP documentation.
· Initiation and handling deviation, change control, CAPA.
· Support tech transfer activities from the internal and external.
· Identify, evaluate, and implement new processes for production of existing cell products.
· Participate in implementation of new products and services.
· Works in close collaboration with supply chain, QA/QC, QP team.
· Additional duties as assigned.
· Work on weekends on monthly basis.

Qualifications:
· BSc/MSc/PhD in Cell Biology, Molecular Biology, Microbiology, Pharmacy, or related field.
· >3 years biological manufacturing relevant experience, preferably in the biotech, biologics and/or pharmaceutical area.
· Exposure to ISO 9001, ISO 13485 quality management system is an asset.
· Good understanding and application of GMP and regulatory requirements is preferred.
· Experience of work in clean room area within GMP is preferred.
· Experience of work with ATMP products is an advantage.
· General knowledge of biological raw materials, cell culture and cell culture media.
· Hands on experience with mammalian cell culture and aseptic techniques. Experience in culture, differentiation of pluripotent stem cells and scale-up bioprocessing (e.g. Cell Factory for adherent cell culture, Bioreactor for cell suspension culture) is an asset.

The position is permanent and full time.

We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated and skilled colleagues with whom you can both laugh and work.

You are welcome with your application no later than August 31st, 2022. Please note that we will have an ongoing review of candidates.

For more information about the position, please contact Dr. Yu Zhang ([email protected])

You can find out more about Takara Bio at https://www.takarabio.com
Life in Gothenburg: https/www.movetogothenburg.com Visa mindre

Director, Product & Service Development

Ansök    Mar 24    Takara Bio Europe AB    Kemist
Position Summary/Objective: Oversees and coordinates product & service development/project teams from conception through development cycle. Responsible for transferring technical know-how from the group companies. Implements and communicates the strategic and technical direction for the product/project team. Identifies customer needs for specific projects and programs and manages their development and execution. Interacts with marketing, manufacturing, and... Visa mer
Position Summary/Objective:
Oversees and coordinates product & service development/project teams from conception through development cycle. Responsible for transferring technical know-how from the group companies. Implements and communicates the strategic and technical direction for the product/project team. Identifies customer needs for specific projects and programs and manages their development and execution. Interacts with marketing, manufacturing, and regulatory departments and with external stakeholders. Prepares strategic pre-launch and pre-marketing plans and provides input into development of long- and short-term marketing strategies. Identifies any issues that may delay product or project and recommends appropriate action to be taken. Plans and directs schedules and monitors budget/spending.

Director, Product & Service Development role is office-based.

Essential Functions:
Creating and enhancing products and services that are competitive in the market.
Lead product and service development projects. Collaborate with Marketing team to define product and service for unmet needs, setting product specifications, product launch and retiring products when necessary.
Supporting manufacturing and design activities by developing prototypes for products in development and help tech transfer from group (mainly Japan and China).
Supporting feasibility study, quote, implementation of customer’s service project by providing a technical advice to the service operation team.
Supporting technical support team by providing a technical advice on stem cell products.
Supporting a trouble shooting and/or cost down projects made at manufacturing team by providing a technical advice.


Education/Certification, Experience, and Competencies:
Requires a MS or PhD.
Typically requires a minimum of 10 years of career growth in a product and/or service development role or equivalent.
Demonstrated proficiency in presenting, written and verbal communication skills is required.
Proficient with Microsoft Office.
Must be detail-oriented and have strong organizational and time management skills.
The ability to work independently and creatively is required. Visa mindre

Logistic Associate to Takara Bio Europe AB

Logistic Associate to Takara Bio Europe AB Company Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad exp... Visa mer
Logistic Associate to Takara Bio Europe AB


Company
Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. Takara Bio Europe AB is located in state-of-the-art facilities in Göteborg, Sweden and has a newly established GMP laboratory for production of pluripotent stem cell lines and culture media. For more information, visit our website: www.takarabio.com.
Takara Bio Europe AB is now looking for a logistic associate joining our Supply Chain team. As a part of our team, you will be working hands-on with reception and packing and delivery of goods as well as with administrative tasks related to shipment of goods world-wide according to regulatory guidelines. Takara Bio Europe AB is an authorized consignee distributing temperature sensitive goods and is utilizing one local warehouse as well as one external warehouse in France.
This position reports to the Associate Director Supply Chain Management.


Primary Duties & Responsibilities
Preparation of documents associated with shipments within EU as well as world-wide deliveries, including custom invoice, declaration of goods and delivery note
Communicate with customers and provide any necessary documentation
Coordinate shipments from the external warehouse in France
Book deliveries for ground and air freight
Track deliveries
Manage packaging and distribution facility
Secure supply of packaging material
Picking and packaging of goods, including handling of dry ice and liquid nitrogen
Manage distribution according to requirements for Authorized consignees
Reception and control of incoming goods and registration in inventory
Follow company Quality Management System processes and procedures; ISO 9001/2015
Act as logistic contact person



General Duties & Responsibilities
Perform routine work independently, new tasks added after training.
Rely on instructions and pre-established guidelines when executing tasks.
Maintain knowledge of Regulatory guidelines and Quality principles such as ISO 9001/2015.
Other required duties may be assigned.



Education/Experience Requirement
Associate’s or Bachelor’s degree in Logistics or related field
1-3 years relevant job experience in related field
Knowledge about applicable regulatory framework
Flexible and capable of handling multiple tasks
Good command of the English language in speaking and writing


We want you to be able to act with high accuracy in a rapid and flexible manner, are enjoying having a variety of different tasks and want to work both with administrative tasks and hands-on with picking and packaging. We offer you a familiar and dynamic environment where each person in the team makes a difference.

Position
Logistic Associate, full time

Welcome with your application no later than December 12, 2021. We apply continuous evaluation of applicants; therefore, this position can be filled before due date.

For more information, please contact [email protected]
Phone +46 765 25 09 72 Visa mindre

Associate/Scientist, Research grade and GMP Cell Manufacturing

Ansök    Mar 21    Takara Bio Europe AB    Biolog
Company: Takara Bio Europe AB (Cellartis), a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both iPS cells and ES cells and related media development. The company leverages long-standing experience in stem cell reprogramming, genome editing, scale-up an... Visa mer
Company:
Takara Bio Europe AB (Cellartis), a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both iPS cells and ES cells and related media development. The company leverages long-standing experience in stem cell reprogramming, genome editing, scale-up and differentiation into various types of mature and functional human cells.

Takara Bio Europe AB has GMP facilities for production of pluripotent stem cell lines and their derivatives intended for use in cell therapy under MPA and FDA regulations. The company is located in Gothenburg, Sweden.

Our team is growing and we are looking for a detail-oriented person to join our cell manufacturing team. The role is laboratory-based and the selected candidate is expected to work in our team for stem cell based manufacturing activities, both in our regular (research grade) facility but also in our GMP facility. As part of your duties, you will also participate bioprocess development of our cell manufacturing and tech transfer to the GMP facility.

Qualifications:
· Relevant (life science) education on MSc/PhD level.
· Excellent communication and collaboration skills.
· General knowledge of biological raw materials, cell culture and cell culture media.
· Hands on experience with mammalian cell culture and aseptic techniques. Experience in culture, differentiation of pluripotent stem cells and scale-up bioprocessing (e.g. Cell Factory for adherent cell culture, Bioreactor for cell suspension culture) is an asset.
· Exposure to ISO 9001, ISO 13485 quality management system and GMPs is an asset.
· Industry experience is desired but not mandatory.

General tasks and responsibilities include:
· Team member in our cell manufacturing team.
· Production of stem cell related products and services.
· Work in our research grade facility as well as the GMP facility.
· Optimize and upgrade our existing cell manufacturing processes for the purpose of improving efficiency, capacity and cost savings.
· Identify, evaluate, and implement new processes for production of existing cell products.
· Participate in implementation of new products and services.
· Adhere to the QA/QC system.
· Works in close collaboration with QA/QC/QP team.
· Additional duties as assigned.
· Work on weekends on monthly basis.
The position is permanent and full time.

We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated and skilled colleagues with whom you can both laugh and work.

You are welcome with your application no later than April 30th, 2022. Please note that we will have an ongoing review of candidates.

For more information about the position, please contact Dr. Yu Zhang ([email protected])

You can find out more about Takara Bio at https://www.takarabio.com
Life in Gothenburg: https/www.movetogothenburg.com Visa mindre

Scientist Cell Culture Media Development

Company: Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature an... Visa mer
Company:
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functional human cells, such as beta cells and hepatocytes. Takara Bio Europe AB has a GMP laboratory for production of pluripotent stem cell lines intended for use in cell therapy. The company is located in Göteborg, Sweden.

We are looking for a detail-oriented, scientifically driven person to join us. The role is mainly laboratory-based and the selected candidate is expected to focus on developing and expanding our media product portfolio as well optimize and upgrade our existing media manufacturing processes for the purpose of, improving efficiency, capacity and cost savings. The scientist will work closely with the Media Production team as well as the Cell Production team, but also with our Product managers.

Qualifications:
· Relevant (Life science) education (PhD or MSc with minimum of 3-5 years’ experience, Bachelor with minimum of 5-10 years’ experience)
· Excellent communication and collaboration skills
· General knowledge of biological raw materials, cell culture and cell culture media
· Good understanding of scale-up principles
Exposure to ISO 9001, ISO 13485 quality management system and cGMPs is an asset.



General tasks and responsibilities include:
· Develop and expand our media product portfolio
· Optimize and upgrade our existing media manufacturing processes for the purpose of improving efficiency, capacity and cost savings.
· Identify, evaluate, and implement new processes for production of existing media products
· Report to Director of Service Operations
· Adhere to the QA/QC system
· Work in close collaboration with QA/QC, QP and Cell Production Manager
· Additional duties as assigned

The position is permanent and full time.
We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated and skilled colleagues with whom you can both laugh and work
You are welcome with your application no later than December 5th, 2021. Please note that we will have an ongoing review of candidates.

For more information about the position, please contact Catharina Brandsten
(catharina_­ brandsten @takarabio.com)

You can find out more about Takara Bio at https://www.takarabio.com
Life in Gothenburg: https/www.movetogothenburg.com Visa mindre

Scientist

Ansök    Nov 3    Takara Bio Europe AB    Molekylärbiolog
Company: Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature an... Visa mer
Company:
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functional human cells, such as beta cells and hepatocytes. Takara Bio Europe AB has a GMP facility for production of pluripotent stem cell lines intended for use in cell therapy. The company is located in Göteborg, Sweden.

We are looking for an enthusiastic, problem-solving scientist who enjoys working in a service & product-oriented environment and is a strong team player. The role is partly laboratory-based and the successful candidate will work as project leader for stem cell-based service projects primarily within the Gene Editing team, but is also flexible, and may support other service projects and the Production unit when needed.

Preferred qualifications:
· Ph.D. in molecular biology, cell biology or relevant discipline
· Very knowledgeable and experienced in molecular biology techniques such as gene editing, CRISPR/Cas9, transfections, PCR, RT-PCR, gel electrophoresis, FACS, immunohistochemistry, etc.
· Very knowledgeable in general cell culture techniques.
· Experience with human pluripotent stem cells (hiPSC/hESC; derivation, culturing, differentiation) is desired but not required.
· Industrial experience desired but not required.

General tasks and responsibilities include:
· Act as project leader for gene editing service projects in close collaboration with the other project leaders within the Gene Editing team.
· Participate in other stem cell related service projects or stem cell work
· Investigate, develop, and set up new methods and technologies for project advancement.
· Set up, operate, and maintain laboratory equipment and apparatus.
· Assist in data interpretation and analyses.
· Process and summarize data using scientific or statistical techniques.
· Perform assigned tasks requiring the application of standard procedures and techniques.
· Adhere to the QA/QC system.
· Contribute data/findings for use in reports, documents, or verbal/written presentations.
· Support the cell production team when needed.
· Assist in contributions to scientific literature and conferences.
Work on weekends (approximately 1-2 times per month)

· Additional duties as assigned.


We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated, and skilled colleagues with whom you can both laugh and work.
You are welcome with your application no later than November 20, 2021. Please note that we will have an ongoing review of candidates.

For more information about the position, please contact Dr Annika Asplund ([email protected])

You can find out more about Takara Bio at https://www.takarabio.com
Life in Gothenburg: https://www.movetogothenburg.com/ Visa mindre

Quality Control Associate

Quality Control Associate to Takara Bio Europe AB Company Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad... Visa mer
Quality Control Associate to Takara Bio Europe AB
Company
Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. Takara Bio Europe AB is located in state-of-the-art facilities in Göteborg, Sweden and has a newly established GMP laboratory for production of pluripotent stem cell lines and culture media. For more information, visit our website: www.takarabio.com.
Takara Bio Europe AB is now looking for a person joining our expanding Quality team. As a part of our team, you will be working with environmental control in the clean rooms as well as with bioanalytical methods (such as SDS-PAGE, PCR, Flow Cytometry, Immunostaining) and cell culture-based assays in the wet lab. We are working with research grade as well as GMP (Good Manufacturing Practice) grade products which requires knowledge and adherence to Quality principles and standards including GMP and pharmacopoeia. Our new team member will after appropriate training work independently, executing the tasks in alignment with our QMS (Quality Management System).
Scheduled work performed during weekends may from time to time be a requirement as we are working with living cells. This position reports to the QA/QC Manager.


General Duties & Responsibilities
Performs routine work independently and adds new tasks after training
Relies on instructions and pre-established guidelines when executing tasks.
Maintains knowledge of Quality principles and theories including Good Manufacturing Practice (GMP) and ISO 9001/2015.
Maintains knowledge of Quality Control processes and standards.

· Other required duties may be assigned.

Primary Duties & Responsibilities
· Perform environmental control of clean room areas in the facility.
· Perform quality control assays, including cell culture-based methods of stem cell products.
· Issue, review and assess QC batch related documentation and environmental control documentation
· Write and revise SOPs in order to maintain and develop the Quality Control processes and procedures.
· Take part in Deviations, Change Controls and risk assessments related to quality control.
· Participate in qualification and validation activities of QC equipment, systems and processes
· Act as contact person for external suppliers for QC service.
· Follow company Quality Management System processes and procedures; Good Manufacturing Practice (GMP) and ISO 9001/2015.
· Provide support with audit/inspection requirements to ensure department compliance/readiness.
· Take part in general maintenance activities in the clean room area.
· Assess and Trend environmental control results.

Education/ Experience Requirement
· BSc or MSc in Pharmacy, Cell Biology, Microbiology or related field
· >3 years relevant experience preferably in the biotech, biologics, medtech, and/or pharmaceutical area
· Hands-on experience of work in the wet lab as well as with cell culture is an advantage
· Experience of work in clean room area within GMP is an advantage
· Experience of work with ATMP products is an advantage
· Knowledge about applicable Quality guidelines is an advantage
· Flexible and agile, capable of handling multiple tasks and changing priorities
· Good command of the English language in speaking and writing

We are looking for you who can act in a rapidly developing field, are flexible and are enjoying having a variety of different tasks. We can offer you a familiar and dynamic environment where each person in the team makes a difference.


Position
Quality Control Associate, full time, 12 months contract, with the possibility it will become a permanent position.
Welcome with your application no later than November 22, 2021. We apply continuous evaluation of applicants; therefore, this position can be filled before due date.
For more information, please contact [email protected]
Phone +46 765 25 09 72 Visa mindre

Cell Production Associate

Ansök    Okt 19    Takara Bio Europe AB    Molekylärbiolog
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functio... Visa mer
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functional human cells, such as beta cells and hepatocytes. Takara Bio Europe AB has a GMP laboratory for production of pluripotent stem cell lines intended for use in cell therapy. The company is located in Göteborg, Sweden.

We are looking for a detail-oriented person to join our cell production team. The role is laboratory-based and the selected candidate is expected to work in our team for stem cell based activities, both in our regular (research grade) facility but also in our GMP facility.
As part of the cell production team, you will be working with human pluripotent stem cells and you will differentiate the hPS cells to mature cells, like liver, heart or insulin producing cells. As part of your duties, you will be responsible for the lifecycle management of our cell GMP facility.

Preferred qualifications:
· Relevant (Life science) education on MSc level
· Excellent communication and collaboration skills
· Experience in a GMP bioprocess environment

General tasks and responsibilities include:
· Team member in our cell production team
· Production of stem cell related products and services
· Work in our research/production facility as well as the GMP facility
· Life cycle management of equipment and facility
· Prepare annual maintenance & calibration plans for the equipment
· Coordinate maintenance and calibrations with external supplier
· Participate in implementation of new products and services
· Reports to Cell Production Manager
· Adhere to the QA/QC system
· Works in close collaboration with QA/QC, QP and Cell Production Manager
· Additional duties as assigned
· Work on weekends on monthly basis
The position is permanent and full time.
We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated and skilled colleagues with whom you can both laugh and work
You are welcome with your application no later than November 5th, 2021. Please note that we will have an ongoing review of candidates. Visa mindre

Quality Control Associate

Ansök    Okt 29    Takara Bio Europe AB    Biomedicinare
Quality Control Associate to Takara Bio Europe AB Company Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broa... Visa mer
Quality Control Associate to Takara Bio Europe AB
Company
Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. Takara Bio Europe AB is located in state-of-the-art facilities in Göteborg, Sweden and has a newly established GMP laboratory for production of pluripotent stem cell lines and culture media. For more information, visit our website: www.takarabio.com.
Takara Bio Europe AB is now looking for a person joining our expanding Quality team. As a part of our team, you will be working with environmental control in the clean rooms as well as with bioanalytical methods (such as SDS-PAGE, PCR, Flow Cytometry, Immunostaining) and cell culture-based assays in the wet lab. We are working with research grade as well as GMP (Good Manufacturing Practice) grade products which requires knowledge and adherence to Quality principles and standards including GMP and pharmacopoeia. Our new team member will after appropriate training work independently, executing the tasks in alignment with our QMS (Quality Management System).
Scheduled work performed during weekends may from time to time be a requirement as we are working with living cells. This position reports to the QA/QC Manager.

General Duties & Responsibilities
Performs routine work independently and adds new tasks after training
Relies on instructions and pre-established guidelines when executing tasks.
Maintains knowledge of Quality principles and theories including Good Manufacturing Practice (GMP) and ISO 9001/2015.
Maintains knowledge of Quality Control processes and standards.

· Other required duties may be assigned.

Primary Duties & Responsibilities
· Perform environmental control of clean room areas in the facility.
· Perform quality control assays, including cell culture-based methods of stem cell products.
· Issue, review and assess QC batch related documentation and environmental control documentation
· Write and revise SOPs in order to maintain and develop the Quality Control processes and procedures.
· Take part in Deviations, Change Controls and risk assessments related to quality control.
· Participate in qualification and validation activities of QC equipment, systems and processes
· Act as contact person for external suppliers for QC service.
· Follow company Quality Management System processes and procedures; Good Manufacturing Practice (GMP) and ISO 9001/2015.
· Provide support with audit/inspection requirements to ensure department compliance/readiness.
· Take part in general maintenance activities in the clean room area.
· Assess and Trend environmental control results.

Education/ Experience Requirement
· BSc or MSc in Pharmacy, Cell Biology, Microbiology or related field
· >3 years relevant experience preferably in the biotech, biologics, medtech, and/or pharmaceutical area
· Hands-on experience of work in the wet lab as well as with cell culture is an advantage
· Experience of work in clean room area within GMP is an advantage
· Experience of work with ATMP products is an advantage
· Knowledge about applicable Quality guidelines is an advantage
· Flexible and agile, capable of handling multiple tasks and changing priorities
· Good command of the English language in speaking and writing

We are looking for you who can act in a rapidly developing field, are flexible and are enjoying having a variety of different tasks. We can offer you a familiar and dynamic environment where each person in the team makes a difference.

Position
Quality Control Associate, full time, 12 months contract, with the possibility it will become a permanent position.
Welcome with your application no later than November 22, 2021. We apply continuous evaluation of applicants; therefore, this position can be filled before due date.

For more information, please contact [email protected]
Phone +46 765 25 09 72 Visa mindre

Media Production Associate

Ansök    Okt 14    Takara Bio Europe AB    Molekylärbiolog
As part of our media manufacturing team, you are expected to be hands-on working, and to some extent take responsibility for the manufacturing of our media products, maintenance of laboratory and equipment. Manufacturing related administrative tasks are also included. You will be trained in processes connected with the manufacturing, such as planning productions, performing lab related task and controlling the stocks and inventory. You will be working bot... Visa mer
As part of our media manufacturing team, you are expected to be hands-on working, and to some extent take responsibility for the manufacturing of our media products, maintenance of laboratory and equipment. Manufacturing related administrative tasks are also included.
You will be trained in processes connected with the manufacturing, such as planning productions, performing lab related task and controlling the stocks and inventory.
You will be working both in our research-grade production unit with media production and you will also be trained for work within our new GMP media facility.
This position requires a person with a detail-oriented mindset that thrives in a dynamic environment.

General tasks and responsibilities:
· Team member in our production team
· Production of stem cell related media products
· Implementation of new products
· Reports to our Media Production Managers
· Works in close collaboration with QC and Product Manager
· Accurate documentation and data compilation
· Perform assigned tasks requiring the application of standard procedures and techniques
· Comply with quality standards, such as ISO9001
· Additional duties as assigned
· Work on evenings may occur
The position is permanent and full time.

We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated, and competent colleagues with whom you can both laugh and work.
You are welcome with your application no later than October 31st, 2021. Please note that we will have an ongoing review of candidates. Visa mindre

GMP Facility Manager at Takara Bio Europe AB

Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. Takara Bio Europe AB has GMP facilities for production of (i) pluripotent stem cell lines for use in cell therapy and (ii) GMP grade cell culture media. The ... Visa mer
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. Takara Bio Europe AB has GMP facilities for production of (i) pluripotent stem cell lines for use in cell therapy and (ii) GMP grade cell culture media. The company is located in Göteborg, Sweden.

We are looking for an enthusiastic, problem-solving, and driven person who enjoys working with a team in a product & service-oriented environment. The GMP Facility Manager is an engineer/laboratory technician, preferably with experience from the pharmaceutical industry. The GMP Facility Manager will work in close collaboration with Qualified Person (QP) as well as with the Managers for Cell Production and Media Production.

Key requirements:
· Relevant education on MSc level such as an engineering degree with a life science profile
· Experience with GMP manufacturing, preferably of ATMP products, or experience in other regulated industry, such as medical devices, biologics, or diagnostics
· Significant knowledge of GMP regulations
· Excellent communication and collaboration skills
· Good in creating and following up plans and schedules
· Good leadership skills

General tasks and responsibilities include:
· Coordinating the maintenance of the GMP Manufacturing facilities and the non-classified laboratories.
· Ensuring cleanrooms and equipment are monitored, maintained and available for production.
· Drafting facility annual expense and capital budgets and preparing annual maintenance and calibration plans.
· Performing maintenance and calibration in collaboration with team members and external suppliers.
· Administering the facility related SOPs.
· Providing support for the production and QC teams in problem-solving related to maintaining quality compliance. Directing SOP preparation, adherence and compliance.
· Together with the QP, accountable for continuous audit readiness for GMP inspections.
Providing support for the facility’s consistent adherence to compliance through participation in internal and external audits.

· Training and mentoring of team members.
· Additional duties as assigned


We are a highly motivated and skilled team that wants to make a difference. Do you want to join us? You will get friendly, supportive and competent colleagues with whom you can both laugh and work.
You are welcome with your application anytime before October 1, 2021. Please note that we will have an ongoing review of candidates.

For more information about the position, please contact Kristina Runeberg, Site Head, ([email protected]).

You can find out more about Takara Bio at https://www.takarabio.com
Life in Göteborg: https://www.movetogothenburg.com/ Visa mindre

Cell Production Associate

Ansök    Jul 16    Takara Bio Europe AB    Molekylärbiolog
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functio... Visa mer
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functional human cells, such as beta cells and hepatocytes. Takara Bio Europe AB has a GMP laboratory for production of pluripotent stem cell lines intended for use in cell therapy. The company is located in Göteborg, Sweden.

Now we are looking for a new member to our cell production team. The role is laboratory-based and the selected candidate is expected to work as a leader for our stem cell based activities, but may also support our service projects.

As part of the cell production team, you will be working with human pluripotent stem cells and you will differentiate the hPS cells to mature cells, like liver, heart or insulin producing cells. You are expected to be hands-on working, and to some extent be manufacturing of our cell products, test our cell related kits, maintenance of laboratory and equipment.
The role will be mainly laboratory-based and you will be trained in processes like manufacturing and quality control of stem cell based manufacturing and services to gain knowledge required for actual tasks. Some manufacturing related administrative tasks are also included.
You will be working mainly in our research-grade production unit with cell production but may also be trained for work within our GMP facility.

Preferred qualifications:
· M.Sc/B.Sc in Cell biology, Biotechnology or equivalent experience
· Good excellent communication and collaborations skills

General tasks and responsibilities include:
· Team member in our cell production team
· Production of stem cell related products and services
· Work in our research/production facility as well as the GMP facility
· Participate in implementation of new products and services
· Reports to Cell Production and Service Managers
· Works in close collaboration with QC and Cell Production Manager
· Accurate documentation and data compilation
· Perform assigned tasks requiring the application of standard procedures and techniques
· Comply with quality standards
· Additional duties as assigned
· Work on weekends on monthly basis
· Work on evenings on a bi-weekly basis

We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated and skilled colleagues with whom you can both laugh and work
You are welcome with your application no later than August 20, 2021. Please note that we will have an ongoing review of candidates.

For more information about the position, please contact Catharina Brandsten (catharina­[email protected])

You can find out more about Takara Bio at https://www.takarabio.com Visa mindre

Kvalificerad Redovisningsekonom till Takara Bio Europe AB

Takara Bio Europe AB, en del av Takara Bio-gruppen, fokuserar på stamcellsbaserade produkter och tjänster för cellterapi/regenerativ medicin, läkemedelsutveckling och modellering av sjukdomar. Företaget har bred expertis inom mänskliga pluripotenta stamceller, inklusive både hiPSC och hESC och relaterade medier. Företaget utnyttjar mångårig erfarenhet av stamcellshantering med ledande expertis inom differentiering av celler till mogna och funktionella mäns... Visa mer
Takara Bio Europe AB, en del av Takara Bio-gruppen, fokuserar på stamcellsbaserade produkter och tjänster för cellterapi/regenerativ medicin, läkemedelsutveckling och modellering av sjukdomar. Företaget har bred expertis inom mänskliga pluripotenta stamceller, inklusive både hiPSC och hESC och relaterade medier. Företaget utnyttjar mångårig erfarenhet av stamcellshantering med ledande expertis inom differentiering av celler till mogna och funktionella mänskliga celler, såsom betaceller och hepatocyter. Takara Bio Europe AB har en GMP -anläggning för produktion av pluripotenta stamcellslinjer avsedda att användas vid cellterapi. Företaget ligger i Göteborg, Sverige.


Vi letar efter en entusiastisk, kunnig och noggrann Redovisning ekonom med start snarast.


Arbetsuppgifter och ansvarsområden
· Kundreskontra
· Leverantörsreskontra
· Momsredovisning
· Skatteinbetalningar
· Löpande bokföring
· Avstämningar
· Statistik
· Månadsbokslut
· Underlag till månads-, kvartals- och årsredovisning
· Medverka vid intern och extern rapportering på månads-, kvartals- och årsbasis
· Medverka vid budgetering
· Löneadministration


Bakgrund
Vi söker dig som har relevant utbildning med väl dokumenterade praktiska erfarenheter inom redovisning, löneadministration och som är väl förtegen med rådande lagstiftning och regelverk. Personen som vi söker ska vara noggrann och strukturerad i sitt arbete och kunna sköta sina uppgifter med stort eget driv. Vidare är det av stor vikt att du levererar i tid med hög kvalitet, är självgående och trygg i din roll. Du bör även vara prestigelös och kunna hjälpa till där det behövs i den här rollen.

Vänligen skicka den ansökan till [email protected] senast den19 oktober
Har du frågor om tjänsten kan du kontakta Peter Rabe på mailadressen enligt ovan.
Intervjuer med aktuella personer kommer ske löpande så tjänsten kan komma att tillsättas före ansökningstidens utgång Visa mindre

Senior GMP Process and Facility Manager at Takara Bio Europe AB

Ansök    Jul 16    Takara Bio Europe AB    Molekylärbiolog
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functio... Visa mer
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functional human cells, such as beta cells and hepatocytes. Takara Bio Europe AB has a GMP facility for production of pluripotent stem cell lines intended for use in cell therapy. The company is located in Göteborg, Sweden.

We are looking for an enthusiastic, problem-solving, scientifically driven person enjoying working with a team in a service & product-oriented environment. The Senior GMP Process and Facility Manager will work in close collaboration with our QP as well as with the Managers for Cell and Media production.

Key requirements:
· Relevant (Life science) education on MSc level
· Excellent experience in a GMP bioprocess environment is required
· Significant knowledge of GMP regulations
· Excellent communication and collaboration skills
· Good leadership skills

General tasks and responsibilities include:
· Provide support to the production teams in problem-solving relating to maintaining quality compliance and has oversight for SOP preparation, adherence and compliance.
· Together with the QP, accountable for continuous audit readiness for routine GMP inspections and pre-approval inspections through ongoing inspection preparation for the manufacturing facilities.
Support consistent adherence to compliance through participation in Internal and External audits.

· Life cycle management of equipment and facilities
· Train and mentor team members
· Additional duties as assigned


We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated and skilled colleagues with whom you can both laugh and work.
You are welcome with your application no later than August 20, 2021. Please note that we will have an ongoing review of candidates.

For more information about the position, please contact Catharina Brandsten (catharina­ brandsten @takarabio.com)

You can find out more about Takara Bio at https://www.takarabio.com
Life in Gothenburg: https://www.movetogothenburg.com/ Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functional human cells, such as beta cells and hepatocytes. Takara Bio Europe AB has a GMP facility for production of pluripotent stem cell lines intended for use in cell therapy. The company is located in Göteborg, Sweden.

We are looking for an enthusiastic, problem-solving, scientifically driven person enjoying working with a team in a service & product-oriented environment. The Senior GMP Process and Facility Manager will work in close collaboration with our QP as well as with the Managers for Cell and Media production.

Key requirements:
· Relevant (Life science) education on MSc level
· Excellent experience in a GMP bioprocess environment is required
· Significant knowledge of GMP regulations
· Excellent communication and collaboration skills
· Good leadership skills

General tasks and responsibilities include:
· Provide support to the production teams in problem-solving relating to maintaining quality compliance and has oversight for SOP preparation, adherence and compliance.
· Together with the QP, accountable for continuous audit readiness for routine GMP inspections and pre-approval inspections through ongoing inspection preparation for the manufacturing facilities.
Support consistent adherence to compliance through participation in Internal and External audits.

· Life cycle management of equipment and facilities
· Train and mentor team members
· Additional duties as assigned


We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated and skilled colleagues with whom you can both laugh and work.
You are welcome with your application no later than August 20, 2021. Please note that we will have an ongoing review of candidates.

For more information about the position, please contact CatharinaBrandsten (catharina_brandsten @takarabio.com)

You can find out more about Takara Bio at https://www.takarabio.com
Life in Gothenburg: https://www.movetogothenburg.com/ Visa mindre

Scientist position at Takara Bio Europe AB

Ansök    Jul 12    Takara Bio Europe AB    Molekylärbiolog
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functio... Visa mer
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functional human cells, such as beta cells and hepatocytes. Takara Bio Europe AB has a GMP facility for production of pluripotent stem cell lines intended for use in cell therapy. The company is located in Göteborg, Sweden.


We are looking for an enthusiastic, problem-solving scientist who enjoys working in a service & product-oriented environment. The role is partly laboratory-based and the successful candidate will work as project leader for stem cell-based service projects primarily within the Gene Editing team, but is also flexible, and may support other service projects and the Production unit when needed.

Preferred qualifications:
· Ph.D. or M.Sc. degree in molecular biology, cell biology or relevant discipline or proven experience as project leader from gene editing projects.
· Very knowledgeable in molecular biology techniques such as gene editing, CRISPR/CAS9, transfections, PCR, RT-PCR, immunohistochemistry, FACS, etc.
· General cell biology procedures and techniques.
· Experience with stem cells (hiPSC/hESC); derivation, culturing, differentiation is desired but not required.
· Industrial experience desired but not required.


General tasks and responsibilities include:
· Act as project leader for gene editing service projects.
· Contribute with molecular biology support to other service projects.
· Support the cell production team.
· Investigate, create, and develop new methods and technologies for project advancement.
· Set up, operate, and maintain laboratory equipment and apparatus.
· Processe and summarize data using scientific or statistical techniques.
· Assist in data interpretation and analyses.
· Perform assigned tasks requiring the application of standard procedures and techniques.
· Adhere to the QA/QC system.
· Assist in contributing data/findings for use in reports, documents, or verbal/written presentations.
· Assist in contributions to scientific literature and conferences.
Work on weekends on a monthly basis.

· Additional duties as assigned.


We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated and skilled colleagues with whom you can both laugh and work
You are welcome with your application no later than August 20, 2021. Please note that we will have an ongoing review of candidates. Visa mindre

Cell Production Manager at Takara Bio Europe AB

Ansök    Jul 12    Takara Bio Europe AB    Molekylärbiolog
Company: Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature an... Visa mer
Company:
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functional human cells, such as beta cells and hepatocytes. Takara Bio Europe AB has a GMP facility for production of pluripotent stem cell lines intended for use in cell therapy. The company is located in Göteborg, Sweden.

We are looking for an enthusiastic, problem-solving, scientifically driven person enjoying working with a team in a service & product-oriented environment. The role is laboratory-based and the selected candidate is expected to work as a leader for our stem cell based production activities.

Preferred qualifications:
· Ph.D. or M.Sc. degree in cell biology, biotechnology, or relevant discipline or proven experience as project manager from human stem cell-based projects
· Extensive hands-on expertise in pluripotent stem cell biology and stem cell culture techniques
· Significant expertise in and understanding of stem cell biology
· Experience with stem cell (hiPS/hESC) differentiation
· General cell biology procedures and techniques
· Excellent communication and collaboration skills
· Good leadership skills



General tasks and responsibilities include:
· Schedule cell manufacturing activities
· Train and mentor team members
· Be part of developing new and improved methods/products
· Hands on work, both in our research/production facility as well as in our GMP facility
· Set up, operate, and maintain laboratory equipment and apparatus.
· Process and summarize data
· Assist in data interpretation and analyses
· Adhere to the QA/QC system
· Assist in contributing data/findings for use in reports, documents, or verbal/written presentations.
· May participate in development of patent applications
Work on weekends on a monthly basis

· Additional duties as assigned



We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated and skilled colleagues with whom you can both laugh and work.
You are welcome with your application no later than August 20, 2021. Please note that we will have an ongoing review of candidates. Visa mindre

Production Associate

Ansök    Mar 15    Takara Bio Europe AB    Laborant, biologi
As part of the manufacturing team, you are expected to be hands-on working, and to some extent be responsible for manufacturing of our cell & media products, test our cell related kits, maintenance of laboratory and equipment. The role will be mainly laboratory-based and you will be trained in processes like manufacturing and quality control of stem cell based manufacturing and services to gain knowledge required for actual tasks. Some manufacturing relat... Visa mer
As part of the manufacturing team, you are expected to be hands-on working, and to some extent be responsible for manufacturing of our cell & media products, test our cell related kits, maintenance of laboratory and equipment.
The role will be mainly laboratory-based and you will be trained in processes like manufacturing and quality control of stem cell based manufacturing and services to gain knowledge required for actual tasks. Some manufacturing related administrative tasks are also included.
You will be working mainly in our research-grade production unit with media and cell production but may potentially also be trained for work within our new GMP facility.

General tasks and responsibilities:
· Team member in our production team
· Production of stem cell related products and services
· Implementation of new products and services
· Reports to Production and Service Managers
· Works in close collaboration with QC and Product Manager
· Accurate documentation and data compilation
· Perform assigned tasks requiring the application of standard procedures and techniques
· Comply with quality standards, such as ISO9001
· Additional duties as assigned
· Work on weekends on monthly basis
· Work on evenings on a bi-weekly basis
The position is permament and full time.

We look forward to receiving your application. Please send us your CV and cover letter as soon as possible as we will have an ongoing review of candidates. We will only contact selected candidates.
Contact person: [email protected] Visa mindre

Scientist position at Takara Bio Europe AB

Scientist position at Takara Bio Europe AB Company: Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling and scale-up together ... Visa mer
Scientist position at Takara Bio Europe AB
Company:
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells, such as beta cells and hepatocytes. Takara Bio Europe AB is located in state-of-the-art facilities in Göteborg, Sweden and has a GMP laboratory for production of pluripotent stem cell lines intended for use in cell therapy. For more information, visit our website: www.takarabio.com


We are looking for an enthusiastic, problem-solving scientist who enjoys working in a service & product-oriented environment. The role is partly laboratory-based and the successful candidate will work as project leader for stem cell-based service projects primarily within the Gene Editing team but is also flexible and may support other service projects and the Production unit when needed.


Experience:
· Ph.D. or M.Sc. degree in molecular biology, cell biology or relevant discipline or proven experience as project leader from gene editing projects.
· Very knowledgeable in molecular biology techniques such as gene editing, CRISPR/CAS9, transfections, PCR, RT-PCR, immunohistochemistry, FACS, etc.
· General cell biology procedures and techniques.
· Experience with stem cells (hiPSC/hESC); derivation, culturing, differentiation is desired but not required.
· Industrial experience desired but not required.




General tasks and responsibilities:
· Act as project leader for gene editing service projects.
· Contribute with molecular biology support to other service projects.
· Support Production unit.
· Investigates, creates, and develops new methods and technologies for project advancement.
· Set up, operates, and maintains laboratory equipment and apparatus.
· Processes and summarizes data using scientific or statistical techniques.
· Assist in data interpretation and analyses.
· Perform assigned tasks requiring the application of standard procedures and techniques.
· Adhere to the QA/QC system.
· Assist in contributing data/findings for use in reports, documents, or verbal/written presentations.
· Assists in contributions to scientific literature and conferences.
Work on weekends on a monthly basis.

· Additional duties as assigned. Visa mindre

Qualified Person (QP)/Quality Assurance

Ansök    Mar 15    Takara Bio Europe AB    Biomedicinare
Company Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, includi... Visa mer
Company
Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPS cells and hES cells and related media. Takara Bio Europe AB is located in state-of-the-art facilities in Göteborg, Sweden, and holds a Manufacturing license for the establishment of hES cell lines, hES cell banking and hiPS cell banking. The company is also expanding its operation into GMP-grade manufacturing of cell culture media. For more information, visit our website: www.takarabio.com
Description
Advanced Therapy Medicinal Products (ATMPs) is a new and promising area of therapeutics. The Qualified Person (QP) will be responsible for release of Good Manufacturing Practice (GMP) produced cell banks.
The Qualified Person will also be responsible for the Quality Management System governing all of Takara Bio Europe AB’s activities and needs to secure quality aspects throughout the company, extending to vendors, suppliers and consultants.
Strong organisational, leadership and team skills will be important to guide and align all stakeholders.
General tasks and responsibilities
· Serve as the Company’s Qualified Person.
· Review and release of GMP produced cell banks according to regulatory requirements and in accordance with the GMP manufacturing license.
· Maintain in-depth knowledge in Good Manufacturing Practice (GMP) and specifically GMP for ATMP clinical trial material.
· Maintain broad knowledge in Quality principles and theories.
· Lead and organise the maintenance and improvement of Takara Bio Europe’s GMP Quality system.
· Lead the implementation of the ISO9001 Quality Management System.
· Proactively identify and mitigate potential quality and safety risks.
· Provide guidance to colleagues on established company Quality policies and procedures.
· Provide guidance upon implementation of new procedures in accordance with GMP and regulatory expectations.
Specific tasks and responsibilities
• Overall handling of Takara Bio Europe AB’s Quality Management system
• Auditing
• Vendor qualification
• Risk Assessments
• Acting as host for regulatory inspections
• Serving as primary contact for the Swedish MPA for questions related to the GMP manufacturing license
• Providing the Tissue Establishment leader with regulatory advice when needed
Education Requirement (minimum)
· MSc in Pharmacy, Cell Biology or related field
Experience Requirement (minimum)
· Minimum of 5 years of experience in a GMP environment.
· Fulfill the requirements of a Qualified Person as detailed in EMA Eudralex volume 4, annex 16
· Experience from work as a Qualified Person named on a manufacturing license.
· Expert knowledge in GMP regulations (FDA/EU/ICH).
· Experience within biotechnology or biologics is essential and experience in the field of cell or gene therapy is considered an advantage.
· Strong knowledge in other Quality principles and concepts, in particular ISO 13485 or ISO 9001, is an advantage.
· Experience from work with contractors and suppliers, including hands on experience with external GMP audits


The Qualified Person can be placed at Takara Bio Europe’s site in Göteborg, Sweden, or elsewhere with regular travels to Göteborg.
The Qualified Person reports to the Site Head.
Submit your application no later than April 9, 2021. We apply continuous evaluation of applicants; therefore, this position can be filled before this due date.
For more information, please contact [email protected]
Phone +46 765 250 904 Visa mindre

Accouting Manager

The Accouting Manager will be responsible for supervising tracking and evaluating company’s accounting activities, and establishing a good financial controlling by developing and implementing process for collecting, analyzing, veryfing and reporting accounting information. Together with CEO and external professionals, the Accounting Manager will also involve as a supporting role of company’s general administration, including internal controls and human res... Visa mer
The Accouting Manager will be responsible for supervising tracking and evaluating company’s accounting activities, and establishing a good financial controlling by developing and implementing process for collecting, analyzing, veryfing and reporting accounting information. Together with CEO and external professionals, the Accounting Manager will also involve as a supporting role of company’s general administration, including internal controls and human resource related tasks.


Position Title: Accounting Manager
Department : Accounting and Administration
Reports to: CEO
Seniority Level: Mid-Senior level


Primary Duties & Responsibilities


· Establish financial reports to be sent to our parent company in Japan, and apply our monthly accounting control procedures;
· Work on intra-group consolidation with French subsidiary;
· Supervise Accounting Associates in the department;
· Ensure the preparation of budgets, their monthly follow-up, as well as the quarterly and year-end forecasts;
· Perform analytical determinations of people hours, consumables and fixed costs;
· Prepare Tax declarations;
· Manage our cash-flow;
· Organize our internal controls and audits;
· Coordinate our external audits and prepare Annual Report
· Organiza payroll;


General Duties & Responsibilities


· Works on problems of diverse scope where analyses of data require evaluation of identifiable factors.
· Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
· Networks with senior internal and external personnel in own area of expertise.
· Meeting the reporting deadline.


Education Requirement (minimum)


· BA or BS Degree in Accounting


Experience Requirement (minimum)


· Minimum 5 years related experiences working in Swedish SME, preferably in an international environment as well;
· Swedish Accounting Standard K3;
· Swedish and English languages;
· You are familiar with ERP software, IT tools, and advanced Excel functions;


Company
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. Takara Bio Europe AB is located in state-of-the-art facilities in Göteborg, Sweden and has a newly-established GMP laboratory for production of pluripotent stem cell lines. For more information, visit our website: www.takarabio.com


#jobbjustnu Visa mindre

Quality Assurance / Quality Control Manager to Takara Bio Europe AB

Ansök    Jun 28    Takara Bio Europe AB    Mikrobiolog
Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both ... Visa mer
Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. Takara Bio Europe AB is located in state-of-the-art facilities in Göteborg, Sweden and has a newly-established GMP laboratory for production of pluripotent stem cell lines. For more information, visit our website: www.takarabio.comGeneral Duties & ResponsibilitiesExhibit general knowledge of professional ethics, laws and regulations.Maintains broad knowledge of Quality principles and theories including Good Manufacturing Practice (GMP) and ISO 9001/2015.Normally receives assignments in the form of objectives and determines how to use resources to meet deadlines.Provides guidance to colleagues within the extent of established company Quality policies and procedures.Recommends changes to Quality policies and procedures.Other required duties may be assigned.Primary Duties & ResponsibilitiesLead and manage a small QA/QC team, where responsibilities include development of personnel, recruitment, economical follow up and day to day work planning.Maintenance and Development of Quality System processes and procedures (i.e., document management, risk assessment, validation, change control, deviations, corrective action/preventative action, training, quality control, specifications etc.)Review and assessment of batch documentation and QC documentation.Issue, review and approve QC batch related documentation and environmental control documentation.Issue, review and approve Change documentation and Deviations related to the Quality function.Issue, review and approve qualification and validation documentation for QC equipment and systems.Review and approval of qualification and validation documentation for systems, equipment, facilities, manufacturing or testing methods.Review, approval and closure of deviations and non-conformances ensuring adequacy of investigations, root cause and appropriate CAPAs.Review, approval and closure of Change documentation ensuring relevant Quality requirements are met.Plan, perform and report internal and external audits.Take part in regulatory inspections and customer audits.Facilitate or take part in Quality related Risk Assessments.Train employees in GMP, QC, ISO 9001 and other relevant areas.Education/ExperienceMinimum MSc in Pharmacy, Cell Biology, Microbiology or related field.Minimum of 5 years of relevant experience preferably in the biotech/biologics areaExperience of work with ATMP and/or stem cells is an advantage.Proven experience of people’s management from a line function or project management role.Welcome with your application no later than July 27, 2019. We apply continuous evaluation of applicants, therefore this position can be filled before due date.Send your application via https://careers.hrondemand.se/jobs/251105-quality-assurance-quality-control-manager-to-takara-bio-europe-abFor more information, please contact [email protected] +46 765 250 960 Visa mindre

Quality Assurance/Quality Control Associate

Ansök    Nov 25    Takara Bio Europe AB    Biomedicinare
Company Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, includi... Visa mer
Company
Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. Takara Bio Europe AB is located in state-of-the-art facilities in Göteborg, Sweden and has a newly-established GMP laboratory for production of pluripotent stem cell lines. For more information, visit our website: www.takarabio.com


The company is now looking for the following competence.


General Duties & Responsibilities
· Maintains knowledge of Quality principles and theories including Good Manufacturing Practice (GMP) and ISO 9001/2015.
· Maintains knowledge of Quality Control processes and standards.
· Exhibit general knowledge of professional ethics, laws and regulations.
· Relies on instructions and pre-established guidelines to perform the job.
· Normally receives no instructions for routine work, general instructions on new assignments.
· Scheduled work performed during weekends may from time to time be a requirement.
· Other required duties may be assigned.
· Reports to Quality Manager.


Primary Duties & Responsibilities
· Follow company Quality Management System processes and procedures; Good Manufacturing Practice (GMP) and ISO 9001/2015.
· Review and assess manufacturing batch documentation and QC documentation.
· Review, approval and closure of deviations and non-conformances ensuring adequacy of investigations, root cause and appropriate CAPAs.
· Review, approval and closure of Change documentation ensuring relevant Quality requirements are met.
· As needed take part in or act as facilitator for Quality related Risk Assessments.
· Take part in audits and regulatory inspections.
· Maintenance and Development of Quality processes and procedures.
· Perform environmental control of clean room areas in the facility.
· Perform quality control assays of stem cell products.
· Take part in general maintenance activities in the clean room area.
· Issue Change documentation and Deviation documentation related to the Quality Control function.
· Issue qualification and validation documentation for QC equipment, systems and processes.
· Issue, review and assess QC batch related documentation and environmental control documentation.
· Assess and Trend environmental control results.


Education/ Experience Requirement
· MSc in Pharmacy, Cell Biology, Microbiology or related field
· >3 years relevant experience preferably in the biotech/biologics area
· Experience of work with ATMP and/or stem cells is an advantage
· Experience of work in clean room area within GMP is an advantage


We are looking for you who can act in a rapidly developing field, are flexible and are enjoying having a variety of different tasks.


Position
Quality Assurance/Quality Control Associate, full time position.


Welcome with your application no later than December 18, 2020. We apply continuous evaluation of applicants; therefore, this position can be filled before due date. #jobbjustnu


For more information, please contact [email protected]
Phone +46 765 250 972 Visa mindre

Quality Assurance / Quality Control Associate to Takara Bio Europe AB

Ansök    Jun 28    Takara Bio Europe AB    Mikrobiolog
Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both ... Visa mer
Takara Bio Europe AB, formerly Cellartis AB, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. Takara Bio Europe AB is located in state-of-the-art facilities in Göteborg, Sweden and has a newly-established GMP laboratory for production of pluripotent stem cell lines. For more information, visit our website: www.takarabio.comGeneral Duties & ResponsibilitiesExhibit general knowledge of professional ethics, laws and regulations.Maintains knowledge of Quality principles and theories including Good Manufacturing Practice (GMP) and ISO 9001/2015.Relies on instructions and pre-established guidelines to perform the job.Normally receives no instructions for routine work, general instructions on new assignments.Scheduled work performed during weekends may from time to time be a requirement.Other required duties may be assigned.Primary Duties & ResponsibilitiesMaintenance and Development of Quality System processes and procedures (i.e., document management, risk assessment, validation, change control, deviations, corrective action/preventative action, training, quality control, specifications etc.)Follow company Quality Management System processes and procedures.Review and assessment of batch documentation and QC documentation.Responsible for environmental control of clean room areas in the facility.Issue, review and assess QC batch related documentation and environmental control documentation.Assess and Trend environmental control results.Take part in general maintenance activities in the clean room area.Issue Change documentation and Deviations related to the Quality function.Issue of qualification and validation documentation for QC equipment and systems.   Participate in qualification and validation activities for systems, equipment, facilities and manufacturing or testing methods.Review, approval and closure of deviations and non-conformances ensuring adequacy of investigations, root cause and appropriate CAPAs.Review, approval and closure of Change documentation ensuring relevant Quality requirements are met.Take part in audits and regulatory inspections.As needed take part in or act as facilitator for Quality related Risk Assessments.Train employees in GMP, QC and other relevant areas.Education/ Experience Requirement MSc in Pharmacy, Cell Biology, Microbiology or related fieldRelevant experience preferably in the biotech/biologics areaExperience of work with ATMP and/or stem cells is an advantage Welcome with your application no later than July 27, 2019. We apply continuous evaluation of applicants, therefore this position can be filled before due date. Send your application via: https://careers.hrondemand.se/jobs/251134-quality-assurance-quality-control-associate-to-takara-bio-europe-abFor more information, please contact [email protected] +46 765 250 960 Visa mindre