Lediga jobb CCRM Nordic AB (svb) i Göteborg

General Description of Role:
The MSAT Director will provide strategic and operational leadership for the function, ensuring the successful transition of process and analytical development efforts into a GMP manufacturing environment. The role focuses on the delivery, optimization, and transfer of robust manufacturing platforms for Advanced Medicinal Therapeutic Products (ATMPs), including an emphasis on both cell and viral vector production and process improvement. The MSAT Director will lead cross-functional teams, drive process innovation, and ensure compliance with regulatory standards.
Tasks and Responsibilities

· Lead the transition of processes and analytics from CMC development to GMP, ensuring consistent product quality, process robustness and alignment with associated acceptance criteria.
· Troubleshoot and resolve technical issues in the transition to GMP manufacture, including root cause analysis and corrective actions.
· Oversee process improvement projects to enhance yield, reduce variability, and improve overall performance; identify opportunities for optimization and efficiency.
· Collaborate with CMC Development colleagues, QC, Operations and other related departments to ensure effective technology transfer.
· Generate and review technical documents (e.g. protocols, SOPs, reports, regulatory submissions) to support CMC technology transfer infrastructure and activities.
· Ensure all activities are conducted in compliance with appropriate level of regulatory rigor and associated frameworks, suitable for the range of development and cGMP operations.
· Act as a senior scientific representative and advocate in meetings with partners, clients, collaborators, and board members.
· Provide technical leadership and guidance to CMC development scientists, ensuring appropriate experimental design, robust method development and effective cross-functional collaboration.
· Oversee recruitment, onboarding, and talent development initiatives to attract, retain, and grow top talent within the CMC Development team.
· Actively participate in external conferences and industry forums to showcase CCRM Nordic’s capabilities and enhance organizational visibility in the ATMP field.
· Contribute strategic input to proposals for new client projects and partnership opportunities.
· Line Management responsibility for selected members of the CMC Development team, providing support with onboarding and in the construction and delivery of personal goals in conjunction with company goals, and aligning with supporting frameworks of employee welfare, inclusive of working environment assessment.
Education and Work Requirements:
· Ph.D. or equivalent in Biochemical engineering, Molecular Biology, Biochemistry, or a related discipline.
· Minimum 5 years’ experience in CMC development/MSAT within the biotechnology or pharmaceutical industry, with a focus on ATMP preferred.
· Strong understanding of process development principles, statistical analysis, and Quality by Design (QbD) concepts.
· Extensive experience with clinically relevant techniques and equipment for the production, purification and formulation of ATMPs
· Extensive experience in technology transfer to/from commercial and research organizations
· Experience with analytical methods for characterization and Quality Control of ATMPs (flow cytometry, qPCR, ELISA, cell-based assays).
· Experience in the use of QMS is essential.
· Working knowledge of regulatory expectations for ATMP production (FDA, EMA, ICH guidelines).
· Excellent leadership and communication skills, with the ability to manage projects and teams in a fast-paced, cross-functional environment.
· Highly organized, detail-oriented, and committed to data integrity and quality compliance. Visa mindre

CQV Lead, CCRM Nordic
Looking for an exciting opportunity to contribute to the development of next-generation cell and gene therapies and to Sweden’s ambition of becoming a leader in Advanced Therapy Medicinal Products (ATMPs)?
Consider applying for the CQV Lead role at CCRM Nordic.

About CCRM Nordic
CCRM Nordic is a national infrastructure for the commercialization of advanced therapy medicinal products (ATMPs). We are a not-for-profit company based in GoCo Health Innovation City, Mölndal, that aims to build process development and GMP ATMP manufacturing capabilities during the coming years. Our vision is to benefit patients by enabling the commercialization of advanced therapies.

Role Summary
CQV Lead
Location: GoCo Health Innovation City, Mölndal
Department: Quality

About the role
As CQV Lead, you will lead the efforts in Commissioning, Qualification and Validation of equipment and facilities, as part of the Quality Assurance (QA) team focusing on maintaining compliance with Good Manufacturing Practices (GMP) regulations for ATMPs, relevant quality standards for process development and company objectives.

As CQV Lead, you are expected to create strategy for CQV, lead the development and execution of processes related to validation and qualification; defining User Requirement Specifications (URS), performing risk analysis, creating validation plans and test protocols, executing test plans, evaluating and reporting test and validation outcome and coverage, in collaboration with the QA manager.

Key responsibilities
General
· Creating strategy for CQV, lead the development and execution of processes related to validation and qualification; defining User Requirement Specifications (URS), performing risk analysis, creating validation plans and test protocols, executing test plans, evaluating and reporting test and validation outcome and coverage, in collaboration with the QA manager.

· Collaborate with and support cross-functional teams to address quality-related issues and provide guidance as applicable.

Commissioning, Qualification and Validation (CQV):
· Develop and implement validation strategies, procedures and documents aligned with regulatory standards within the field, including GMP for ATMPs, ISO 9001, including applicable standards regulating computerized systems (e. g GAMP 5).
· Stay current with evolving industry regulations and standards, ensuring documentation and practices remain compliant.
· Develop and execute commissioning, verification, and qualification test protocols.
· Lead, plan, and coordinate testing activities; document results in accordance with internal protocols.
· Review technical specifications, engineering drawings, and vendor design submissions for accuracy and compliance.
· Analyse test outcomes and prepare comprehensive qualification and validation reports.
Quality assurance:
· Design and implement quality procedures and instructions/SOPs, particularly those related to equipment and computerized system qualification and process validation.
· Support the development and review of User Requirement Specifications (URSs).
· Deliver training across departments as required to promote understanding and adherence to qualification and validation requirements.
· Perform risk assessments and develop mitigation strategies to address quality-related issues and deviations.
· Conduct and review supplier qualification activities to ensure vendor compliance with quality standards.
· Identify and report punch items and deviations; support resolution of technical issues and escalate unresolved concerns.
General:
· Ensure adherence to all company policies and procedures.
· Conduct tasks within the area of responsibility under management oversight, maintaining a compliance mindset.
· Perform additional duties as assigned by management e.g. may lead projects with a limited scope or collaborate on broader projects as applicable.

Education & Experience
· An academic background (M.Sc./B.Sc.) within relevant area, advanced degree preferred.
· 3-5 years of experience working with qualification and validation within the Life science industry.
· Understanding of the V-model (DQ/IQ/OQ/PQ) for process validation and the interpretation of ISO/GMP standards
· Experience in Quality Management Systems /Production/Product/Process Development, preferably within the life science industry
· Experience in a pharmaceutical manufacturing environment, with knowledge of cGMP and facility/equipment/system qualification requirements.
· Experience working with technical specifications and external suppliers.
· Professional proficiency in English is a must; any Swedish proficiency is a benefit.
· Familiarity with regulatory requirements, including EMA, ISO and ICH guidelines pertaining to biologics and ATMPs.
· Ability to work independently and to carry out assignments to completion within parameters of instructions given and according to standard operating procedures (SOPs)
· Strong attention to detail and analytical skills, with the ability to collaborate effectively with cross-functional teams and communicate quality-related issues clearly and concisely.
· Demonstrated ability to interact effectively with cross-functional teams.

How to Apply
Send your CV and a brief cover letter outlining your relevant experience to [email protected]. Applications reviewed on a rolling basis. Visa mindre

CCRM Nordic Process Development Manager & Team Lead

Looking for an exciting opportunity to lead a position at CCRM Nordic contributing to Sweden’s vision of becoming leader in Advanced Therapy Medicinal Products (ATMPs)?
Consider applying for the Process Development Manager & Team Lead role at CCRM Nordic.

About CCRM Nordic

CCRM Nordic is a newly established national infrastructure for commercialization of advanced therapy medicinal products (ATMPs). CCRM Nordic is a not-for-profit company based in GoCo Health Innovation City, Mölndal that aims to build process development and GMP ATMP manufacturing capabilities during the coming years. CCRM Nordic vision is to benefit patients by enabling commercialization of advanced therapies.

Position

Process Development Manager & Team Lead

CCRM Nordic office at GoCo Health Innovation City Mölndal Gothenburg, Sweden

Full time, 100%

About the role

The Team Lead role will act as a Line Manager and steer process development efforts aimed at advancing novel therapeutic approaches, contributing to the optimization and scale-up of manufacturing processes for cell and gene therapy products.

This role will be based in our offices at GoCo Health Innovation City and reports to our Chief Technology Officer.


Main tasks and responsibilities:

The work is performed in cross-functional teams that include Process development, Manufacturing, QA/QC and external suppliers in a highly collaborative, competent, and engaged environment.

· Lead process development activities for the optimization and scale-up of cell and gene therapy manufacturing processes.
· Support and lead the team in the design and execution of experiments to evaluate and improve cell culture processes, gene editing techniques, and/or downstream purification methods.
· Together with the team, develop and implement robust analytical assays to monitor critical quality attributes of therapeutic products.
· Analyze data, troubleshoot technical challenges, and propose innovative solutions to enhance process efficiency and product quality.
· Collaborate with research and development teams to transfer technologies from early-stage development to manufacturing.
· Author and review technical documents, including protocols, reports, and regulatory submissions, to support process development activities.
· Participate in cross-functional project teams to ensure alignment of process development goals with overall project objectives.
· Stay current with advancements in cell and gene therapy technologies, contributing to the continuous improvement of process development strategies.
· Line manage and provide technical guidance to team members, fostering a collaborative and innovative work environment.
· Maintain compliance with regulatory standards and company policies, ensuring the safety and quality of experimental procedures and therapeutic products.


Qualifications/Skills:

· Ph.D. or MSc degree in Bioengineering, Chemical Engineering, Molecular Biology, or a related field.
· Minimum of 5 years of experience in process development within the biotechnology or pharmaceutical industry, with a focus on cell and gene therapy preferred.
· Expertise in mammalian cell culture techniques, media optimization, and bioreactor operations.
· Proficiency in gene editing technologies such as CRISPR/Cas9, lentiviral vectors, or adeno-associated viruses (AAVs).
· Strong understanding of process development principles, statistical analysis, and Quality by Design (QbD) concepts.
· Experience with analytical methods for the characterization of cell-based products, including flow cytometry, qPCR, ELISA, and cell-based assays.
· Excellent communication skills and the ability to effectively collaborate with multidisciplinary teams.
· Proven leadership abilities, with a track record of successfully leading projects and line managing team members.
· Familiarity with regulatory requirements for cell and gene therapy products, including cGMP guidelines and FDA/EMA regulations.
· Highly organized, detail-oriented, and capable of managing multiple projects simultaneously in a fast-paced environment.


Why work at CCRM Nordic

This is an opportunity to make a real impact in the field, shaping the direction of regenerative medicine in the Nordics together with a dedicated enthusiastic team.
You should be based around the Gothenburg region and able to attend our Mölndal office on a regular basis.



Application

Please submit your application as soon as possible to [email protected] as interviews will be held continuously as strong applicants are identified. Please label your application with “Team Lead Process Development”.

Closing date: June 30, 2024. Visa mindre