Arbetsbeskrivning

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.