Director, MSAT-Drug Product (US, UK, Ireland, or Switzerland)

Overview of Role:

We are seeking a highly experienced and strategic Director of MSAT - Drug Product to join the CMC team and lead ongoing process development, technology transfer, process validation, BLA/IND/IMPD authoring and readiness, and agency interaction activities, in preparation for commercialization and incremental clinical/commercial batch production of our main asset. This role will focus on leading a small DP team, DP Tech transfer(s) and on co-authoring the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met. The ideal candidate will bring deep expertise in biologics manufacturing, sterile drug product operations, and regulatory expectations. This role will also contribute strategically and technically to future lifecycle considerations, e.g. productivity improvements, scale-up / scale-out decisions etc.

Role and Responsibilities:

• Lead process development/characterization, tech transfer and process validation for sterile drug product, including oversight of external CDMOs and internal teams.
• Partner with the broader CMC team to implement process, product, and site changes
• Support, with the team, successful execution of clinical and commercial batch manufacturing in alignment with the development and supply timelines.
• Be accountable, with the team, to successfully deliver CMC chapters to regulatory documents
• Actively support dialogue/interaction with regulatory agencies
• Support PLI/PAI preparation and delivery
• Responsible for all stages of Process Validation, including CPV (Continuous Process Verification), in accordance with governing quality system requirements.
• Prioritize post-approval opportunities and develop business cases for further investment/development
• Foster effective communication and collaboration with internal and external stakeholders, including other CMC functions, Regulatory Affairs, Quality Assurance, and CRO’s/CDMO’s
• Collaboratively work across the broader CMC, regulatory and quality departments to deliver desired outcomes
• Collaborate cross-functionally with Regulatory, Quality, Supply Chain, and CMC teams to ensure integrated planning and execution.
• Ensure GMP compliance across all activities.
• Support audits and inspections.
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• MSc degree in Engineering, Biochemistry, Pharmaceutical Sciences, or related field; PhD preferred.
• Minimum of 10+ years of experience in biologics manufacturing, with a focus on sterile drug product and late-phase development.
• Proven track record in BLA preparation, PPQ, and commercial launch.
• Strong knowledge of regulatory expectations (FDA, EMA) for biologics and sterile drug product(s).
• A strong team player and promotor of inclusion and collaboration
• Able to handle multiple projects simultaneously while maintaining high-quality results
• Capable of providing and implementing innovative solutions to unique and pressing situations
• Experience managing CDMO partners and internal cross-functional teams.
• Excellent leadership, communication, and project management skills.