Director, MSAT-Drug Product
About The Position
Summit Therapeutics Inc. is seeking a highly experienced and strategic Director of MSAT - Drug Product to join its CMC team. The role leads ongoing drug product process development, technology transfer, process validation, regulatory authoring and readiness, and agency interactions in preparation for commercialization and increased clinical and commercial batch production. The Director will lead a small drug product team, manage technology transfers, and co-author CMC chapters for regulatory submissions while ensuring data integrity and technical compliance. The position also contributes strategic and technical input to lifecycle planning, including productivity improvements and scale-up or scale-out decisions. The role focuses on biologics manufacturing and sterile drug product operations, including oversight of external CDMOs and internal teams. The Director works closely with CMC, Regulatory Affairs, Quality Assurance, Supply Chain, and other stakeholders to support clinical and commercial manufacturing, regulatory submissions, inspections, and post-approval development opportunities.
Requirements
- MSc degree in Engineering, Biochemistry, Pharmaceutical Sciences, or a related field.
- At least 10 years of experience in biologics manufacturing, focused on sterile drug product and late-phase development.
- Proven track record in BLA preparation, PPQ, and commercial launch.
- Strong knowledge of FDA and EMA regulatory expectations for biologics and sterile drug products.
- Experience managing CDMO partners and internal cross-functional teams.
- Strong leadership, communication, and project management skills.
- Ability to manage multiple projects simultaneously while maintaining high-quality results.
- Ability to provide and implement innovative solutions to unique and pressing situations.
- Strong teamwork, inclusion, and collaboration.
Nice To Haves
- PhD degree.
Responsibilities
- Lead sterile drug product process development and characterization, technology transfer, and process validation, overseeing external CDMOs and internal teams.
- Partner with the broader CMC team to implement process, product, and site changes.
- Support successful clinical and commercial batch manufacturing in alignment with development and supply timelines.
- Be accountable with the team for delivering CMC chapters for regulatory documents.
- Support dialogue and interactions with regulatory agencies.
- Support PLI/PAI preparation and delivery.
- Manage all stages of Process Validation, including Continuous Process Verification (CPV), in accordance with governing quality system requirements.
- Prioritize post-approval opportunities and develop business cases for further investment or development.
- Foster effective communication and collaboration with internal and external stakeholders, including CMC functions, Regulatory Affairs, Quality Assurance, and CROs/CDMOs.
- Work collaboratively across CMC, regulatory, and quality departments to deliver desired outcomes.
- Coordinate cross-functional planning and execution with Regulatory, Quality, Supply Chain, and CMC teams.
- Ensure GMP compliance across activities.
- Support audits and inspections.
- Perform other duties as assigned.
Benefits
- The total compensation package may include bonus, stock, benefits, and/or other applicable variable compensation.
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What This Job Offers
Job Type
Full-time
Career Level
Director
