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

Summit Therapeutics•Princeton, NJ

10d

About The Position

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life, increasing potential duration of life, and addressing serious unmet medical needs. The company conducts global clinical studies in oncology and is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland. Summit is seeking an 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 document authoring and readiness, and agency interactions in preparation for commercialization and incremental clinical and commercial batch production. It leads a small drug product team, drug product technology transfers, and co-authors CMC chapters of regulatory submissions while ensuring data integrity and technical compliance. The role also contributes to lifecycle strategy, including productivity improvements and scale-up or scale-out decisions.

Requirements

MSc degree in Engineering, Biochemistry, Pharmaceutical Sciences, or a related field.
Minimum of 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 handle 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 skills.

Nice To Haves

PhD degree.

Responsibilities

Lead process development and characterization, technology transfer, and process validation for sterile drug product, overseeing external CDMOs and internal teams.
Partner with the broader CMC team to implement process, product, and site changes.
Support successful execution of 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.
Oversee 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, CROs, and CDMOs.
Work collaboratively across CMC, regulatory, and quality departments to deliver desired outcomes.
Collaborate with Regulatory, Quality, Supply Chain, and CMC teams to ensure integrated planning and execution.
Ensure GMP compliance across activities.
Support audits and inspections.
Perform other duties as assigned.