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

The role

The Director of MSAT-Drug Product will lead process development, technology transfer, and process validation for sterile drug products. This person will lead a small DP team and co-author CMC chapters for regulatory documents to prepare for commercialization.

What you will do

• Lead process development, tech transfer and process validation for sterile drug product
• Oversee external CDMOs and internal teams
• Partner with the broader CMC team to implement process, product, and site changes
• Support execution of clinical and commercial batch manufacturing
• Deliver CMC chapters to regulatory documents
• Support dialogue and interaction with regulatory agencies
• Support PLI/PAI preparation and delivery
• Manage all stages of Process Validation including CPV
• Prioritize post-approval opportunities and develop business cases
• Ensure GMP compliance across all activities

Required qualifications

• MSc degree in Engineering, Biochemistry, Pharmaceutical Sciences, or related field
• Minimum of 10+ years of experience in biologics manufacturing
• 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)
• Experience managing CDMO partners and internal cross-functional teams

Nice to have

• PhD preferred

Benefits

• bonus
• stock
• benefits

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.