Director, MSAT-Drug Product (Biologics) – Remote/Hybrid

Summit Therapeutics, Inc.; Princeton (NJ); Hybrid; USD 203,000 - 253,000; Full time

Job summary

Summit Therapeutics Inc. is seeking a highly experienced Director of MSAT - Drug Product to lead process development, tech transfer, validation, and regulatory readiness for commercialization of the company's main asset.

This role will oversee a small DP team and coordinate with external CDMOs to ensure robust manufacturing capabilities. The ideal candidate will bring a deep background in biologics manufacturing, sterile drug product operations, and regulatory expectations, delivering integrated

Qualifications

• 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 promoter 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.

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

Skills

Biologics manufacturing

Regulatory knowledge

Leadership

Cross-functional collaboration

Project management

Education

MSc in Engineering/Biochemistry/Pharmaceutical Sciences

PhD preferred

Tools

CDMO management

Regulatory submissions (BLA)

Job description

Summit Therapeutics Inc. is seeking a highly experienced Director of MSAT - Drug Product to lead process development, tech transfer, validation, and regulatory readiness for commercialization of the company's main asset.

This role will oversee a small DP team and coordinate with external CDMOs to ensure robust manufacturing capabilities. The ideal candidate will bring a deep background in biologics manufacturing, sterile drug product operations, and regulatory expectations, delivering integrated