Director, MSAT – Sterile Biologics & CMC Strategy

Summit Therapeutics; Princeton (NJ); Sur place; USD 203 000 - 253 000; Plein temps

Résumé du poste

Summit Therapeutics in Princeton, NJ seeks a Director of MSAT - Drug Product to lead ongoing process development, tech transfer, and validation for sterile drug product. You will co-author regulatory CMC sections, oversee DP teams and CDMOs, and ensure data integrity and GMP compliance while aligning with development and commercialization timelines.

The role requires deep biologics manufacturing expertise, 10+ years in late-phase development, and strong regulatory and leadership skills to drive

Qualifications

• MSc degree in Engineering, Biochemistry, Pharmaceutical Sciences or related field; PhD preferred.
• Minimum of 10+ years of experience in biologics manufacturing, with focus on sterile drug product and late-stage development.
• Proven track record in BLA preparation, PPQ, and commercial launch; strong regulatory knowledge (FDA/EMA).

Responsabilités

• Lead process development, tech transfer and validation for sterile drug product.
• Coordinate with CMC team and external CDMOs; ensure data integrity and regulatory compliance.
• Deliver CMC chapters to regulatory documents; support dialogue with regulatory agencies.
• Support PLI/PAI preparation and delivery; ensure GMP compliance and audits.
• Collaborate across Regulatory, Quality, Supply Chain and CMC teams for integrated planning.
• Drive lifecycle improvements and scale-up strategies.

Connaissances

Strategic leadership

Regulatory strategy

Cross-functional leadership

Project management

Formation

MSc or PhD in Engineering/Biochem/Pharma

PhD preferred

Description du poste

Summit Therapeutics in Princeton, NJ seeks a Director of MSAT - Drug Product to lead ongoing process development, tech transfer, and validation for sterile drug product. You will co-author regulatory CMC sections, oversee DP teams and CDMOs, and ensure data integrity and GMP compliance while aligning with development and commercialization timelines.

The role requires deep biologics manufacturing expertise, 10+ years in late-phase development, and strong regulatory and leadership skills to drive