Senior Downstream MSAT Lead — Biologics & Tech Transfer

Summit Therapeutics, Inc.; Princeton (NJ); On-site; USD 148,000 - 175,000; Full time

Job summary

Summit Therapeutics Inc. in Princeton, NJ, is seeking a Manager/Senior Manager, Downstream MSAT, to join a late‑stage clinical and commercial environment.

The role focuses on downstream production of biologics, building relationships with CDMOs and internal teams to ensure timely CMC deliverables. You will lead process development, validation, tech transfer, and continuous improvement across DS operations, with strong data analytics, regulatory interaction, and cross‑functional collaboration to

Qualifications

• Experience in MSAT and manufacturing in a biological environment is essential.
• IND/IMPD and regulatory filing experience highly preferred.
• Proven knowledge of downstream operations (Protein A, ion exchange, chromatography).
• Experience with tech transfer and scale‑up across sites is valued.
• Strong communication and collaboration with CDMOs/CMOs.

Responsibilities

• Lead downstream CMC activities: strategy, validation, and continued verification.
• Support phase‑appropriate downstream development and technology transfers.
• Assess process risks and manage deviations and change controls.
• Build relationships with internal teams and external CMOs/CDMOs.
• Assist regulatory filings and provide project updates to leadership.

Skills

JMP data analytics

Communication skills

Attention to detail

Data organization

Interpersonal skills

Work under pressure

Education

Chemical engineering

Biotechnology

Tools

Unicorn

DeltaV

Job description

Summit Therapeutics Inc. in Princeton, NJ, is seeking a Manager/Senior Manager, Downstream MSAT, to join a late‑stage clinical and commercial environment.

The role focuses on downstream production of biologics, building relationships with CDMOs and internal teams to ensure timely CMC deliverables. You will lead process development, validation, tech transfer, and continuous improvement across DS operations, with strong data analytics, regulatory interaction, and cross‑functional collaboration to