Senior Principal Engineer/associate Director, Drug Product Msat

Summit Therapeutics

Princeton, NJ, United States
Base: $180,000 - $195,000 usd; bonus/equity: not s...
On-site
Sterile drug product process development
Late-phase clinical manufacturing experience
Technology transfer across multiple sites
Summit Therapeutics is seeking a Senior Principal Engineer/Associate Director of MSAT - Drug Product to lead drug product process development, technology transfer, and regulatory submissions for their oncology-focused therapies. The ideal candidate will have extensive experience in biologics manufacturing, particularly in sterile drug product operations, and a strong understanding of regulatory expectations

Job Summary

  • Summit Therapeutics is seeking a strategic leader to drive the commercialization of its oncology assets through advanced drug product process development and technology transfer.
  • The role requires extensive expertise in sterile drug product operations, including leading process validation, regulatory filings, and agency interactions for Phase 3 studies.
  • Candidates must possess a track record of managing complex manufacturing changes and ensuring GMP compliance while collaborating with cross-functional teams and external partners.

Matching Summary

Match Score: 88

Summit Therapeutics is seeking a Senior Principal Engineer/Associate Director of MSAT - Drug Product to lead drug product process development, technology transfer, and regulatory submissions for their oncology-focused therapies. The ideal candidate will have extensive experience in biologics manufacturing, particularly in sterile drug product operations, and a strong understanding of regulatory expectations.

Salary

Base: $180,000 - $195,000 USD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Sterile drug product process development
  • Late-phase clinical manufacturing experience
  • Technology transfer across multiple sites
  • BLA/MAA Module 3 authorship
  • GMP compliance and quality systems
  • CDMO management and oversight

Nice-to-have

  • Data analytics with JMP platform
  • AI-based data organization tools
  • Continuous Process Verification planning
  • Strong communication and influence skills
  • Experience with mAbs biologics

Key Requirements

  • Bachelor's degree in chemical engineering or related field
  • 10+ years of life sciences industry experience
  • Advanced degree (Masters or PhD) preferred
  • Experience with IND/IMPD and BLA/MAA authorship
  • Proven ability to work under pressure with tight deadlines

Work Rights

Not specified

Tailored Resume

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