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Associate Director, Drug Product Manufacturing

Meet
San Mateo, CA Full Time
POSTED ON 2/27/2025
AVAILABLE BEFORE 5/23/2025

Meet is partnering with a well-funded pre-IPO biotech to hire an Associate Director, Drug Product Manufacturing. This role oversees the drug product manufacturing process at CDMOs for the development and cGMP manufacturing of investigational products. You will provide technical guidance, evaluate process parameters, review reports, and support regulatory filings, ensuring the optimization and troubleshooting of biological processes for clinical development of antibody therapeutics.

Responsibilities :

  • Lead technical oversight and build relationships with CDMOs.
  • Review process specifications, batch data, and technical documents.
  • Participate in CDMO selection, technical risk assessments, and regulatory submissions.
  • Represent CMC Manufacturing in process teams and ensure smooth tech transfer to cGMP manufacturing.

Qualifications :

  • Bachelor’s, MS, or Ph.D. in a relevant field (Chemical Engineering, Biochemistry, etc.).
  • 6 years of biopharmaceutical industry experience, including vendor management in cGMP.
  • Hands-on experience with unit operations and DP filling processes.
  • Strong knowledge of FDA cGMP regulations and regulatory submissions.
  • Excellent communication, project management, and organizational skills.
  • Ability to work independently in a fast-paced environment, with some travel required.
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