CMC Project Manager (Large Molecule)

Oakland, CA 94607

Posted: 05/07/2025 Employment Type: Contract Job Category: Manufacturing Job Number: 619508 Is job remote?: Yes Country: United States

Job Description

 
  • Start Date: ASAP
  • Location: Remote (PST preferred; bi-weekly calls with CDMO in Asia typically occur in the evening, around 6–7 PM PST)
  • Contract Length: 12+ months, with potential for contract-to-hire
  • Travel: Very rare; may occasionally visit U.S.-based CDMOs
A rapidly growing West Coast biotech company is seeking a contract CMC Project Manager for a 12+ month engagement. The ideal candidate will bring 7+ years of experience in biologics, preferably within a startup or small company setting, and should be familiar with products that are preclinical or not yet in the clinic.

Responsibilities and Qualifications:
  1. Bachelor’s degree with 7–10+ years of relevant experience (Sr. Manager to Associate Director level)
  2. Strong background in biologics development, CMC, and manufacturing with experience at fully outsourced companies
  3. Prior experience with early-phase products (not yet in clinic); candidates with purely commercial product experience will not be a fit
  4. Willingness to provide hands-on support with batch record review, writing protocols/reports, and contributing to IND sections
  5. Preference for those with startup or small company experience—must be flexible, adaptable, and comfortable taking on a range of tasks
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