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Associate Director CMC, Drug Product

Job in Boston, Suffolk County, Massachusetts, 02298, USA
Listing for: Apex Systems
Full Time position
Listed on 2025-04-23
Job specializations:
  • Healthcare
  • Pharmaceutical
Job Description & How to Apply Below

Associate Director CMC, Drug Product 2064423

Science:
Small Molecule Therapeutics

Job Overview:
Seeking a Manager/Senior Manager, CMC, Drug Product to oversee small molecule drug development, manage outsourced development activities, and handle cGMP manufacturing campaigns.

Primary Job Responsibilities:

  • Lead CMC drug product projects, including development, optimization, and manufacturing at CDMOs.
  • Direct process scale-ups and technology transfers ahead of commercial demand.
  • Collaborate on refining development and testing methods with internal and external experts.
  • Draft critical CMC drug product sections for regulatory submissions, ensuring compliance.

Primary Job Requirements:

  • PhD or MSc with extensive experience in chemistry or pharmaceutical sciences.
  • 5+ years in pharma with expertise in solid dosage form development and cGMP manufacturing.
  • Familiar with US, Canadian, and EU regulatory requirements; experienced in regulatory filings.
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Position Requirements
10+ Years work experience
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