Manager/Senior Manager, CMC, Drug Product (Hiring Immediately) Job at Apex Systems, Boston, MA

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  • Apex Systems
  • Boston, MA

Job Description

Manager/Senior Manager, CMC, Drug Product

Manager/Senior Manager, 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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Job Tags

Full time, Immediate start,

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