Associate Director CMC, Drug Product
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2025-12-01
Listing for:
Stratacuity: Proven Scientific Placement
Full Time
position Listed on 2025-12-01
Job specializations:
-
Pharmaceutical
-
Healthcare
Job Description & How to Apply Below
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.
Mid-Senior level
Employment typeFull-time
Job functionManufacturing, Science, and Research
IndustriesBiotechnology Research and Pharmaceutical Manufacturing
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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