Stratacuity
Associate Director CMC, Drug Product
Stratacuity - Boston, Massachusetts, us, 02298
Work at Stratacuity
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Overview
Associate Director CMC, Drug Product 2064423
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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Manufacturing, Science, and Research Industries
Biotechnology Research and Pharmaceutical Manufacturing #J-18808-Ljbffr
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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Manufacturing, Science, and Research Industries
Biotechnology Research and Pharmaceutical Manufacturing #J-18808-Ljbffr