Associate Director CMC, Drug Product 2064423

Associate Director CMC, Drug Product

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