Manager/Senior Manager, CMC, Drug Product
Manager/Senior Manager, CMC, Drug Product 2013639
Location: Boston, MA (Hybrid)
Therapeutic Areas: Undisclosed
Job Overview: Seeking a Manager/Senior Manager CMC to oversee the outsourced process development and cGMP manufacturing campaigns for Drug Product of small molecule drug development programs.
Primary Job Responsibilities:
- Lead and manage multiple concurrent CMC Drug Product projects at CDMOs, including formulation development, process optimization and validation, cGMP manufacturing campaigns, and scale-ups and technology transfer.
- Oversee process scale-up activities to meet forecasted commercial demand as programs progress through development.
- Collaborate with internal and external teams to research, develop, and test processes, analytical methods, and controls for drug product development, and recommend and select vendors for relevant projects.
- PhD or MS in Chemistry, Pharmaceutical Sciences, or Chemical Engineering.
- Possess a minimum of 5 years’ experience in the pharmaceutical industry, with a focus on formulation, process development, and cGMP manufacturing of solid oral dosage drug product.
- Demonstrate experience and proficiency in working, collaborating with, and managing CDMOs.
- Strong understanding of solid oral dosage process technologies and a comprehensive knowledge of cGMP for drug product manufacturing
- Good understanding of cGMP drug product manufacturing guidelines under US and EU regulatory agencies
- Previous experience with writing and supporting CMC regulatory submissions including IND and CTA
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