Program Manager, CMC
Responsibilities of the Program Manager, CMC:
- We are seeking an experienced scientist to build and lead Bolt’s CMC bioassay function.
- Oversee CMC efforts to support drug substance and drug product manufacturing processes
- Optimize manufacturing processes, analytical method development, technology transfer, and shipping/receiving logistics
- Contribute and implement strategies for CMC improvements and business plans
- Work cross functionally with partnered CROs, Clinical and R&D teams
- Support regulatory findings and aid in IND filings.
- Help grow, facilitate, and mentor CMC team as new members join
Requirements of the Program Manager, CMC:
- BS/MS or PhD in life science discipline.
- 5+ years project/program management experience in drug discovery setting, preferably biologics based
- Working knowledge of GMP and CMC guidelines and regulations
- Ability to work cross functionally in a multidisciplinary team
- PMP certification is highly desirable
- Experience with project management software and tools
Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.