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| Job #03590 |
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| About our client |
| Our client is a rapidly growing biopharmaceutical company headquartered just outside Boston, MA that is focused on the development of therapeutics for diabetes. They have secured over $2M in funding over the past year. The company has an experienced management team, much proof of concept tests and an empowering corporate culture that is focused on the long-term professional development of its employees. |
| Position |
Location |
| Director of CMC |
Massachusetts |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Enable INDs and early clinical work for its lead formulation including contractor selection and supervision
2) Prepare requests for proposals and identify candidate CMC contractors (raw materials, API, formulation, analytics, clinical trial material packaging)
3) Oversee CMC contractors, including monitoring progress according to project timelines, milestones and budgets
4) Act as a scientific liaison and “Man-in-the-Plant” for critical CMC operations
5) Assist in defining CMC plan based on regulatory and clinical requirements
6) Exercise quality assurance responsibilities for outsourced manufacturing (e.g., batch record review, release of clinical supplies)
7) Review, write and compile material for CMC section of IND submission
8) Conduct due diligence audits of CMC contractors
9) Coordinate with regulatory consulting firm |
| Requirements |
1) 10+ years of experience in biotechnology, pharmaceutical or a related industry
2) Direct experience in new insulin product development including CMC, technology transfer and regulatory submission
3) Experience in selecting and overseeing GMP Contract Manufacturing Organizations (CMO)
4) Experience in overseeing stability studies and method development including protein characterization assays
5) In-depth knowledge of CMC Quality Systems including auditing, document development and review, preparation of CMC section of IND |
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