Our client is seeking a Head of CMC Operations in Boston, MA!
Our client is a biotechnology company which develops medicines to combat serious diseases. The company focuses on the immune, gastrointestinal, and central nervous systems as well as utilizing a cross-disciplinary approach for discovering/developing medicines with platforms in emerging disciplines. They hold an excellent employee-retention rate and offers competitive salaries and bonus structures. And this position allows for expansion and upward mobility in the future.
The Head of CMC Operations will be a key member of the management team overseeing CMC activities which will be primarily executed through external vendors. The candidate be a strong relationship manager, a strategic thinker, and have an entrepreneurial mindset.
- Oversee API and drug product production for clinical trials including scale up and implementation of relevant analytical methods
- Lead contract manufacturing organization selection and contract negotiations
- Support in troubleshooting, deviation management, risk assessment and other activities related to release of cGMP material
- Support regulatory efforts for Pre-IND and IND submissions related to CMC
- Work closely with the company’s Project Management and Finance teams including helping to prepare budgets related to CMC activities
- An undergraduate degree in science is required; PhD is preferred
- Minimum of 8-10 years managing CMC activities
- Experience with small molecule and antibody therapies is required
- Experience selecting and managing external vendors
- Strong verbal & written communication skills
- Experience in a small virtual company environment is helpful
- Experience with writing the CMC portion of INDs is preferred
Qualified Candidates Please Send us your CV
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