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US-MA-Lexington: Chemistry Manufacturing and Control Director

Date: 08-Mar-2011
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Director, CMC (Chemistry Manufacturing and Control)

Seeking a Director CMC (Chemistry Manufacturing and Control), Pharmaceutical Sciences. Reporting to the Vice President, Drug Development, the chemistry manufacturing & control (CMC) director will be responsible for the creation of the CMC strategy for a diverse portfolio of molecules, ensuring test article and study drug are developed and manufactured on-time, within budget & scope. The CMC director will be responsible for the global outsourcing strategy. Applicants must possess a formulations background.

Responsibilities include, but are not limited to:

Validation, technology transfer and resolution of technical issues during CGMP manufacturing;

Managing relationships with CMOs and collaboration partners;

Reviewing and approving regulatory filings, specifications, change controls and Master Batch records;

Assisting with CRO selection and contract negotiations and budgeting.

Requirements:

This position requires a Ph.D. in Chemistry related sciences, e.g., Organic Synthetic Chemistry, Medicinal Chemistry, Analytical Chemistry, Pharmaceutical Sciences or Engineering, with 10+ years experience in cGMP related CMC drug development or manufacturing.

Candidates must possess experience in the preparation of CMC regulatory documentation. He/She must show demonstrated leadership experience in CMC: preferably in more than one related CMC area, and drug development experience with many molecules of varying degrees of complexity. Requires experience in development and validation cGMP chemical manufacture and cGLP analyses.

Ideal candidates will possess demonstrated project management skills, as well as strong teamwork/interpersonal skills and a demonstrated ability to influence at many levels across many disciplines, both externally and internally.

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BioTech FYI Center
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