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Director, Small Molecule Product Quality Management
Cambridge, MA
The new role of Director, Small Molecule Product Quality Management will lead a talented, global team of scientists and mangers responsible for building quality into processes and products in Biogen Idec’s small molecule product development pipeline. The candidate will develop and implement strategies providing guidance for Product Quality Management through all phases of clinical product development and lifecycle management of commercial products. |
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The candidate in this position will drive functional (quality and cGMP compliance) and cross-functional (Pharmaceutical Development, Analytical Development, QA, QC Supply Management, Contract Manufacturing and Regulatory) collaborations to ensure effective and efficient product quality management support for pharmaceutical development and commercialization of our rapidly growing, diverse small molecule product portfolio.
Qualifications
- Ph.D. in Chemistry, Pharmaceutical Sciences or equivalent with 10+ years of experience in Analytical Development, Process Chemistry or Manufacturing, including 3+ years in Quality or Regulatory departments of Pharmaceutical Company/ies.
- Experience in working with external collaborations for manufacturing, CMC projects and matrix managed projects is desirable. The candidate should possess working knowledge of Quality Assurance, Quality Control, cGMP compliance and regulatory requirements for multiple regulated territories.
- Success factors for this leadership position are ability develop people, change management, ability to drive teamwork for timely decisions in a multi-disciplinary, matrix managed results oriented environment.
- Ph.D in Chemistry, Analytical Chemistry, or MS in Chemical Engineering
Biogen Idec is proud to be an Equal Opportunity Employer.
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