Associate Director Quality Control - Regeneron : Job Details

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Regeneron is seeking an Associate Director/Director for our Quality Control (QC) Technical Resources Chemistry team, focusing on in-coming component testing, functional testing for drug products, and raw material testing. Responsibilities include qualification and testing strategy development, overseeing QC method validation for incoming components, visual inspection, functional testing, compendia testing, and method transfer between internal sites, partners, and contract manufacturers. Experience in gene and cell therapy is a plus.

• Support filling operations with technical expertise.
• Manage QC method validation and transfer processes.
• Maintain communication with scientists, partners, and manufacturing organizations.
• Provide guidance to managers and scientists on method development, validation, and transfer.
• Coordinate analytical support with Process Sciences, Manufacturing, QC, Stability, and Business Operations.
• Oversee project management of method transfer and validation activities.
• Report progress to upper management monthly and address deficiencies.
• Ensure QC analysts receive proper training.
• Maintain compliance with cGMP regulations, SOPs, and safety standards.
• Oversee investigations of atypical and OOS test results.

• Looking to join a diverse, growth-oriented team.
• Creative problem solver, effective communicator, goal-oriented.
• Experience working with cross-functional teams in analytical development and support.
• Customer service focused for internal and external partners.

BSc/BA in Science, Engineering, or related field with pharma or biotech industry experience. Management experience required. Higher degrees preferred.

• Associate Director: 10+ years relevant experience.
• Director: 12+ years relevant experience.

If this describes you, apply now to join Regeneron's inclusive culture with comprehensive benefits. We are an equal opportunity employer committed to diversity and inclusion.