Regeneron Pharmaceuticals-posted 6 months ago
$145,600 - $237,600/Yr
Full-time • Senior
Rensselaer, NY
5,001-10,000 employees
Chemical Manufacturing

Regeneron is currently seeking an Associate Director/Director for our Quality Control (QC) Technical Resources Chemistry team for in-coming component testing, functional testing for combination drug products and raw material testing. This role will be responsible for bringing new components, determining the qualification and testing strategy, the oversight of the QC method validation of the methods for incoming components including visual inspection, functional testing, compendia testing, and method transfer to or from other internal sites, partners companies, and contract manufacturing companies. Experience in gene therapy and cell therapy is a plus. As an Associate Director, a typical day might include the following: * Support filling operations for any technical support. * QC method validation and transfer processes. * Maintain open communications with scientist including internal, partner and contract manufacturing organizations. * Provide direction to Managers and scientist that support the method development, validation and transfer processes. * Coordinate with members of Process Sciences, Manufacturing, QC, Stability, and Business Ops to provide analytical support. * Oversee Project Management of Method transfer and validations. * Report progress monthly to upper management and reports any deficiencies. * Ensures QC Analysts receive proper training. * Ensures compliance with applicable cGMP regulations and SOPs, and safety standards are maintained. * Oversee investigations atypical and OOS test results as necessary.

  • Support filling operations for any technical support.
  • QC method validation and transfer processes.
  • Maintain open communications with scientist including internal, partner and contract manufacturing organizations.
  • Provide direction to Managers and scientist that support the method development, validation and transfer processes.
  • Coordinate with members of Process Sciences, Manufacturing, QC, Stability, and Business Ops to provide analytical support.
  • Oversee Project Management of Method transfer and validations.
  • Report progress monthly to upper management and reports any deficiencies.
  • Ensures QC Analysts receive proper training.
  • Ensures compliance with applicable cGMP regulations and SOPs, and safety standards are maintained.
  • Oversee investigations atypical and OOS test results as necessary.
  • BS/BA in Science, Engineering, or related field.
  • Experience in the pharmaceutical or biotech industry.
  • Previous management experience required.
  • 10+ years relevant experience for Associate Director position.
  • 12+ years relevant experience for Director position.
  • Experience in gene therapy and cell therapy is a plus.
  • Higher level degree preferred.
  • Health and wellness programs
  • Fitness centers
  • Equity awards
  • Annual bonuses
  • Paid time off for eligible employees at all levels
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