Associate Director Quality Control
Regeneron
Full-time
Remote friendly (Rensselaer, NY)
United States
Operations
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Role Summary
Associate Director/Director to lead the Quality Control (QC) Technical Resources Chemistry team, focusing on incoming component testing, functional testing for combination drug products, and raw material testing. Experience in gene therapy or cell therapy is a plus.
Responsibilities
- Leading the qualification and testing strategy for new components, including visual inspection, functional testing, compendial testing, and method validation.
- Managing QC method validation and transfers to/from internal sites, partner companies, and contract manufacturing organizations.
- Providing technical support for filling operations and collaborating with cross-functional teams like Process Sciences, Manufacturing, QC, Stability, and Business Operations.
- Overseeing the development, validation, and transfer of methods, ensuring alignment with project timelines and regulatory requirements.
- Reporting progress to upper management, addressing deficiencies, and ensuring compliance with cGMP regulations and SOPs.
- Supporting investigations of atypical results and overseeing training programs for QC Analysts to maintain a high-performing team.
Qualifications
- BS/BA in Science, Engineering, or related field with experience in the pharmaceutical or biotech industry. Previous management experience is required. Higher level degree preferred. Knowledge and experience in gene therapy or cell therapy is a plus.
- Associate Director – Requires 10+ years relevant experience
- Director – Requires 12+ years relevant experience
Skills
- Creative problem solving, strong communication, and a results-driven mindset
- Ability to work with cross-functional teams to tackle analytical challenges
- Customer-focused approach supporting internal and external partners
- Mentoring and developing teams to achieve their potential
Education
- Bachelor’s degree in Science, Engineering, or related field (higher degree preferred)
Additional Requirements
- Level to be determined based on qualifications relevant to the role