Associate Director, QC Biological Testing

Organization: 
Regeneron Pharmaceuticals
Job Location: 
Rensselaer, NY
Job Description: 

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.

Summary:
- Provides oversight of the Cell Biology Laboratory. Employee is technically responsible for all biological aspects of QC testing.

Essential Duties and Responsibilities:
- Provide work planning and technical guidance to lab personnel and technical review.
- Data analysis and review and release of product.
- Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory.
- Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed.
- Characterization/optimization/validation of cell-based potency assays, binding assays, contaminant assays and media lot testing.
- QC liaison to External Manufacturing regarding transfer of identification assay to fillers and the performance of bioburden and sterility testing at the fillers.
- Author technical and regulatory reports, SOPs, TCRs, CAPAs and MCs.
- Qualify equipment as needed.
- Perform software validations as needed.
- Perform investigations for OOS deviations.
- Co-manage quality system for monitoring OOS results, atypical results and invalid tests.
- Release intermediate and final product.
- Provide information to investigators as needed during regulatory audits.
- Ensure quality and regulatory compliance.
- Prepares annual employee evaluations and recommendations.
- Provide support to the Scientist performing assay development and validation.
- Provide operational support to the Supervisor as needed.

Education and Experience:
- Advanced level degree preferred along with minimum 15 years of supervisory and/or leadership experience in a related field.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.

To all recruitment agencies:
Regeneron is using the agency management company, Candex - www.candex.com. Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means.

Regeneron is an equal opportunity employer and is an affirmative action employer.

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