QC Reference Standard Analyst III-IV

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

If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.

Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia.

Summary:
Summary: Performs a variety of activities to administer the reference standard and stability program and manage data generated in support of the company's quality program.

Essential Duties and Responsibilities include, but are not limited to, the following:
- Reference Standard Program Management
- Implement laboratory reference standards for each product candidate, including material selection and preparation;
- Ensure adequate qualification and stability testing are performed for laboratory reference standards;
- Review analytical data for qualification and stability data for laboratory reference standards;
- Trend reference standard data to ensure continued integrity of laboratory reference standards; and author appropriate sections of regulatory documents relating to reference standard program.
- Provide Reference Standards data to Regulatory;
- May assist QC Stability Program in data review and other program activities, as required
- May review analytical data and compiles into a central database;
- Ship References Standards to external contractors, fillers, partners, and Tarrytown as required.

Education and Experience:
- Requires BS/BA in Life Sciences or related field; may substitute relevant experience for education, along with 2 years of administrative experience desired. 3-5 years experience in pharmaceutical industry and drug stability studies preferred.

We offer a competitive compensation and benefits package including stock incentives, 401k with company match, as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.

EOE/M/F/D/V

Disclaimer:
Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. 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. Moving forward, Regeneron is using the agency management company, Candex - www.candex.com

ARCALYST, EYLEA, and ZALTRAP are trademarks of Regeneron Pharmaceuticals, Inc.

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