Analytical Specialist

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:
Support the Manufacturing, Process Sciences (PS) and Quality Control (QC) departments through the development, optimization, troubleshooting, validation, transfer and application of analytical test procedures, and clinical product testing as needed.

Essential Duties and Responsibilities may include, but are not limited to, the following:
• Establish, develop, and/or optimize analytical methodology to test the identity, strength, purity, potency and stability of protein products (in-process and final).
• Establish, develop, and/or optimize analytical methodology to test the identity and concentration of impurities (product-related and process-related).
• Establish, develop, and/or optimize analytical methodology to test the identity and purity of raw materials.
• Develop and write protocols for assay qualification/validation studies and analytical SOPs for product testing.
• Perform assay qualification/validation experiments.
• Transfer new or improved control test procedures to customer groups.
• Troubleshoot established test methods used in development and release testing. Provide analytical support in troubleshooting process and formulation problems.
• Perform routine stability and release chemistry and biochemistry testing for pre-clinical and early clinical phase programs
• Assist in the analysis of samples generated from lab scale process studies.
• Assist in product failure or customer complaint investigations
• Assist QC Release group with overflow routine testing
• Tabulate results and write summary reports of assay development and validation studies.
• Present findings at group and possibly at interdepartmental meetings.
• Maintain lab supplies and equipment for GMP compliance.
• Produce and maintain accurate records.
• Write departmental SOPs and provides drafts of proposed test methods to QC.
• Train lower level group members.

Education and Experience:
• Requires BS/BA in Chemistry, Biology or related field for level I; progressive experience working in a cGMP pharmaceutical environment required for subsequent levels.
• May substitute relevant experience in lieu of educational requirement.

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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