QC Virology Analyst

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:
Perform routine and non-routine virus and mycoplasma testing (cell-based and molecular biology assays) of manufactured in-process commercial and clinical products according to cGMP and associated standard operating procedures.

Candidate will be responsible for sample chain of custody, sample processing, testing and test data reporting and archiving. Ensure proper level of laboratory supplies and reagents and maintain laboratory in an audit readiness stage and cGMP compliant manner at all times. Review data for conformance to cGMP and specifications and assist with investigation of laboratory deviations. Revise and update standard operation procedures. Display good manufacturing practices and good laboratory practices at all times. Ensure quality and safety of manufactured products as well as safe workplace. Work well in a team environment.

Essential Responsibilities:
• Proficient in cGMP practices in all aspects of laboratory assignments
• Collect, process and report on data for samples associated with in-process testing for the clinical and/or commercial manufacturing facilities
• Apply basic and advanced troubleshooting methods
• Perform cell culture activities to support virus testing
• Serve as SME for an assigned assay
• Assist in data trending, data review, and lab maintenance activities (e.g. cleaning)
• Participate in non-routine projects
• Apply knowledge to assist in investigations and support studies and protocols
• Responsible for collecting, entering data and generating reports from electronic systems
• Follows established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Fosters a positive safety culture in which no one gets hurt.

Knowledge and Skills:
• Some working knowledge in PCR, cell culture, and virus and mycoplasma will be a plus
• Demonstrate excellent organizational skills (multitask)
• Ability to write, read and follow Standard Operating Procedures
• Excellent interpersonal, written and verbal communication skills
• Must be able work independently as well as within a team in a fast pace environment.

Education and Experience:
• BS/BA in Cell Biology, Microbiology, Biochemistry, or related Science
• 1-2 years working in GMP virology or cell culture lab or related experience (with molecular biology knowledge)

Work Environment/Physical Demands:
• Work in office and laboratory environment
• Ability to stand for 8 to 10 hours a day in Lab under biosafety cabinet
• Ability to lift up to 20 lbs
• Work in Labs that requires gowning and no make up or jewelry
• May work in Lab environment which can be a loud environment from different equipment operating
• Work with some hazardous materials and chemicals in addition to viruses and mycoplasma.
• Ability to sit, stand and move within work space for extended periods
• Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling
• Available to work over-time, weekends, and holidays as needed

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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