QC Microbiology Analyst

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.

Performs testing to ensure cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.

Essential Duties and Responsibilities include, but are not limited to, the following:
- Reviews and updates SOPs.
- Performs peer review of data.
- Performs laboratory investigation reports.
- Participates in training of other employees.
- Performs microbial identification procedures.
- Maintains laboratory supplies, media, and reagents inventory.
- Participates in the overtime and weekend schedule as required.
- Performs bioburden and endotoxin testing of products and raw materials.
- Performs microbiological testing of in-process and final product materials.
- Performs biological and endotoxin indicator testing used in the validation of manufacturing equipment.
- Updates microbiological environmental monitoring results database and prepares monthly report.
- Performs acceptance testing of commercially prepared microbiological culture media.
- Assists in coordinating equipment maintenance and calibration.
- Uses Laboratory Information Management System (LIMS) for sample and sample test result tracking.
- Performs all duties relevant to the Quality Control Microbiology Technician position as required.

Additional responsibilities for Analysts II-IV include, but are not limited to:
- Increasing involvement in the training of employees.
- Increasing responsibilities for reviewing documents and data.
- Microbiology representation and participation in cross functional site meetings.
- Administration of programs such as gowning, training, ordering, calibration, etc.
- Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.

Education and Experience:
Requires BS/BA in Life Sciences or equivalent along with relative experience, preferably in the pharmaceutical or biotechnology industries. Will substitute relevant work experience in lieu of degree 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.


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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