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.
Responsible for QC microbiological aspects of cGMP compliance and testing.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Responsible for QC microbiological aspects of cGMP compliance and testing.
• Perform microbiological validations as needed for finished product and in process controls and buffers.
• Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed.
• Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.
• Participate in cleaning and process validation activities involving microbiology as needed.
• Participate in the investigation of microbiological product OOS results and DNF as needed.
• Contribute to the preparation of technical proposals, amendments, reports and memoranda.
• Contribute toward creating and revising microbiological SOPs.
• Assist in scheduling of M/C and post incursion monitoring procedures with follow-up responsibility to provide test results.
• Assist in the review of EM and product release data.
Education and Experience:
• Requires BS/BA in Biochemistry, Chemistry, Biology or related field with 5+ years of relevant experience, preferably in the pharmaceutical or biotechnology industries. Must have experience with pharmaceutical documentation practices and demonstrated leadership skills.
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.
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.
To apply for this position, please CLICK HERE