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.
Perform method development, optimization and validation for the QC Microbiology group. Provide technical support and guidance for release testing, in-process testing, and microbiological investigations.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Method and equipment validation related to: sterility/bioburden/endotoxin testing, and microbial identifications
- Technical writing including: position papers, validation reports, and microbiological investigations.
- Organism culture, research, and characterization for use in investigations and cleaning development
- Reviews new test procedures and assays
- Evaluate and acquire new methodologies, techniques, and equipment as needed.
- Oversee and support external laboratory testing. Advise in sourcing additional external laboratory testing.
- Set product specifications and alert/action levels
- Participates in technical troubleshooting and problem investigation.
- Review assay, process, and equipment validation reports, as well as, other technical documents for technical correctness and regulatory compliance.
- Coach junior member of the team for good microbiology lab practice and modern aseptic techniques
- Participate in the audit of vendors, external laboratories, business partners, and contracted manufactures as needed
- Support and participate in regulatory inspections as requested
Knowledge and skills:
- Strong background in pharmaceutical microbiology, GMP working experience in QC lab and aseptic techniques are required.
- Strong investigational skill, working knowledge of microbiology assay development and validation are needed.
- Familiarity of isolator technology will be very desirable.
- Basic knowledge of aseptic filling will be a big plus.
- The candidate shall be able to multiple tasking, be result-orientated under a timeline-driven environment and a team player
Education and Experience:
- Requires a PhD in microbiology, or closely related field.
- 5 plus years’ experience in the biopharmaceutical industry 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.
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