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.
Supports Commercial Pack & Label management functions/special projects.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Coordinates all aspects of labeling and packaging for all commercial programs, including Purchase Orders of production and components, Quality System associated documentation, and/or any pertinent documents
- Ensures that product manufacture occurs in compliance with cGMP and applicable regulations.
- Forms relationships with technical and operational colleagues to effectively collaborate with other departments and contractors.
- Support Manager of Commercial Pack & Label, as needed.
- Participates in continuous improvements, system implementations and/or to reduce cycle times and improve efficiencies for area.
- Ensures off-site inspections, testing, and shipping/packaging is done according to guidelines and specifications.
- Provide regulatory filing support to IND, BLA, MAA, etc.
- Maintain metrics to analyze department activities, workload and performance.
- Travel extensively (75%) to contractors for overview of operations as needed.
Knowledge and Skills:
- Strong attention to details
- Excellent at building relationships
- Good knowledge of word processing, Outlook, spreadsheet, and database management software;
- High level of emotional maturity and self-confidence;
- Good communication skills
Education and Experience:
- BS/BA degree mandatory, in administration or life science
- 5years experience in dealing with Contract Manufacturers or Suppliers or transferable experience; OPM/MRP experience desired.
- Title level (Associate, Mid-level, or Sr.) will be determined based on skills and experience.
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