Project Manager External Manufacturing

Organization: 
Regeneron Pharmaceuticals, Inc.
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:
Coordinates all aspects of clinical and commercial parenteral drug product filling operations including overseeing day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance at drug product contract manufacturers.

Essential Duties and Responsibilities include, but are not limited to, the following:
- Serves as the primary Regeneron contact for DP contract manufacturing sites concerning day-to-day activities.
- Liaison between Regeneron Quality Control, Quality Assurance, Operations/Logistics Departments and contract manufacturers or business partners.
- Ensure the timely routing and review of all master manufacturing records (MRs), standard operations procedures (SOPs), tech transfer reports, validation master plans, and other documentation related to clinical and commercial drug product manufacturing at contractors and/or business partners.
- Coordinated all filling activities at contract and/or business partner manufacturing sites, including but not limited to: scheduling of all batches, supplying of requested materials, directing shipment of bulk and finished product at manufacturing sites, tracking of outputs and project step completion times, and providing any required associated reports.
- Travel to contract manufacturers or business partners, as required.
- Provide regulatory filing supports (IND, BLA, MAA, etc…)
- Maintain required training status on Regeneron specific work instructions and SOP’s.
- Lead sub-team in continuous process improvements, system implementations and/or strategy development
- Write internal investigation or deviation reports which concern DP Manufacturing or associated shipping operations, if required.
- Support and/or perform internal toxicology and clinical drug product manufacturing.
- Assist in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.

Education and Experience:
- BS/BA in business or scientific discipline with 5+ years of related experience in a pharmaceutical cGMP environment preferred; will substitute relevant industry experience in lieu of educational requirement.

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.

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.

To apply for this position, please CLICK HERE