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.
The Manufacturing Technology Manager will lead a group to provide technical support for internal late stage and commercial manufacturing processes. Manage a group responsible for monitoring clinical and commercial manufacturing process with a focus on improving process consistency between manufacturing processes and facilities.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Monitor process operations and procedures to improve manufacturing consistency across process areas.
- Interact with partners and CMOs to ensure comparability of manufacturing operations.
- Assess manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities.
- Provide technical support and training of manufacturing personnel to improve understanding of both cell culture and purification operations across the manufacturing organization.
- Assist in the writing and review of manufacturing records, batch sheets and SOPs.
Provide manufacturing descriptions and technical evaluations for regulatory filings and inspections.
- Gather, trend, and analyze process generated data, create process evaluation reports, process transfer documentation, and process characterization presentation.
- Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
- Ensures all tasks are performed in a manner consistent with safety standards and within cGMP guidelines.
Education and Experience:
BS in Biological Sciences or engineering with 8+ years experience; Masters degree with 5+ years experience or PhD with 2+ years in a scientific discipline preferred.
- Ability to communicate clearly the timelines and important milestones
- Ability to adapt to a quickly changing environment.
- Solid knowledge of cGMP and other applicable regulations.
- Ability to effectively communicate issues and ideas with peers and with management.
- Ability to facilitate meetings with cross functional teams.
- Demonstrated interpersonal, written, and oral communication skills.
- Ability to build effective working relationships throughout the organization.
*Title level (Associate Manager, Manager, or Sr. Manager) 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.
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