Principal External Manufacturing Specialist; Advanced Therapies

At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases. We are seeking to fill a Principal External Manufacturing Specialist position within the Bulk External Manufacturing (Advanced Therapies) team that specializes in synthetic chemistry‑based oligonucleotide manufacturing. This role oversees all aspects of contract manufacturing organizations and partners including day‑to‑day operations, ensuring timely completion of associated operations/documentation, and assisting in the monitoring of cGMP compliance.

Location:

East Greenbush, New York, United States
Work model:
Monday-Friday, 8am-4:30pm
Travel: up to 25%

• Serve as the operational contact for contract manufacturing and/or partner sites concerning day‑to‑day activities
• Coordination of external manufacturing activities at contract and/or business partner sites, including but not limited to scheduling of all batches, supply of materials, providing direction on shipment of material, tracking and monitoring of cycle times, providing supporting documentation for manufacturing activities and enlisting support from others who will provide any required associated reports and technical expertise
• Functioning as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners
• Leads a sub‑team in continuous process improvements, system/equipment implementation and/or strategy development
• Supporting investigations which concern external manufacturing and associated shipping operations, as required
• Supporting and informing strategic initiatives and contract negotiations that drive long‑term relationship stability and success
• Ensuring product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers and business partners
• Support tech transfer and/or development work of programs at a CMO to ensure scalability toward GMP manufacturing
• Performing reviews of pre‑production master batch records and executed batch records

• BS/BA in a scientific discipline and 8+ year of experience in cGMP manufacturing operations, or equivalent combination of education and experience
• Experience in any of the following areas (recommended): small molecule synthetic chemistry and/or siRNA therapy
• Knowledge of bulk manufacturing techniques (recommended) chemical synthesis, downstream purification, annealing, lyophilization
• Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines, and EU regulations
• Ability to lead continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies for area
• Strong interpersonal, written, and oral communication skills

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose…