External Manufacturing Specialist, Advanced Therapies

Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill an External Manufacturing Specialist position within the Advanced Therapies team that specializes in synthetic or fermentation-based processes. This role coordinates 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

Work schedule:

Monday-Friday, 8am-4:30pm

Travel: 25%

• Serving 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 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
• Supporting investigations and associated shipping operations
• Supporting and advising critical initiatives and contracts 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

This role requires:

• BS/BA in scientific field and the following amount of related experience in cGMP manufacturing operations (clinical and/or commercial), or equivalent combination of education and experience, for each level:
• Associate Specialist - 0-2 years
• Specialist - 2+ years
• Level will be determined based on experience

You have experience in any of the following areas: synthetic-based processes, small molecule synthesis, antibody drug conjugates, fermentation

You have knowledge of bulk manufacturing techniques (recommended) - fermentation, chemical synthesis, downstream purification, conjugation and/or formulation

You have basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines, and EU regulations

You have strong interpersonal, written, and oral communication skills

You can gain understanding from the instructions provided and work towards goals with minimal supervision

Shows resiliency and flexibility in the face of a dynamic environment

Does this sound like you?

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 salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

• Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit  For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, man