External Manufacturing Specialist

We are currently looking to fill a Specialist position within the Advanced Therapies External Manufacturing team that specializes in synthetic or fermentation-based processes. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. 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. 

As a Specialist of External Manufacturing (Advanced Therapies), a typical day might include the following:

• 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 support 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 activities 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.

This role might be for you if:

• 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 lead continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies for area.

• You have strong interpersonal, written, and oral communication skills.

• You exhibit a degree of ingenuity, creativity, and resourcefulness in evolving and ambiguous environments.

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

• Can travel to contract manufacturers or business partners, as required (up to 25%).

• Are comfortable with leading a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.

• Shows resiliency and flexibility in the face of challenging and dynamic environment

To be considered for a Specialist of External Manufacturing, a BS/BA in business or scientific discipline and 3+ years of related experience in either cGMP manufacturing operations or equivalent combination of education and experience.

To be considered for a Senior Specialist of External Manufacturing, a BS/BA in business or scientific discipline and 5+ years of related experience in either cGMP manufacturing operations or equivalent combination of education and experience.

Level determined based on relevant experience and education.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter