External Manufacturing Specialist, Advanced Therapies

Regeneron Pharmaceuticals•Valley, AL

2d•$62,355 - $110,000•Onsite

About The Position

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.

Requirements

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
Experience in any of the following areas: synthetic-based processes, small molecule synthesis, antibody drug conjugates, fermentation
Knowledge of bulk manufacturing techniques (recommended) – fermentation, chemical synthesis, downstream purification, conjugation and/or formulation
Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines, and EU regulations
Strong interpersonal, written, and oral communication skills
Ability to gain understanding from the instructions provided and work towards goals with minimal supervision
Resiliency and flexibility in the face of a dynamic environment

Responsibilities

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