Principal External Manufacturing Specialist (Advanced Therapies)

Regeneron Pharmaceuticals•Valley, AL

1d•$92,200 - $150,600•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 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.

Requirements

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

Responsibilities

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