Senior External Manufacturing Specialist - DS/FDS/API

We are currently looking to fill a Senior Specialist position within the Bulk External Manufacturing (DS/FDS/API) team. 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 Senior Specialist of External Manufacturing (DS/FDS/API), 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 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.
• 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 (recommended): gene therapy, cell therapy, siRNA therapy, antibody drug conjugates, small molecule synthetic chemistry, plasmid manufacturing
• You have knowledge of bulk manufacturing techniques (recommended) – cell culture, downstream purification, 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 provided instructions 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 challenge and adverse situations

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

Does this sound like you?  Apply now to take your first steps toward living the Regeneron Way!  We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.  We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process.  Please contact us to discuss any accommodations you think you may need.