Principal External Manufacturing Specialist, Gene Therapy

Regeneron Pharmaceuticals, Inc.; New York; Sur place; USD 140 000 - 180 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals, Inc. is seeking a Principal External Manufacturing Specialist to lead day-to-day external manufacturing activities for Gene Therapy programs and to manage relationships with CMOs and partners in Drug Substance and/or Drug Product manufacturing.

The role partners with Quality Control, QA, Supply Chain, and product launch teams to ensure timely transfers, compliant documentation, and optimized cycle times while supporting regulatory filings and strategic initiatives.

Qualifications

• BS/BA in business or scientific discipline with 8+ years of related experience in cGMP manufacturing operations (clinical and/or commercial) or supplier management.
• Experience in Plasmid, Viral Vector, LNP, CAR-T Drug Substance and/or Drug Product is strongly preferred.
• Ability to form strategic partnerships with technical and operational colleagues to collaborate with other departments and contractors.
• Ability to lead continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies.

Responsabilités

• Serving as the operational contact for contract manufacturing and/or partner sites for Drug Substance and/or Drug Product Manufacturing for Gene Therapy programs.
• Facilitating all External Manufacturing activities at contract and/or business partner sites, including scheduling batches, supply of materials, direct shipment of bulk product, tracking cycle times, and providing reports and technical expertise.
• Liaising between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics and CMOs or partners.
• Collaborating with New Product Launch Teams and Life Cycle Management Teams for efficient product launches.
• Overseeing technical transfer activities, validation plans, MR creation, SOPs and documentation for clinical and commercial external manufacturing.

Connaissances

Contract manufacturing

Supplier management

Regulatory filing support

Cross-functional collaboration

Formation

BS/BA in business or scientific discipline

Description du poste

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 a Principal External Manufacturing Specialist position within the Advanced Therapies Team that specializes in Gene Therapy (Viral Vector, LNP, Plasmid, CAR-T) Drug Substance and/or Drug Product Manufacturing. This role strategically manages Regeneron's business relationships and/or facilitates day-to-day operations with Contract Manufacturing Organizations (CMOs) and Partners. Through the External Manufacturing Team, they work to achieve a consistently high level of interaction in order to meet or exceed Regeneron's business needs relating to product quality, availability, and delivery. They ensure that all critical external manufacturing requirements are executed to ensure world-class performance product supply chains.

When & where:

Location: East Greenbush, New York, United States

Work model: Monday-Friday, 8am-4:30pm

Travel: up to 25%

Discover your role:

• Serving as the operational contact for contract manufacturing and/or partner sites concerning day-to-day activities for sites contributing to Drug Substance and/or Drug Product Manufacturing for Gene Therapy programs.
• Facilitating all External Manufacturing activities at contract and/or business partner manufacturing sites, including but not limited to: scheduling batches, supply of materials, direct shipment of bulk product at manufacturing site, tracking and monitoring cycle times and providing 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.
• Collaborating with New Product Launch Teams and Life Cycle Management Teams for efficient product launches of Regeneron's medicines.
• Ensuring, in collaboration with the External Manufacturing Project Management team, the timely routing and review of all technical transfer activities, validation plans, master manufacturing records (MRs), standard operating procedures (SOPs) and other documentation needed to successfully execute required clinical and commercial external manufacturing activities at contractors and/or business partners.
• Supporting and informing strategic initiatives and contract negotiations that drive long-term relationship stability and success.
• Managing quarterly business review meetings or other governance structures with CMOs to drive continuous improvement in joint performance.
• Resolving all supply issues with the CMO/Partner that affect product quality or availability, including evaluating cost/benefit scenarios, making sound recommendations and coordinating internal and external resources to address issues.
• Ensuring off-site inspections, testing and shipping/packaging is done according to guidelines and specifications.
• Ensuring product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers.
• Supporting investigations which concern External Manufacturing or associated shipping operations.
• Providing regulatory filing support to IND, IMPD, BLA, MAA, etc.
• Assisting in developing metrics to analyze department activities, workload and performance.
• Serving as the primary Regeneron technical contact for select contract manufacturing sites concerning day-to-day activities.

This role requires:

• BS/BA in in business or scientific discipline and 8+ years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management, or equivalent combination of education and experience.
• Experience in any of the following areas (strongly preferred): Plasmid, Viral Vector, LNP, CAR-T Drug Substance and/or Drug Product Experience.
• Ability to form strategic partnerships with technical and operational colleagues to effectively collaborate with other departments and contractors.
• Ability to lead continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies for area.

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 rec