Principal External Manufacturing Specialist, Gene Therapy

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? Apply now to take your first step towards living the Regeneron Way! 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 recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$94,000.00 - $153,600.00