Principal External Manufacturing Specialist (Advanced Therapies)

Regeneron Pharmaceuticals; Valley (AL); In loco; USD 92.000 - 151.000; Tempo pieno

Descrizione del lavoro

Regeneron Pharmaceuticals, East Greenbush, NY, seeks a Principal External Manufacturing Specialist to oversee contract manufacturing partners in synthetic chemistry-based oligonucleotide production. The role ensures timely operations, documentation, and cGMP compliance across sites.

You will coordinate batch scheduling, tech transfer, and continuous improvements while collaborating with QA, QC, supply chain, and vendors.

Competenze

• BS/BA in a scientific discipline and 8+ years of cGMP manufacturing experience.
• Experience with small molecule chemistry or siRNA therapy (preferred).
• Knowledge of regulatory compliance: cGMP, FDA, ICH, EU guidelines.

Mansioni

• Serve as operational contact for contract manufacturing and partner sites.
• Coordinate external manufacturing activities including batch scheduling, materials, and shipment direction.
• Liaise between Regeneron QC/QA, Supply Chain, Operations and CMOs.
• Lead sub-team on continuous process improvements, system implementations, and strategy development.
• Support investigations concerning external manufacturing and shipping operations.
• Support tech transfer and development work at a CMO to ensure GMP scalability.
• Review pre-production master batch records and executed batch records.

Conoscenze

Interpersonal skills

Written communication

Oral communication

Formazione

BS/BA in a scientific discipline

Descrizione del lavoro

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 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.

When & where:

• Location: East Greenbush, New York, United States
• Work model: Monday-Friday, 8am-4:30pm
• Travel: up to 25%

Discover your role:

• 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

This role requires:

• 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

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 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.

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)

$92,200.00 - $150,600.00