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About the Role

This role coordinates 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 within the Advanced Therapies team specializing in synthetic or fermentation-based processes.

Responsibilities

• Serve as the operational contact for contract manufacturing and/or partner sites concerning day-to-day activities.
• Coordinate external manufacturing activities at contract and/or business partner sites, including scheduling of all batches, supply of materials, providing direction on shipment of material, tracking and monitoring of cycle times, and providing/enlisting support for required associated reports and technical expertise.
• Function as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners.
• Support investigations and associated shipping operations.
• Support and advise critical initiatives and contracts that drive long-term relationship stability and success.
• Ensure 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.
• Perform reviews of pre-production master batch records and executed batch records.

Requirements

• BS/BA in a scientific field with related experience in cGMP manufacturing operations (clinical and/or commercial), or equivalent combination of education and experience.
• Experience in synthetic-based processes, small molecule synthesis, antibody drug conjugates, or fermentation.
• Knowledge of bulk manufacturing techniques (recommended) including fermentation, chemical synthesis, downstream purification, conjugation and/or formulation.
• Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines, and EU regulations.
• Strong interpersonal, written, and oral communication skills.
• Ability to gain understanding from provided instructions and work towards goals with minimal supervision.
• Resiliency and flexibility in the face of a dynamic environment.

Skills

• cGMP manufacturing operations
• synthetic-based processes
• small molecule synthesis
• antibody drug conjugates
• fermentation
• bulk manufacturing techniques
• chemical synthesis
• downstream purification
• conjugation
• formulation
• regulatory compliance
• cGMP
• FDA regulations
• ICH guidelines
• EU regulations
• interpersonal communication
• written communication
• oral communication

Location

• East Greenbush, New York

Work Type

• On-site

Experience Level

• Associate Specialist – 0-2 years
• Specialist – 2+ years

Education Level

• BS/BA in scientific field

Salary/Compensations

• $62,355.00 - $110,000.00

Benefits

• 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
• Family support benefits

About the Company

• Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
• We are committed to building a workplace with an inclusive culture.
• We believe we do our best work when we are together, and many roles are required to be performed on-site.

Equal Opportunity

• 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.