External Manufacturing Specialist
About The Position
Regeneron is seeking a Specialist for its Advanced Therapies External Manufacturing team, focusing on synthetic or fermentation-based processes. This role is crucial for overseeing all aspects of contract manufacturing organizations and partners, including day-to-day operations, ensuring timely completion of tasks and documentation, and monitoring cGMP compliance. Regeneron is a leading biotechnology company with over 30 years of experience, known for inventing life-transforming medicines for serious diseases. The company has nine FDA-approved treatments and numerous product candidates developed in-house, targeting various conditions such as eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases, and rare diseases. Regeneron prides itself on an award-winning culture of innovation, recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020.
Requirements
- Experience in any of the following areas: synthetic based processes, small molecule synthesis, antibody drug conjugates, fermentation.
- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines, and EU regulations.
- 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.
- Exhibit a degree of ingenuity, creativity, and resourcefulness in evolving and ambiguous environments.
- Can gain understanding from the instructions provided and work towards goals with minimal supervision.
- Can travel to contract manufacturers or business partners, as required (up to 25%).
- 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 challenging and dynamic environment.
- For a Specialist: BS/BA in business or scientific discipline and 3+ years of related experience in either cGMP manufacturing operations or equivalent combination of education and experience.
- For a Senior Specialist: BS/BA in business or scientific discipline and 5+ years of related experience in either cGMP manufacturing operations or equivalent combination of education and experience.
Nice To Haves
- Knowledge of bulk manufacturing techniques (recommended) – fermentation, chemical synthesis, downstream purification, conjugation and/or formulation.
Responsibilities
- 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 support 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 activities 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.
Benefits
- Inclusive culture
- Comprehensive benefits (vary by location)
- Health and wellness programs (including medical, dental, vision, life, and disability insurance)
- Fitness centers
- 401(k) company match
- Family support benefits
- Equity awards
- Annual bonuses
- Paid time off
- Paid leaves (e.g., military and parental leave)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
