External Manufacturing Specialist

Regeneron Pharmaceuticals • Valley, AL

19h • $67,400 - $128,700 • Onsite

About The Position

This Specialist position is within the Advanced Therapies External Manufacturing team, focusing on synthetic or fermentation-based processes. Regeneron is a leading biotechnology company that successfully manufactures a range of biopharmaceuticals globally, including approved therapeutic proteins and those in clinical studies. The role involves overseeing all aspects of contract manufacturing organizations and partners, from day-to-day operations and ensuring timely completion of documentation to assisting in monitoring cGMP compliance. Regeneron is known for its inclusive culture, comprehensive benefits, and award-winning innovation, having developed nine FDA-approved treatments and numerous product candidates. The company's medicines target various serious diseases, including eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases, and rare diseases.

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.
• 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.
• Exhibit a degree of ingenuity, creativity, and resourcefulness in evolving and ambiguous environments.
• Ability to gain understanding from the instructions provided and work towards goals with minimal supervision.
• Ability to 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.
• 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 Specialist level).

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

• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees