External Manufacturing Specialist, Advanced Therapies

About the role

This position 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. This role specializes in synthetic or fermentation-based processes.

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 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
• Supporting investigations and associated shipping operations
• Supporting and advising critical initiatives and contracts 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

Qualifications

• BS/BA in scientific field
• Associate Specialist – 0-2 years of related experience in cGMP manufacturing operations (clinical and/or commercial), or equivalent combination of education and experience
• Specialist – 2+ years of related experience in cGMP manufacturing operations (clinical and/or commercial), or equivalent combination of education and experience
• Level will be determined based on experience
• Experience in any of the following areas: synthetic-based processes, small molecule synthesis, antibody drug conjugates, fermentation
• Knowledge of bulk manufacturing techniques (recommended) – 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
• Can gain understanding from the instructions provided and work towards goals with minimal supervision
• Shows resiliency and flexibility in the face of a dynamic environment

Pay & Schedule

• Location: East Greenbush, New York
• Work schedule: Monday-Friday, 8am-4:30pm
• Travel: 25%
• Salary range: $62,355.00 - $110,000.00 annually