External Manufacturing Specialist (Drug Product)

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

About the Role

Serves as a Regeneron operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities. The External Manufacturing Specialist oversees all aspects of external manufacturing contract manufacturing operations (filling, assembly, packaging), including ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance.

Responsibilities

• Coordinates 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 bulk or finished product, 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.
• Coordinates/oversees multiple external manufacturing activities at multiple sites, as required.
• Liaises between various departments within Regeneron including, but not limited to Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments, Legal, Regulatory, Strategic Sourcing, and contract manufacturers or business partners.
• Leads sub-teams in continuous process improvements, system/equipment implementation, and/or strategy development.
• Leads or supports all investigations which concern external manufacturing and associated shipping operations.
• Ensures product integrity and company reputation by monitoring cGMP compliance at external manufacturing contract manufacturers and business partners.
• Performs reviews of pre-production master batch records and executed batch records.
• Authors documents and procedures.
• Supports audit operations, both internal and external.
• Analyzes data for trends and potential issues.
• Travels 25% (target) or more (domestic and international), as required.

Requirements

• BS/BA in a scientific discipline.
• Years of experience in cGMP manufacturing operations (clinical and/or commercial external manufacturing), including experience collaborating with CMOs/CROs, or equivalent combination of education and experience, for each level:
  • Associate Specialist: 0-2+ years
  • Specialist: 2+ years
• Knowledge of external manufacturing from formulation through the final package.
• Knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines, and EU regulations.
• Proficient in Excel, PowerPoint, Visio, Word, Oracle, etc., in addition to experience working within shared work environments.

Skills

• Strong interpersonal, written, and oral communication skills.
• Confidence, high emotional IQ, and ability to provide team updates effectively.
• Ability to impart understanding of provided instructions, develop instructions, and set and work towards goals with minimal supervision.
• A degree of ingenuity, creativity, and resourcefulness in evolving and ambiguous environments.
• Resiliency and flexibility in the face of challenges and adversarial situations.
• Understanding and listening to team members' and stakeholders' needs while supporting productive team environments toward a common objective.

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
• Family support benefits

Pay

Salary Range (annually): $62,355.00 - $110,000.00