Principal External Manufacturing Specialist (Drug Product)

About the role

The Senior/Principal External Manufacturing Specialist oversees all aspects of external manufacturing contract manufacturing operations (filling, assembly, packaging) including day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance. Additionally, the role provides guidance to other specialists as well as consults with management on all contract manufacturing operations and GMP compliance issues.

Responsibilities

• Serves as a Regeneron operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities.
• Covers 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.
• 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 monitoring of cGMP compliance at external manufacturing contract manufacturers and business partners.
• Authors documents and procedures.
• Supports audit operations, both internal and external.
• Analyzes data for trends and potential issues.

Requirements

• BS/BA in a scientific discipline and the following 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:
• Senior Specialist - 5+ years
• Principal Specialist - 8+ years

Qualifications

• 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.
• Strong interpersonal, written and oral communication skills.
• Confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.
• Able to impart understanding of provided instructions, develop instructions and sets and works towards goals with minimal supervision.
• A degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments.
• Resilience 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.

Skills

• 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.
• Strong interpersonal, written and oral communication skills.
• Confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.
• Able to impart understanding of provided instructions, develop instructions and sets and works towards goals with minimal supervision.
• A degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments.
• Resilience 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit here.

Pay

$78,700.00 - $150,600.00 annually

Schedule

Monday-Friday, 8am-4:30pm