Principal External Manufacturing Specialist
Regeneron
9 hours ago
Remote friendly (East Greenbush, NY)
United States
Operations
Principal External Manufacturing Specialist
Responsibilities
- Oversees external manufacturing contract manufacturing operations (filling, assembly, packaging), including day-to-day activities, ensuring timely completion of associated operations/documentation, and assisting in monitoring cGMP compliance.
- Serves as an operational contact for contract manufacturing and/or business partner sites regarding day-to-day activities.
- Coordinates external manufacturing activities at CMO/business partner sites, including batch scheduling, material supply, direction on bulk/finished product shipment, cycle time tracking/monitoring, and obtaining supporting documentation/reports and technical expertise.
- Coordinates/oversees multiple external manufacturing activities across multiple sites as required.
- Coordinates/oversees DS and FDS manufacturing at the CMO as dictated by the project.
- Liaises with internal departments (Quality Control, Quality Assurance, Supply Chain, Operations/Logistics, Legal, Regulatory, Strategic Sourcing) and external contract manufacturers/business partners.
- Leads sub-teams for continuous process improvements, system/equipment implementation, and/or strategy development.
- Leads or supports investigations involving external manufacturing and associated shipping operations.
- Ensures product integrity and monitors cGMP compliance at external manufacturing sites.
- Reviews pre-production master batch records and executed batch records.
- Authors documents and procedures.
- Supports internal and external audit operations.
- Analyzes data for trends and potential issues.
- Travels 25% (target) or more, domestic and international, as required.
Qualifications
- BS/BA in a scientific discipline.
- 8 years of related experience in cGMP manufacturing operations (clinical and/or commercial external manufacturing), including experience collaborating with CMOs/CROs (or equivalent education/experience).
Skills/Experience (Preferred)
- Knowledge of external manufacturing from formulation through the final package.
- Knowledge of regulatory compliance: cGMP, FDA regulations; familiarity with ICH guidelines and EU regulations.
- Proficiency with Excel, PowerPoint, Visio, Word, Oracle (or similar) and experience in shared work environments.
- Strong interpersonal, written, and oral communication skills.
- Confidence, high emotional IQ, ability to provide team updates.
- Ability to understand and impart instructions, develop instructions/sets, and work toward goals with minimal supervision.
- Ingenuity, creativity, resourcefulness in ambiguous environments; resiliency and flexibility.
- Ability to understand and address stakeholder needs and support productive team environments.
- German and/or French (oral and written) is a plus.
Benefits
- Paid compensation range (annual): $92,200.00 - $150,600.00.
Application Instructions
- Apply now to take your first step toward living the Regeneron Way.
Responsibilities
- Oversees external manufacturing contract manufacturing operations (filling, assembly, packaging), including day-to-day activities, ensuring timely completion of associated operations/documentation, and assisting in monitoring cGMP compliance.
- Serves as an operational contact for contract manufacturing and/or business partner sites regarding day-to-day activities.
- Coordinates external manufacturing activities at CMO/business partner sites, including batch scheduling, material supply, direction on bulk/finished product shipment, cycle time tracking/monitoring, and obtaining supporting documentation/reports and technical expertise.
- Coordinates/oversees multiple external manufacturing activities across multiple sites as required.
- Coordinates/oversees DS and FDS manufacturing at the CMO as dictated by the project.
- Liaises with internal departments (Quality Control, Quality Assurance, Supply Chain, Operations/Logistics, Legal, Regulatory, Strategic Sourcing) and external contract manufacturers/business partners.
- Leads sub-teams for continuous process improvements, system/equipment implementation, and/or strategy development.
- Leads or supports investigations involving external manufacturing and associated shipping operations.
- Ensures product integrity and monitors cGMP compliance at external manufacturing sites.
- Reviews pre-production master batch records and executed batch records.
- Authors documents and procedures.
- Supports internal and external audit operations.
- Analyzes data for trends and potential issues.
- Travels 25% (target) or more, domestic and international, as required.
Qualifications
- BS/BA in a scientific discipline.
- 8 years of related experience in cGMP manufacturing operations (clinical and/or commercial external manufacturing), including experience collaborating with CMOs/CROs (or equivalent education/experience).
Skills/Experience (Preferred)
- Knowledge of external manufacturing from formulation through the final package.
- Knowledge of regulatory compliance: cGMP, FDA regulations; familiarity with ICH guidelines and EU regulations.
- Proficiency with Excel, PowerPoint, Visio, Word, Oracle (or similar) and experience in shared work environments.
- Strong interpersonal, written, and oral communication skills.
- Confidence, high emotional IQ, ability to provide team updates.
- Ability to understand and impart instructions, develop instructions/sets, and work toward goals with minimal supervision.
- Ingenuity, creativity, resourcefulness in ambiguous environments; resiliency and flexibility.
- Ability to understand and address stakeholder needs and support productive team environments.
- German and/or French (oral and written) is a plus.
Benefits
- Paid compensation range (annual): $92,200.00 - $150,600.00.
Application Instructions
- Apply now to take your first step toward living the Regeneron Way.