The External Manufacturing Specialist coordinates all aspects of 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.
Your day to day could include, but are not limited to, the following:
Education and Experience:
- Serves as a Regeneron operational contact for contract manufacturing and/or business partner sites (CMO's) concerning day-to-day activities.
- Coordinates external manufacturing activities at CMO's including: 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, 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.
- Supports all investigations which concern external manufacturing and associated shipping operations.
- Ensures product integrity and company reputation by monitoring of cGMP compliance at contract manufacturers and business partners.
- Performs reviews of pre-production master batch records and completed batch records.
- Travels up to 25% (domestic and international), as required.
- Specialist: Requires BS/BA in scientific subject area and 2 years of related experience in cGMP manufacturing operations (clinical and/or commercial) or equivalent combination of education and experience.
- Senior Specialist: Requires BS/BA in scientific subject area and 5 years of related experience in cGMP manufacturing operations (clinical and/or commercial) or equivalent combination of education and experience.
Knowledge, Skills and Abilities:
- Knowledge of external manufacturing from formulation through the final package.
- Basic knowledge of regulatory compliance of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
- Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
- Strong interpersonal, written and oral communication skills.
- Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.
- Gains understanding from provided instructions and works towards goals with minimal supervision.
- Exhibits a degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments.
- Shows resiliency and flexibility in the face of challenges and adversarial situations.
- Understands and listens to team members and partners needs while supporting productive team environments toward a common objective.
- Experience in collaborating with CMOs/CROs preferred.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.