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External Manufacturing Specialist

Job Description

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Within this role you will be responsible for all aspects of partner and contract manufacturing bulk operations (filling, assembly, packaging) including day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance.

As an External Manufacturing Specialist a typical day might include, but is not limited to, the following:

  • Acting as the Regeneron operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities

  • Tracking and supervising cycle times and providing supporting documentation for manufacturing activities

  • Collaborating closely with various departments such as Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners

  • Supporting investigations which concern external manufacturing and associating shipping operations

  • Ensuring product integrity and company reputation by assisting in the monitoring of cGMP compliance

  • Performing reviews of pre-production master batch records and executed batch abstracts

  • Travel up to 25% (domestic and international), as required

This role might be for you if:

  • You have proficient skills in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments

  • You show strong interpersonal, written and oral communication skills

  • You demonstrate resilience and flexibility in the face of challenges and adversarial situations

  • You have capability to understand and listen to team members and partners needs while supporting productive team environments toward a common objective

To be considered for this role you should have a BS/BA in scientific discipline and 2 years of related experience in cGMP manufacturing operations (clinical and/or commercial External Manufacturing) or equivalent combination of education and experience.


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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.