Role OverviewWithin this role the External Manufacturing Specialist oversees 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.Key ResponsibilitiesServing as a Regeneron operational contact for contract manufacturing and/or business partner sites concerning day-to-day activitiesCoordinating external manufacturing activities at contract and/or business partner sites, including but not limited to:Scheduling of all batchesSupply of materialsProviding direction on shipment of bulk or finished productTracking and monitoring of cycle timesProviding supporting documentation for manufacturing activitiesEnlisting support from others who will provide any required associated reports and technical expertiseLiaising between various departments within Regeneron including, but not limited to, Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partnersLeading a sub‑team in continuous process improvements, system/equipment implementation and/or strategy developmentSupporting all investigations which concern external manufacturing and associated shipping operationsEnsuring product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers and business partnersPerforming reviews of pre‑production master batch records and executed batch recordsQualificationsKnowledge of external manufacturing from formulation through the final packageBasic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulationsProficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environmentsStrong interpersonal, written and oral communication skillsExhibits confidence, has a high emotional IQ, and provides team updatesWorks towards goals with minimal supervision, gaining understanding from provided instructionsExhibits ingenuity, creativity and resourcefulness in evolving and ambiguous environmentsShows resiliency and flexibility in the face of challenges and adversarial situationsUnderstands and listens to team members and stakeholder needs while supporting productive team environments toward a common objectiveExperience in collaborating with CMOs/CROs preferredCompetencies in German and/or French (oral and written) preferredTravels up to 25% (domestic and international), as requiredMinimum QualificationsBS/BA in a scientific discipline and 2 years of related experience in cGMP manufacturing operations (clinical and/or commercial) or equivalent combination of education and experience.Benefits (U.S. Only)Benefits may include health and wellness programs (medical, dental, vision, life and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off and paid leaves (e.g., military and parental leave) for eligible employees at all levels. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.Equal Opportunity StatementRegeneron 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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