Role Overview
Within 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 Responsibilities
Serving as a Regeneron operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities
Coordinating 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
Enlisting support from others who will provide any required associated reports and technical expertise
Liaising between various departments within Regeneron including, but not limited to, Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners
Leading a sub-team in continuous process improvements, system/equipment implementation and/or strategy development
Supporting all investigations which concern external manufacturing and associated shipping operations
Ensuring product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers and business partners
Performing reviews of pre-production master batch records and executed batch records
Qualifications
Knowledge of external manufacturing from formulation through the final package
Basic knowledge of regulatory compliance inclusive 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 provides team updates
Works towards goals with minimal supervision, gaining understanding from provided instructions
Exhibits 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 stakeholder needs while supporting productive team environments toward a common objective
Experience in collaborating with CMOs/CROs preferred
Competencies in German and/or French (oral and written) preferred
Travels up to 25% (domestic and international), as required
Minimum Qualifications
BS/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 /.
For other countries' specific benefits, please speak to your recruiter.
Equal Opportunity Statement
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.
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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