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About the Role
Regeneron is seeking a Senior Manager, External Manufacturing (Operations Lead) to drive day-to-day execution, operational readiness, and world-class performance across our Contract Manufacturing Organization (CMO) network. This role involves leading a team focused on continuous improvement and technical excellence to develop life-changing medicines.
Responsibilities
- Ensures product manufacture occurs in compliance with cGMP and applicable regulations.
- Facilitates all External Manufacturing activities at CMO/partner sites, including batch scheduling, supply of materials, direct shipment, cycle time tracking, reports, and technical expertise.
- Ensures timely routing and review of technical transfer activities, validation plans, MRs, SOPs, and other documentation in collaboration with EM Project Management.
- Implements site initiatives in production operation as directed by site management.
- Leads continuous improvements, system implementations, and/or strategy development to reduce cycle times and improve efficiency.
- Ensures off-site inspections, testing, and shipping/packaging are done according to guidelines and specifications.
- Ensures product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers.
- Supports investigations concerning External Manufacturing or associated shipping operations.
- Manages direct reports and/or leads a sub-team in continuous process improvements, system/equipment implementation, and/or strategy development.
- Assists in developing metrics to analyze department activities, workload, and performance.
- Maintains required training status on Regeneron specific work instructions and SOPs.
Requirements
- BS/BA in business or scientific discipline.
- 8 years of related experience.
- Minimum of 5 years of direct cGMP manufacturing operations experience (clinical and/or commercial).
- Remaining years may be satisfied through supplier management experience or equivalent combination of education and experience.
- MBA preferred.
Location
- East Greenbush, NY
Work Type
- On-site
- Monday-Friday, 8am-4:30pm
Experience Level
- Senior Manager
Education Level
- BS/BA
- MBA
Salary/Compensations
- $126,300.00 - $206,100.00
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We believe we do our best work when we are together.
- Many roles are required to be performed on-site.
Equal Opportunity
- 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.