Senior Manager, External Manufacturing

BioSpace; Town of East Greenbush (NY); On-site; USD 126,000 - 206,000; Full time

Benefits offered by this job

401(k) company match

Health and wellness programs

Job summary

Regeneron is seeking a Senior Manager, External Manufacturing (Operations Lead) to drive day-to-day execution and world-class performance across our CMO network. You will lead a team focused on continuous improvement and technical excellence in a fast-paced manufacturing environment.

The role requires a BS/BA in a scientific or business field with 8 years of related experience, including 5 years in direct cGMP manufacturing operations; MBA is preferred.

Qualifications

• BS/BA in business or scientific discipline with 8 years of related experience, including at least 5 years in direct cGMP manufacturing operations (clinical and/or commercial).
• MBA preferred and experience with supplier management may count towards experience.

Responsibilities

• Ensures product manufacture occurs in compliance with cGMP and applicable regulations.
• Facilitates all External Manufacturing activities at CMO/partner sites: batch scheduling, supply of materials, direct shipment, cycle time tracking, reports and technical expertise.
• Ensures, in collaboration with EM Project Management, timely routing/review of technical transfer activities, validation plans, MRs, SOPs, and other documentation.
• 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 for area.
• Ensures off-site inspections, testing and shipping/packaging is 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 which concern External Manufacturing or associated shipping operations, as required.
• Manages direct reports and/or lead 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.

Skills

cGMP manufacturing

Operations leadership

CMO coordination

Process improvement

Education

BS/BA in business or scientific discipline

MBA preferred

Tools

Regulatory compliance

Job description

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are 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 while leading a team focused on continuous improvement and technical excellence.

When & Where

Location: East Greenbush, NY

Work model: Monday-Friday, 8am-4:30pm

Travel requirement: 25-50%

Discover Your Role

• Ensures product manufacture occurs in compliance with cGMP and applicable regulations.
• Facilitates all External Manufacturing activities at CMO/partner sites: batch scheduling, supply of materials, direct shipment, cycle time tracking, reports and technical expertise.
• Ensures, in collaboration with EM Project Management, timely routing/review of technical transfer activities, validation plans, MRs, SOPs, and other documentation.
• 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 for area.
• Ensures off-site inspections, testing and shipping/packaging is 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 which concern External Manufacturing or associated shipping operations, as required.
• Manages direct reports and/or lead 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.

This Role Requires

BS/BA in business or scientific discipline and 8 years of related experience, including a 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.

We are committed to building a workplace with an inclusive culture. 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.

Benefits and Total Rewards

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• 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

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Recruitment Process

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

Salary Range (annually)

$126,300.00 - $206,100.00