Regeneron Pharmaceuticals
Manager External Manufacturing (Drug Product Fill Finish)
Regeneron Pharmaceuticals, East Greenbush, New York, United States, 12061
We are currently looking to fill a Manager External Manufacturing (Drug Product Fill Finish) position. This position strategically leads business relationships and/or facilitates day-to-day operations with Contract Manufacturing Organizations (CMOs) and Partners through the External Manufacturing Team. They will strive to achieve a consistently high level of interaction to meet or exceed Regeneron’s business needs relating to product quality, availability and delivery. They will ensure that all critical external manufacturing requirements are implemented to ensure world-class performance of Industrial Operations & Product Supply (IOPS) product supply chains. The role of the Manager External Manufacturing (Drug Product Fill Finish) is to act as the Relationship Lead with the CMO/Partners or as the Operations Lead within the External Manufacturing Teams.
In this role, a typical day might include the following:
Ensuring that product manufacture occurs in compliance with cGMP and applicable regulations.
Facilitates all External Manufacturing activities at contract and/or business partner manufacturing sites.
Scheduling of all batches, supply of materials, direct shipment of bulk and finished product at manufacturing site.
Tracks and supervises cycle times and providing any required associated reports and technical expertise.
Forms strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and contractors.
Functions as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners.
Collaborates with New Product Launch Teams and Life Cycle Management Teams for efficient product launches of Regeneron’s medicines.
Ensures, in collaboration with the External Manufacturing Project Management team, the timely routing and review of all technical transfer activities.
Collaborates on validation plans, master manufacturing records (MRs), standard operating procedures (SOPs) and other documentation needed to successfully implement required clinical and commercial external manufacturing activities at contractors and/or business partners.
Supports and advises critical initiatives and contract negotiations that drive long-term relationship stability and success.
Implements site initiatives in production operation as advised by site management.
Leads continuous improvements, system implementations and/or strategy development.
The Relationship Leads handle quarterly business review meetings or other governance structures with CMOs to drive continuous improvement.
Resolves all supply issues with the CMO/Partner that affect product quality or availability, including evaluating cost/benefit scenarios and making sound recommendations.
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.
Supports investigations which concern External Manufacturing or associated shipping operations when needed.
May serve as the primary Regeneron technical contact for select contract manufacturing sites concerning day-to-day activities.
This role might be for you if:
Wish to manage direct reports and/or lead a sub-team in continuous improvements, system/equipment implementation and/or strategy development.
Enjoy being the relationship lead and have overall responsibility for RFP’s, project plans, purchase requisitions, etc. associated with contractor operations.
Are driven to assist in developing metrics to analyze department activities, workload and performance.
Willing to travel to contract manufactures or business partners, as the need arises (25%-50%)
Able to maintain training status on Regeneron specific work instructions and SOP’s.
Have experience in providing regulatory filing support to IND, BLA, MAA etc.
To be considered for the Manager role you must have a BS/BA in business or scientific subject area and 7 years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management or equivalent combination of education and experience. Drug Product Fill Finish experience preferred.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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.
Salary Range (annually)
$104,300.00 - $170,100.00
In this role, a typical day might include the following:
Ensuring that product manufacture occurs in compliance with cGMP and applicable regulations.
Facilitates all External Manufacturing activities at contract and/or business partner manufacturing sites.
Scheduling of all batches, supply of materials, direct shipment of bulk and finished product at manufacturing site.
Tracks and supervises cycle times and providing any required associated reports and technical expertise.
Forms strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and contractors.
Functions as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners.
Collaborates with New Product Launch Teams and Life Cycle Management Teams for efficient product launches of Regeneron’s medicines.
Ensures, in collaboration with the External Manufacturing Project Management team, the timely routing and review of all technical transfer activities.
Collaborates on validation plans, master manufacturing records (MRs), standard operating procedures (SOPs) and other documentation needed to successfully implement required clinical and commercial external manufacturing activities at contractors and/or business partners.
Supports and advises critical initiatives and contract negotiations that drive long-term relationship stability and success.
Implements site initiatives in production operation as advised by site management.
Leads continuous improvements, system implementations and/or strategy development.
The Relationship Leads handle quarterly business review meetings or other governance structures with CMOs to drive continuous improvement.
Resolves all supply issues with the CMO/Partner that affect product quality or availability, including evaluating cost/benefit scenarios and making sound recommendations.
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.
Supports investigations which concern External Manufacturing or associated shipping operations when needed.
May serve as the primary Regeneron technical contact for select contract manufacturing sites concerning day-to-day activities.
This role might be for you if:
Wish to manage direct reports and/or lead a sub-team in continuous improvements, system/equipment implementation and/or strategy development.
Enjoy being the relationship lead and have overall responsibility for RFP’s, project plans, purchase requisitions, etc. associated with contractor operations.
Are driven to assist in developing metrics to analyze department activities, workload and performance.
Willing to travel to contract manufactures or business partners, as the need arises (25%-50%)
Able to maintain training status on Regeneron specific work instructions and SOP’s.
Have experience in providing regulatory filing support to IND, BLA, MAA etc.
To be considered for the Manager role you must have a BS/BA in business or scientific subject area and 7 years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management or equivalent combination of education and experience. Drug Product Fill Finish experience preferred.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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.
Salary Range (annually)
$104,300.00 - $170,100.00