Manager External Manufacturing

Location
Rensselaer, NY, United States
Posted
Jan 16, 2021
Ref
22888BR
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a Manager- External Manufacturing role for bulk (API) external manufacturing. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Managers, strategically manage business relationships and/or facilitates day-to-day operations with Contract Manufacturing Organizations (CMOs) and Partners through the Drug Substance (DS) and Formulated Drug Substance (FDS) Manufacturing Team to achieve a consistently high level of interaction in order to meet or exceed Regeneron's business needs relating to product quality, availability and delivery.

As a Manager -External Manufacturing, a typical day might include the following:
  • Ensuring that all critical external manufacturing requirements are executed to ensure world-class performance of Industrial Operations & Product Supply (IOPS) product supply chains.
  • Acting as the Relationship Lead with the CMO/Partners or as the Operations Lead within the bulk external manufacturing Teams.
  • Ensuring that product manufacture occurs in compliance with cGMP and applicable regulations.
  • Facilitating all bulk manufacturing at CMO/Partners sites, including but not limited to: scheduling of all batches, supply of materials, direct shipment working cell bank and starting materials to the respective manufacturing site, tracking and monitoring cycle times and providing any required associated reports and technical expertise.
  • Functioning as a liaison between Regeneron Quality Control, Manufacturing, Quality Assurance, Supply Chain, Operations/Logistics Departments and CMO/Partners.
  • Collaborating with New Product Launch Teams and Life Cycle Management Teams for efficient product launches of Regeneron's medicines.
  • Ensuring, in collaboration with the DS Manufacturing Sciences & Technology (MSAT) team, the timely routing and review of all technical transfer activities, validation plans, master manufacturing records (MRs), standard operating procedures (SOPs) and other documentation needed to successfully execute required clinical and commercial bulk manufacturing activities at contractors and/or business partners.
  • Resolving all supply issues with the CMO/Partner that affect product quality or availability, including evaluating cost/benefit scenarios, making sound recommendations and coordinating internal and external resources to address issues.
  • Supporting investigations which concern Bulk External Manufacturing or associated shipping operations, as the need arises.
  • May manage direct reports and/or lead a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
  • Serving as the primary Regeneron technical contact for select bulk contract manufacturing sites concerning day-to-day activities.
This role might be for you if you:
  • Can form strategic partnerships with technical and operational colleagues to effectively collaborate with other departments and contractors.
  • Can support and advise critical initiatives and contract negotiations that drive long-term relationship stability and success.
  • Look to implement site initiatives in production operation as advised by site management.
  • Are familiar with antibody manufacturing processes.
  • Have knowledge of Gene Therapy manufacturing processes.
  • Seek to lead continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies for area.
  • Are experienced in providing regulatory filing support to IND, BLA, MAA, etc.
  • Are driven to assist in developing metrics to analyze department activities, workload and performance.
  • Will maintain required training status on Regeneron specific work instructions and SOPs.
  • Wish to manage direct report and/or lead a sub-team
  • Work to ensure off-site inspections, testing and shipping is done according to guidelines and specifications.
  • As Relationship Lead have overall responsibility for RFPs, project plans, purchase requisitions, etc. associated with contractor operations.
  • Willing to travel to contract manufacturers or business partners, as required (25-50%).
To be considered for the Manager External Manufacturing role you must have the following; BS/BA in a business or scientific discipline, an MBA is preferred with related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management; 6 years at Associate Manager, 7 years at Manager level and 8 years at Senior Manager Level or equivalent combination of education and experience. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.