Manager Fill Finish Manufacturing

Location
Rensselaer, NY, United States
Posted
Jun 05, 2021
Ref
24930BR
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a Manager Fill Finish Manufacturing position with a 1st shift, Monday-Friday, 8:00 a.m-4:30 p.m. schedule. Regeneron optimally manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. The Fill/Finish Manufacturing Manager will serve as a process professional in equipment design and selection, support process development for internal operations, and will be hands-on solving issues during technology transfer and cGMP start-up for Regeneron internal operations.
As a Manager Fill Finish Manufacturing, a typical day might include the following:
  • Acts as fill / finish SME, with a focus on assembly and packaging operations. Supports Engineering, Combination Products, Validation and Quality Assurance (tech transfer studies / tech transfer, investigations, innovative technology adoption)
  • Drives innovation in the area of device assembly, labelling and packaging by keeping tabs on the latest technological advancements and ensuring a creative environment and implementation along the business case and Regeneron's needs
  • Guides and consults on validation and technical transfer activities involving fill / finish equipment and processes internally
  • Supports equipment / new technology design, install and qualification
  • Collaborate with other departments such as Facilities, Process Development, Process Analytical Sciences, Combination Products, Regulatory, Quality Assurance and Quality Control
  • Builds capability / establishes a team - responsible for providing the technical content of the training program for operations and operations support teams
  • Provides leadership, vision and management to the manufacturing team
  • Develops and recommends manufacturing policies, schedules, procedures and programs
  • Recommends capital expenditures and aids in the realization of capital projects
  • Prepares and coordinates expense and capital budgets
  • Represents manufacturing during regulatory and client audits
  • Develops department goals, objectives and metrics
  • Works closely with staff to develop and handle individual goals and objectives
  • Performs personnel management functions including scheduling of vacations, personnel development and performance evaluations
  • Tracks and trends relevant technical and business process metrics to ensure operations are performing effectively and efficiently
  • Reviews and approves Standard Operating Procedures, specifications, regulatory filing or other controlled documents as needed
  • Leads implementation of long-term planning for the process, staff and budget
This role might be for you if:
  • You have demonstrated technical expertise in drug product manufacture and/or product development and validation.
  • You are knowledgeable of industry practices and laws (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.).
  • You hold strong project management, interpersonal, cross- cultural, communication, negotiation and problem-solving skills.
To be considered for the Manager Fill Finish Manufacturing you must be willing and able to work 1st shift, Monday-Friday, 8:00 a.m.-4:30 p.m. You must have the following; Associate Manager - BS in a scientific/engineering subject area, or related field, with 4 years of related experience in a pharmaceutical / biologics cGMP environment. Manager - BS in a scientific/engineering subject area, or related field, with 5 years of related experience in a pharmaceutical / biologics cGMP environment. Sr Manager - BS in a scientific/engineering subject area, or related field, with 6 years of related experience in a pharmaceutical / biologics cGMP environment. Or equivalent combination of education and experience. Technology transfer and equipment and process validation experience with device assembly, labelling and packaging operations preferred. Previous experience providing technical support. Level is figured out 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.