Manager Internal Fill/Finish MFG

Company Name: Regeneron

We are currently looking to fill a Manager Internal Fill/Finish Manufacturing (MFG) position. The Manager Internal Fill/Finish MFG manages all facets of internal clinical and commercial scale fill / finish, inspection, assembly and packaging activities.

Responsibilities

In this role, a typical day might include the following:

• Participates in equipment / new technology design, installation and qualification. Acts as fill / finish subject matter expert (SME), coordinating with Combination Products, Validation and Quality Assurance (tech transfer studies / tech transfer, investigations, innovative technology adoption).
• Drives innovation in sterile / aseptic processing by keeping abreast of latest technological advancements and ensuring a creative environment and implementation along the business case and Regeneron’s needs.
• Guides and oversees validation and technical transfer activities involving fill / finish equipment and processes.
• Interfaces with other departments such as Facilities, Process Development, Process Analytical Sciences, Combination Products, Regulatory, Quality Assurance and Quality Control.
• Builds capability / builds a team and is responsible for overseeing the training of operations and maintaining metrics relative organizational performance.
• 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.
• Represents manufacturing during regulatory and client audits.
• Develops department goals and objectives.
• Works closely with staff to develop and manage individual goals and objectives.
• Performs personal management functions including scheduling of vacations, personnel development and performance evaluations.
• Tracks and trends relevant to 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.
• Participates in implementation of long-term planning for the process, staff and budget.

This Role Might Be For You If

• Knowledge of cGMP manufacturing environment and familiarity with formulation, aseptic filling, visual inspection (manual and automated), assembly, labeling, and/or packaging of liquid and lyophilized injectable products.
• Demonstrated strong interpersonal, cross-cultural, communication, negotiation, and problem-solving skills.
• Exhibits confidence, has a high emotional IQ, and demonstrates ingenuity, creativity and resourcefulness.
• Ability to gain understanding from provided instructions and work towards established goals individually or as part of a team.
• Ability to understand and listen to team members and stakeholders’ needs while supporting a positive team environment.
• Experience with regulatory inspections as a subject matter expert is preferred.
• Technology transfer and equipment / process validation experience of aseptic, parenteral fill/finish operations preferred.
• Experience with change control process and compliance investigation is preferred.
• Previous experience providing technical support is a plus.
• Experience with operating and qualifying equipment with high levels of automation is a plus.
• Experience with creation of manufacturing batch records and standard operating procedures preferred.

Qualifications

To be considered for the Associate Manager Internal Fill/Finish MFG you must have a BS/BA in engineering, materials science, physical or biological sciences and 5 years of cGMP manufacturing experience, including prior supervisory experience, or equivalent combination of education and experience.

To be considered for the Manager Internal Fill/Finish MFG you must have a BS/BA in engineering, materials science, physical or biological sciences and 6 years of cGMP manufacturing experience, including prior supervisory experience, or equivalent combination of education and experience.

To be considered for the Sr Manager Internal Fill/Finish MFG you must have a BS/BA in engineering, materials science, physical or biological sciences and 7 years of cGMP manufacturing experience, including prior supervisory experience, or equivalent combination of education and experience.

Apply Now!

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!

Equal Opportunity Employer

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.

Salary Information

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)

$90,800.00 - $203,000.00