Staff Process Specialist, Fill Finish Manufacturing

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 Process Specialist, Manufacturing (Principal, Staff, or Senior Staff) to join our IOPS team, providing on-the-floor technical direction and leadership across our biopharmaceutical manufacturing process. In this role, you will resolve process challenges, coach manufacturing personnel, lead investigations, and drive continuous improvement, while collaborating with Process Science, Engineering, Quality, Regulatory, and Facilities teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: East Greenbush, New York, United States

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

Discover your role:

Provide on-the-floor technical input to resolve process problems, coach manufacturing personnel on critical process steps, and support implementation of process and work system improvements in the production suites

Lead investigations into process variances, support CAPA implementation, and guide validation activities involving manufacturing equipment and processes

Support technology transfer of the manufacturing process, liaising with process science and technology transfer teams on transfer and startup activities

Track, trend, and present relevant technical and business process metrics; prepare reports by collecting and analyzing information for review with the Process Science Group

Write, review, and approve SOPs, specifications, regulatory filings, and other controlled documents; perform cGMP audits and represent Manufacturing during regulatory and client audits

Act as system owner for defined manufacturing equipment, coordinating all non-routine activities and ensuring policies and procedures comply with regulatory requirements

Lead and implement continuous improvement initiatives; support safety improvements requiring technical and engineering input

Interface cross-functionally with Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance, and Quality Control

Knowledge of cGMP manufacturing and familiarity with formulation, aseptic filling, visual inspection, assembly, labeling, and/or packaging of liquid and lyophilized injectable products

Technology transfer and equipment and process validation experience in aseptic parenteral fill/finish operations preferred

Experience with lyophilization a plus; experience operating and qualifying highly automated equipment a plus

This role requires:

BS in Life Sciences or a related field

Principal Process Specialist: 8+ years of relevant cGMP manufacturing, engineering, or scientific experience

Staff Process Specialist: 10+ years of relevant cGMP manufacturing, engineering, or scientific experience

Senior Staff Process Specialist: 12+ years of relevant cGMP manufacturing, engineering, or scientific experience

May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role

Gowning: Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)

Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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.

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, and 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.

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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$92,200.00 - $206,100.00