Process Specialist - 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 Manufacturing Process Specialist (Associate through Senior level) to join our IOPS team, providing technical support across our manufacturing processes and playing a key role in the implementation and transfer of our production programs. In this role, you will resolve process challenges, support manufacturing personnel on the floor, and drive continuous improvement — while collaborating with Process Sciences, Engineering, Maintenance, 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:

• Liaise with process science and technology transfer teams on the transfer and startup of manufacturing processes; serve as a key technical contributor to manufacturing records, batch sheets, and procedures
• Provide technical input to resolve process problems on and off the production floor; support manufacturing personnel in building technical knowledge of critical process steps
• Write and review SOPs and other controlled documents; modify process method files through the quality system in alignment with change control requirements
• Support CAPA implementation for process-related improvements and contribute to investigations into process variances in accordance with site procedures
• Partner cross-functionally with Maintenance, Process Sciences, Engineering, Facilities, Process Development, Regulatory, Quality Assurance, and Quality Control to resolve process issues and implement improvements
• Support Right First Time (RFT) programs on the floor and implement continuous improvement initiatives across manufacturing operations
• Represent Manufacturing during regulatory and client audits; uphold the highest safety standards and support safety improvements requiring technical input
• Experience in a cGMP manufacturing environment with familiarity with drug substance or drug product manufacturing processes preferred

This role requires:

• BS in Life Sciences or a related field
• Associate Specialist: 0–2 years of relevant cGMP manufacturing, engineering, or scientific experience
• Specialist: 2+ years of relevant cGMP manufacturing, engineering, or scientific experience
• Senior Specialist: 5+ 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)

$62,355.00 - $128,700.00