Process Specialist - Manufacturing

About the Role

Regeneron is 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.

Location & Schedule

East Greenbush, New York, United States. Monday – Friday, 8am – 4:30pm.

Key Responsibilities

• 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

Qualifications

• 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
• Experience in a cGMP manufacturing environment with familiarity with drug substance or drug product manufacturing processes preferred

Physical & Gowning Requirements

• Full cleanroom attire (examples may include: 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