Process Specialist - Manufacturing

Process Specialist — Manufacturing

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.

Location:

East Greenbush, New York, United States

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

• 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

• 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