Staff Process Specialist, Fill Finish Manufacturing

About the role

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.

Responsibilities

• 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

Requirements

• 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

Qualifications

• Principal Process Specialist: BS in Life Sciences or a related field and 8+ years of relevant cGMP manufacturing, engineering, or scientific experience
• Staff Process Specialist: BS in Life Sciences or a related field and 10+ years of relevant cGMP manufacturing, engineering, or scientific experience
• Senior Staff Process Specialist: BS in Life Sciences or a related field and 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

Cleanroom and Physical Requirements

• Ability to gown in full cleanroom attire (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