Staff Process Specialist, Fill Finish Manufacturing
Regeneron
August 22, 2026
On-site
East Greenbush, NY
Operations
Discover Your Role
- Provide on-the-floor technical input to resolve process problems; coach manufacturing personnel on critical process steps; support implementation of process and work system improvements in production suites.
- Lead investigations into process variances; support CAPA implementation; guide validation activities involving manufacturing equipment and processes.
- Support technology transfer of the manufacturing process; liaise with process science and technology transfer teams on transfer and startup activities.
- Track, trend, and present technical and business process metrics; prepare reports for review with the Process Science Group.
- Write, review, and approve SOPs, specifications, regulatory filings, and other controlled documents; perform cGMP audits; represent Manufacturing during regulatory and client audits.
- Act as system owner for defined manufacturing equipment; coordinate non-routine activities; ensure compliance 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/process validation experience in aseptic parenteral fill/finish preferred; lyophilization experience a plus; operating/qualifying highly automated equipment a plus.
This Role Requires
- BS in Life Sciences or related field.
- Principal Process Specialist: 8+ years relevant cGMP manufacturing/engineering/scientific experience; Staff: 10+ years; Senior Staff: 12+ years.
- May consider equivalent education/experience; full cleanroom attire; remove jewelry/makeup/nail adornments.
- Ability to perform physical requirements for up to 10 hours in a clean room.
Apply now to take your first step towards living the Regeneron Way!
- Provide on-the-floor technical input to resolve process problems; coach manufacturing personnel on critical process steps; support implementation of process and work system improvements in production suites.
- Lead investigations into process variances; support CAPA implementation; guide validation activities involving manufacturing equipment and processes.
- Support technology transfer of the manufacturing process; liaise with process science and technology transfer teams on transfer and startup activities.
- Track, trend, and present technical and business process metrics; prepare reports for review with the Process Science Group.
- Write, review, and approve SOPs, specifications, regulatory filings, and other controlled documents; perform cGMP audits; represent Manufacturing during regulatory and client audits.
- Act as system owner for defined manufacturing equipment; coordinate non-routine activities; ensure compliance 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/process validation experience in aseptic parenteral fill/finish preferred; lyophilization experience a plus; operating/qualifying highly automated equipment a plus.
This Role Requires
- BS in Life Sciences or related field.
- Principal Process Specialist: 8+ years relevant cGMP manufacturing/engineering/scientific experience; Staff: 10+ years; Senior Staff: 12+ years.
- May consider equivalent education/experience; full cleanroom attire; remove jewelry/makeup/nail adornments.
- Ability to perform physical requirements for up to 10 hours in a clean room.
Apply now to take your first step towards living the Regeneron Way!