Staff Process Specialist - Manufacturing
Regeneron
9 days ago
On-site
East Greenbush, NY
Operations
Role Responsibilities:
- Provide technical input to resolve process problems on and off the production suites.
- Coach manufacturing personnel on critical process steps.
- Support implementation of process/work improvements in the suites.
- Support CAPA implementation for process-related improvements.
- Support onsite educational programs to enhance manufacturing technical competence.
- Support manufacturing activities according to approved protocols, regulations, and schedules.
- Support technology transfer and liaison with process science/technology transfer teams for transfer and startup.
- Prepare and present reports by collecting, analyzing, and summarizing information and trends.
- Lead investigations into process variances per site procedures.
- Ensure policies/procedures are administered and comply with regulatory requirements.
- Communicate with supervisors on major process, schedule, and material issues.
- Guide and oversee validation activities for manufacturing equipment and processes.
- Interface with Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance, and Quality Control.
- Support safety standards and technical/engineering safety improvements.
- Track and trend technical and business process metrics.
- Perform cGMP audits of the production area.
- Represent manufacturing during regulatory and client audits and respond to some findings.
- Write/review/approve SOPs, specifications, regulatory filings, and other controlled documents as needed.
- Lead and implement continuous improvement initiatives.
- Act as system owner for defined manufacturing equipment and schedule non-routine activities.
Qualifications & Required/Preferred Skills:
- BS in Life Sciences or related field.
- cGMP manufacturing environment knowledge; familiarity with formulation, aseptic filling, visual inspection (manual/automated), assembly, labeling, and/or packaging of liquid and lyophilized injectable products.
- Strong interpersonal, communication, negotiation, and problem-solving skills.
- Ability to work toward established goals individually or as part of a team.
- Ability to understand and support stakeholder/team needs.
- Preferred: technology transfer and equipment/process validation experience (aseptic, parenteral fill/finish); previous technical support experience.
- Plus: lyophilization experience; experience operating/qualifying high-automation equipment.
Experience Level (based on title):
- Principal Process Specialist: 8 years relevant cGMP manufacturing/engineering/scientific.
- Staff Process Specialist: 10 years relevant cGMP manufacturing/engineering/scientific.
- Senior Staff Process Specialist: 12 years relevant cGMP manufacturing/engineering/scientific.
- May consider equivalent experience in lieu of education.
Application Instructions:
- Apply now.
- Provide technical input to resolve process problems on and off the production suites.
- Coach manufacturing personnel on critical process steps.
- Support implementation of process/work improvements in the suites.
- Support CAPA implementation for process-related improvements.
- Support onsite educational programs to enhance manufacturing technical competence.
- Support manufacturing activities according to approved protocols, regulations, and schedules.
- Support technology transfer and liaison with process science/technology transfer teams for transfer and startup.
- Prepare and present reports by collecting, analyzing, and summarizing information and trends.
- Lead investigations into process variances per site procedures.
- Ensure policies/procedures are administered and comply with regulatory requirements.
- Communicate with supervisors on major process, schedule, and material issues.
- Guide and oversee validation activities for manufacturing equipment and processes.
- Interface with Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance, and Quality Control.
- Support safety standards and technical/engineering safety improvements.
- Track and trend technical and business process metrics.
- Perform cGMP audits of the production area.
- Represent manufacturing during regulatory and client audits and respond to some findings.
- Write/review/approve SOPs, specifications, regulatory filings, and other controlled documents as needed.
- Lead and implement continuous improvement initiatives.
- Act as system owner for defined manufacturing equipment and schedule non-routine activities.
Qualifications & Required/Preferred Skills:
- BS in Life Sciences or related field.
- cGMP manufacturing environment knowledge; familiarity with formulation, aseptic filling, visual inspection (manual/automated), assembly, labeling, and/or packaging of liquid and lyophilized injectable products.
- Strong interpersonal, communication, negotiation, and problem-solving skills.
- Ability to work toward established goals individually or as part of a team.
- Ability to understand and support stakeholder/team needs.
- Preferred: technology transfer and equipment/process validation experience (aseptic, parenteral fill/finish); previous technical support experience.
- Plus: lyophilization experience; experience operating/qualifying high-automation equipment.
Experience Level (based on title):
- Principal Process Specialist: 8 years relevant cGMP manufacturing/engineering/scientific.
- Staff Process Specialist: 10 years relevant cGMP manufacturing/engineering/scientific.
- Senior Staff Process Specialist: 12 years relevant cGMP manufacturing/engineering/scientific.
- May consider equivalent experience in lieu of education.
Application Instructions:
- Apply now.