Staff Process Specialist - Manufacturing

Regeneron Pharmaceuticals • Rensselaer, NY

4d • $92,200 - $206,100 • Onsite

About The Position

The Staff Process Specialist - Manufacturing position provides on the floor direction on the manufacturing process. Key member in the implementation of the manufacturing production program. As a Staff Process Specialist - Manufacturing, a typical day might include the following: Provides technical input to resolve process problems both on and off the production suites Coaches manufacturing personnel to increase technical knowledge of critical process steps on the floor. Supports Manufacturing personnel on implementing improvements to the process or work systems in the suites. Supports CAPA implementation on process related improvements. Supports onsite educational programs to enhance technical competence of manufacturing personnel. Supports all aspects of the manufacturing process according to approved protocols, regulation, and schedule Supports the technology transfer of the manufacturing process Liaises with the process science/technology transfer teams in relation to the transfer and startup of the manufacturing process. Prepares reports by collecting, analyzing, and summarizing information and trends. Operations member reviewing trends with the Process Science Group. Present out on process trends. Leads investigations into process variances according to site procedures. Ensures that policies and procedures are effectively administered and that they comply with regulatory requirements. Communicates well with supervisors on major problems regarding the process, schedules and materials. Guides and oversees validation activities involving manufacturing equipment and processes. Interfaces with other departments, such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control. Works to the highest safety standards. Supports safety improvements which require technical/engineering input. Tracks and trends relevant technical and business process metrics to ensure operations are performing effectively and efficiently. Performs cGMP audits of production area. Represents manufacturing during regulatory and client audits. Will also respond to some of the findings from these audits. Writes, reviews, and/or approves Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed. Leads and implements continuous improvement initiatives. Will act as system owner for defined manufacturing equipment and will be involved in the scheduling of all non-routine activities for that equipment.

Requirements

• Knowledge of cGMP manufacturing environment and familiarity with formulation, aseptic filling, visual inspection (manual and automated), assembly, labeling, and/or packaging of liquid and lyophilized injectable products.
• Demonstrated strong interpersonal, cross-cultural, communication, negotiation, and problem-solving skills.
• Exhibits confidence, has a high emotional IQ, and demonstrated ingenuity, creativity and resourcefulness.
• Ability to gain understanding from provided instructions and work towards established goals individually or as part of a team.
• Ability to understand and listen to team members and stakeholders’ needs while supporting a positive team environment
• BS in Life Sciences or related field and Principal Process Specialist - 8 years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry or equivalent combination of education and experience.
• Staff Process Specialist - 10 years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry.
• Senior Staff Process Specialist - 12 years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry.
• May consider experience in lieu of education OR equivalent combination of education and experience.
• Level is determined based on qualifications relevant to the role.

Nice To Haves

• Technology transfer and equipment / process validation experience of aseptic, parenteral fill/finish operations preferred.
• Previous experience providing technical support preferred.
• Experience with lyophilization is a plus.
• Experience with operating and qualifying equipment with high levels of automation is a plus.

Responsibilities

• Provides technical input to resolve process problems both on and off the production suites
• Coaches manufacturing personnel to increase technical knowledge of critical process steps on the floor.
• Supports Manufacturing personnel on implementing improvements to the process or work systems in the suites.
• Supports CAPA implementation on process related improvements.
• Supports onsite educational programs to enhance technical competence of manufacturing personnel.
• Supports all aspects of the manufacturing process according to approved protocols, regulation, and schedule
• Supports the technology transfer of the manufacturing process
• Liaises with the process science/technology transfer teams in relation to the transfer and startup of the manufacturing process.
• Prepares reports by collecting, analyzing, and summarizing information and trends.
• Operations member reviewing trends with the Process Science Group.
• Present out on process trends.
• Leads investigations into process variances according to site procedures.
• Ensures that policies and procedures are effectively administered and that they comply with regulatory requirements.
• Communicates well with supervisors on major problems regarding the process, schedules and materials.
• Guides and oversees validation activities involving manufacturing equipment and processes.
• Interfaces with other departments, such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
• Works to the highest safety standards.
• Supports safety improvements which require technical/engineering input.
• Tracks and trends relevant technical and business process metrics to ensure operations are performing effectively and efficiently.
• Performs cGMP audits of production area.
• Represents manufacturing during regulatory and client audits.
• Will also respond to some of the findings from these audits.
• Writes, reviews, and/or approves Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
• Leads and implements continuous improvement initiatives.
• Will act as system owner for defined manufacturing equipment and will be involved in the scheduling of all non-routine activities for that equipment.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal