Staff Process Specialist - Manufacturing

About the role

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.

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
• 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
• 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
• Writes, reviews, and/or approves Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed
• Leads and implements continuous improvement initiatives
• Acts as system owner for defined manufacturing equipment and 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.

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.

Qualifications

• BS in Life Sciences or related field
• 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

Skills

• Technical problem solving
• Process improvement
• Collaboration and teamwork
• Communication and presentation
• Regulatory compliance
• Equipment operation and validation
• Continuous improvement

Benefits

Includes a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit here.

For other locations, additional information will be provided during the recruitment process.

If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site.