Manager Internal Fill/Finish MFG

Role Summary

Manager Internal Fill/Finish MFG responsible for managing all facets of internal clinical and commercial scale fill/finish, inspection, assembly and packaging activities.

Responsibilities

• Participates in equipment / new technology design, installation and qualification. Acts as fill / finish subject matter expert (SME), coordinating with Combination Products, Validation and Quality Assurance (tech transfer studies / tech transfer, investigations, innovative technology adoption).
• Drives innovation in sterile / aseptic processing by keeping abreast of latest technological advancements and ensuring a creative environment and implementation along the business case and Regeneron‚Äôs needs.
• Guides and oversees validation and technical transfer activities involving fill / finish equipment and processes.
• Interfaces with other departments such as Facilities, Process Development, Process Analytical Sciences, Combination Products, Regulatory, Quality Assurance and Quality Control.
• Builds capability / builds a team and is responsible for overseeing the training of operations and maintaining metrics relative organizational performance.
• Provides leadership, vision and management to the manufacturing team.
• Develops and recommends manufacturing policies, schedules, procedures and programs.
• Recommends capital expenditures and aids in the realization of capital projects.
• Represents manufacturing during regulatory and client audits.
• Develops department goals and objectives.
• Works closely with staff to develop and manage individual goals and objectives.
• Performs personal management functions including scheduling of vacations, personnel development and performance evaluations.
• Tracks and trends relevant to technical and business process metrics to ensure operations are performing effectively and efficiently.
• Reviews and approves Standard Operating Procedures, specifications, regulatory filing or other controlled documents as needed.
• Participates in implementation of long-term planning for the process, staff and budget.

Qualifications

• 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, high emotional IQ, 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‚Äô needs while supporting a positive team environment.
• Experience with regulatory inspections as a subject matter expert is preferred.
• Technology transfer and equipment / process validation experience of aseptic, parenteral fill/finish operations preferred.
• Experience with change control process and compliance investigation is preferred.
• Previous experience providing technical support is a plus.
• Experience with operating and qualifying equipment with high levels of automation is a plus.
• Experience with creation of manufacturing batch records and standard operating procedures preferred.

Education

• BS/BA in engineering, materials science, physical or biological sciences with 5‚Äì7 years of cGMP manufacturing experience and prior supervisory experience (specific requirement depends on level: Associate Manager 5 years; Manager 6 years; Senior Manager 7 years).

Additional Requirements

• Level will be determined based on relevant education and experience.