Executive Director Internal Fill/Finish Manufacturing

We are currently looking to fill an Executive Director of Internal Fill/Finish Manufacturing position within our Fill Finish team. This position is responsible for clinical and commercial drug product manufacturing operations. This is a leadership role with focus on the start-up and execution of GMP operations for all production areas, ensuring the facility is accurately staffed and trained and supporting a production planning process that is multifaceted and flexible to meet the needs of Regeneron’s patients. The Executive Director will also be responsible for representing fill/finish manufacturing on the site leadership team and serving as a key member of various management teams within Industrial Operations and Product Supply (IOPS).

In this role, a typical day may include the following:

• Provides executive level leadership, vision and management to the Fill/Finish site.

• Leads all aspects of Fill/Finish Operations at the facility to manufacture commercial and clinical parenteral medicines according to approved protocols, regulations and schedules.

• Guides and influences validation activities involving equipment and processes.

• Partners with Project Management to implement new production processes, including but not limited to formulation, filling, lyophilization, PFS and auto injector assemblies and finished product label and carton.

• Leads key manufacturing metrics/site goals, supports critical program milestones and drives continuous improvement initiatives that are essential to meeting patient and business needs.

• Leads all aspects of production planning and builds production schedules based on supply chain demand forecasts and resource availability.

• Manages relationships with external departments to schedule activities such as maintenance, cleaning, validation, microbial monitoring, etc.

• Tracks start and end times of unit operations to monitor schedule attainment.

• Owns resource and capacity planning initiatives and works to seek improvement of systems and tools.

• Collaborates with Human Resources and other functions to develop a multi-year staffing and recruiting plan for the facility.

• Quickly and accurately communicates issues to Senior Leadership.

• Resolves manufacturing and facility issues to mitigate any supply disruptions to our patients.

• Works effectively across IOPS departments, such as Quality Assurance, Facilities, Engineering, External Manufacturing, MSAT, Regulatory, Quality Control, IT and Supply Chain.

• Writes, reviews and/or approves Standard Operating Procedures, specifications, regulatory filing or other controlled documents as needed.

• Ensures the effective use of material, equipment and personnel in producing quality products.

• Ensures that IOPS safety standards are maintained.

• Prepares and coordinates expense and capital budgets for the facility.

• Recommends capital expenditures and aids in the realization of capital projects.

• Oversees, supports and participates in cGMP audits of all production areas within the facility.

• Maintains site inspection readiness and represents the manufacturing facility during regulatory and client audits.

• Provides technical input to resolve manufacturing process challenges.

This role may be a fit for you if you:

• Can demonstrate expert knowledge of parenteral manufacturing, including finished doses for both clinical and commercial medicines.

• Are highly experienced in leading all aspects of manufacturing operations in an aseptic biologics manufacturing environment.

• Are excellent at developing staff, teams and future leaders and leads by example.

• Are experienced with multiproduct biologics facility start-up is preferred.

• Have working knowledge of industry practices, global regulations and experience interacting with across multiple health authorities (e.g. FDA, EMA, PMDA, etc.).

• Have solid understanding of production planning, scheduling, and leveling

• Hold a mentality and ability to drive inspection readiness for the site at all times.

• Have deep understanding of aseptic processes, equipment, automation, validation and cleanrooms and other classified area requirements.

• Have a proven track record of leading a site leadership team with cross-functional members as well as direct reports.

• Are excellent at collaborating with key functions (Quality Assurance, Facilities, Supply Chain, Project Management, etc.) and efficient at removing barriers.

• Are knowledgeable of transferring aseptic parenteral filling, device assembly and finish label & pack operations.