Executive Director Internal Fill/Finish Manufacturing

Location: East Greenbush
Posted on: June 23, 2025

Job Description:

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 Regenerons 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. Have working knowledge of financial operations in a manufacturing environment. Have the ability to think strategically and solve sophisticated challenges while being able to quickly adapt to emerging situations. Enjoy being challenged to think critically, embracing new technologies and has a passion for continuously improving processes and operations. To be considered for this role you must hold a Bachelors degree in any of the physical or biological sciences or engineering field and the following amount of relevant experience: Executive Director: 15 years of biopharmaceutical/biotech experience in a GMP drug product production facility, including 5 years of experience reporting to or interacting closely with Senior Leadership, or equivalent combination of education and experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $236,100.00 - $393,500.00

Keywords: , Worcester , Executive Director Internal Fill/Finish Manufacturing, Manufacturing , East Greenbush, Massachusetts