Manager Drug Product Filling Operations

We are currently looking to fill a Manager of Drug Product Filling Operations with a 1st shift, Monday-Friday, 8:00am-4:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. The Manager of Drug Product Filling Operations is accountable for the aseptic filling of clinical and commercial drug product including materials management, preparation of equipment, format parts, and components as well as formulation and aseptic filling of drug product and placebo into vials and syringes. This is a leadership role with focus on the start-up and execution of GMP operations, ensuring the facility is properly staffed and trained, as well as supporting a production planning process that is multifaceted and flexible to meet the needs of Regeneron’s patients. The Manager will work directly with Drug Substance and Finish manufacturing management to ensure production timelines are met and be a key member of various management teams within Industrial Operations and Product Supply (IOPS).

As a Manager of Drug Product Filling Operations, a typical day might include the following:

• Providing leadership, vision, and management to the assigned team.

• Directly coordinates formulation of bulk drug product and placebo

• Directly responsible for preparation of equipment, format parts, and components to support aseptic filling.

• Supervises aseptic filling of vials and syringes.

• Develops daily/weekly production schedules, sets priorities, and handles availability of resources.

• Troubleshoots or resolves issues impeding department daily/weekly objectives/results.

• Coordinates with other departments such as Facilities, Quality Assurance, Quality Control, Regulatory, and EHS to drive business needs as required.

• Participates in the development and maintenance of a safe manufacturing environment.

• Establishes methods in compliance with regulatory, plant, and corporate policies.

• Participates in safety meetings, incident investigation, and takes appropriate corrective action to eliminate hazardous conditions.

• Develops department and individual goals / objectives; supervises performance to objectives and counsels, trains, and develops staff as needed.

• Performs personnel management functions including scheduling of vacations, personnel development, and performance evaluations.

• Participates in implementation of long-term planning for the process, staff, and budget.

• Drives continual improvement projects and opportunities.

• Implements Quality Management System assignments (CAPA, Deviation, Investigation, Change Control, etc.).

• Builds and/or approves department Policies, Standard Operating Procedures, Work Instructions, Job Aids, specifications, and other controlled documentation as needed.

• Creates, reviews, and conducts operations training programs and assures training is conducted in compliance with cGMP and GDP requirements.

• Represents manufacturing during regulatory and client audits.

• Provides operational leadership and support for new technology and equipment design, installation, and qualification.

• Recommends capital expenditures and provides support to Technical Services and Engineering in the realization of capital projects.

• Guides and coordinates validation activities involving equipment and processes.

• Leads department metrics and goals, monitors performance to objectives, and drives continuous improvement initiatives that are critical to meeting patient and business needs.

• Rapidly and accurately communicates issues to department Directors.

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

• Provides technical input to resolve manufacturing process challenges.

• Demonstrate manufacturing leadership with experience with running a multi-tiered organization.

• Interprets data to drive decisions, achieve production goals, and promote interpersonal health

• Experienced in coordinating manufacturing operations in an aseptic biologics manufacturing environment.

• Experience with multiproduct biologics facility start-up is helpful.

• Experience interacting with multiple health authorities (e.g. FDA, EMA, PMDA, etc.).

• Must have an approach and ability to drive inspection readiness for the site at all times.

• Deep understanding of area and equipment start-up, automation, and validation.

• Proven track record to initiate and manage a team with cross-functional members as well as direct reports.

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

• Effective at addressing a wide audience of experience, skills, and expertise.

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

• Ability to think strategically and tackle sophisticated challenges while being able to quickly adapt to emerging situations.

• Enjoys being challenged to think critically, accepting new technologies and has a passion for continuously improving processes and operations.

• Associate Manager: BS/BA in a scientific/engineering discipline, or related field, and 6 years of manufacturing experience in a cGMP environment, including prior supervisory experience, or equivalent combination of education and experience.

• Manager: BS/BA in, a scientific/engineering discipline, or related field, and 7 years of manufacturing experience in a cGMP environment, including prior supervisory experience, or equivalent combination of education and experience.

• Sr. Manager: BS/BA in a scientific/engineering discipline, or related field, and 8 years of manufacturing experience in a cGMP environment, including prior supervisory experience, or equivalent combination of education and experience.

• Previous experience with aseptic filling preferred.

Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.