We are currently looking to fill a Manager Drug Product Manufacturing (Syringe Assembly) position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. The Manager Drug Product Manufacturing (Syringe Assembly) is accountable for all facets of internal clinical and commercial scale syringe and auto-injector Assembly. This is a leadership role with focus on the start-up and execution of GMP operations, 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 Manager will work directly with the Sr. Manager of Drug Product Finish Operations 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 Drug Product Manufacturing (Syringe Assembly,) a typical day might include the following:
Provides leadership, vision, and management to the Assembly team.
Leads all aspects of Assembly Operations at the facility to manufacture commercial and clinical parenteral medicines according to approved protocols, regulations, and schedules.
Directly coordinates Assembly of pre-filled syringes (including safety systems) and auto-injectors and associated labeling.
Solves problems and resolves issues impeding department goals.
Partners with department management to implement new production processes.
Leads Assembly group metrics and goals, supervises performance to objectives, and drives continuous improvement initiatives that are critical to meeting patient and business needs.
Participates in implementation of long-term planning for the process, staff, and budget.
Tracks and trends relevant technical and business process metrics to ensure operations are performing optimally and efficiently.
Resolves manufacturing and facility issues to mitigate any supply disruptions to our patients.
Writes, reviews and/or approves Standard Operating Procedures, specifications, regulatory filings, or other controlled documents as needed.
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.
This role might be for you if:
You have been in a manufacturing leadership role with experience in running a multi-tiered organization.
Interprets data to drive decisions, achieve production goals, and promote organizational health.
Experience with multiproduct biologics facility start-up is helpful.
Experience interacting with multiple health authorities (e.g. FDA, EMA, PMDA, etc.)
Deep understanding of production commissioning, automation, and validation.
Consistent track record to initiate and develop a team with multi-functional members as well as direct reports.
Effective at speaking publicly to a wide audience of experience, skills, and expertise.
Enjoys being challenged to think critically, accepting new technologies and has a passion for continuously improving processes.
To be considered for the Manager Drug Product Manufacturing (Syringe Assembly) you must have the following; 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 Assembly and labeling 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.