Regeneron is currently looking for a Quality Control Supervisor for our Microbiology team with a Monday-Friday, 8am-4:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins as well as those involved in clinical studies. Our Quality Control Microbiology Department is responsible for activities related to pharmaceutical microbiology including environmental, personnel and utility monitoring, raw material, in-process, and product release testing. This position will be responsible for ensuring daily operations are completed accurately, timely, and reliably to ensure our medicines are safe and effective before reaching patients around the world. This is an excellent opportunity to join a select group of colleagues while working on molecules that help improve patients' lives.
As a QC Supervisor, a typical day might include the following:
• Responsible for QC microbiological aspects of cGMP compliance
• Coordinates and performs activities related to the evaluation of complex microbiological test data pertaining to environmental monitoring, raw material, and in process and product samples
• Assist in microbiological root cause investigations and provide technical advice as needed
• Facilitates cross functional meetings to collaborate on process improvement projects
• Design and implement microbiological experimental studies in support of protocol development or improvement as needed
• Collaborates on the preparation of technical proposals, amendments, reports and memoranda
• Create and/or revise microbiological processes, procedures (e.g., SOPs, Work Instructions, Job Aids) and associated trainings
• Execute personnel management functions including performance evaluations, personnel development, scheduling, timesheets, and ensures training requirements are met
This role might be for you if you:
• Thrives in a fast-paced environment and adapts to changing priorities
• Applies well developed technical knowledge to navigate through ambiguity and drive continuous improvements
• Proactively communicates with transparency to audiences of various technical understanding; ability to work under limited supervision and accepts responsibility for deadlines
• Leads and collaborates on various projects to improve processes and performance
• Advanced root cause problem solver that makes timely quality decisions
• Coaches and supports the development of troubleshooting and leadership skills by mentoring/supervising others
• Participated in or reviewed disinfectant efficacy or method validation studies
• Have experience with environmental monitoring, aseptic techniques, microbiological testing (e.g., microbial identification, endotoxin, bioburden, and sterility) and evaluation of raw materials.
• Have experience working in a GMP environment
To be considered for the QC Microbiology Supervisor you must be willing and able to work, Monday-Friday, 8am-4:30pm. You must have the following; BS/BA in Biochemistry, Chemistry or Biology or related field and 5+ years of relevant experience, preferably in the pharmaceuticals or biotechnology industries. Experience with pharmaceutical documentation practices and demonstrated leadership skills required.
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.