Regeneron is currently looking for an Associate Director to join our Quality Control (QC) Microbiology Fill Finish Team. This position is responsible for the management of QC laboratories/sampling for assigned functional areas, including management of laboratory records and deviations. Assigned Quality Control functional areas include Raw Materials, Microbiology, Chemistry, Biochemistry, Biology laboratories.
As an Associate Director- QC Microbiology, a typical day might include the following:
- Provides key leadership, vision and direction to the QC Micro Operations fill/finish group while providing operational expertise.
- Effectively leads and develops QC Micro Operations fill/finish staff.
- Coordinates timely and right-first-time delivery of test results required by Manufacturing Operations and Validation groups.
- Acts as a key liaison between Quality Control, Manufacturing, and Quality operations on-site.
- Maintains a functional and compliant laboratory and environmental monitoring operations.
- Leads all aspects of the day-to-day collection of environmental monitoring and specification testing for fill/finish operations.
- Motivates and encourages the QC Operations team to support strong interactions and partnerships with manufacturing, facilities, and quality assurance teams.
- Collaborates with Quality Control junior management and supports team to ensure critical metrics are consistently met.
- Manages and develops the performance of direct reports by setting clear expectations.
- Ensures timely issue escalation to Quality senior management and cross-functional support teams.
- Ensures analysts are appropriately trained before any task execution.
- Participates in inspections conducted by external agencies and business partners.
This role might be for you if you:
- Have experience with filling and packaging operations for drug product material.
- Able to travel to contract manufacturers or business partners, as the need arises, approximately 10-15% of the time.
- Enjoy interacting with cross-functional teams including Manufacturing, Quality Assurance, Validation, and Facilities.
- Can demonstrate technical experience with sterility testing and Aseptic Processing Simulation (APS) procedures.
- Have knowledge of industry practices and regulations (cGMP, Annex 1) across multiple health authorities (e.g. FDA, EMA, MHRA, etc.)
To be considered for the Associate Director- QC Microbiology you must be willing and able to work Monday-Friday, 8am-5pm. You must have a BS/BA in biology, microbiology or related field and 10+ years of related experience including supervisory/ leadership experience. GMP experience and fill finish experience is 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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$142,700.00 - $232,900.00