As a Senior Manager in QC you will manage a team to oversee the laboratory Quality Control testing of in-process, stability and final drug products. Has technical responsibility for all chemical aspects of QC testing.
A typical day might include, but is not limited to, the following:
- Coordinating with members of Manufacturing, Stability, and Business Ops to provide analytical support
- Managing QC Analysts, distributing work load, and monitoring progress
- Overseeing product testing to ensure efficient and compliant operations
- Reviewing test reports
- Ensuring QC Analysts receive proper training
- Attending meetings to keep informed of manufacturing priorities
- Ensuring that safety standards are maintained
- Ensuring compliance with applicable cGMP regulations and SOPs
- Investigating atypical and OOS test results as necessary
- Managing assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory
- Managing assay transfer externally from QC laboratory to contract labs, includes audits if needed
- Overseeing QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness
- Tracking and coordinating major analytical investigations
- Tracking and monitoring timeline of analytical validation projects
- Monitoring the team performance for Compliance events, tracking, assisting and organizing continuous improvement events
- Interacting with Regulatory Agencies as needed to ensure cGMP compliance
- Special projects as assigned
- Performing personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations
To be considered for this opportunity you should have a BS/BA in Chemistry, Biology or related field with 8+ years’ relevant experience (pharmaceutical or biotechnology industry) in laboratory management and analytical sciences and 5+ years’ experience in a supervisory/leadership capacity. Thorough understanding of Analytical Testing in a cGMP environment for Elisa, Bioassay, PCR and contaminants methods.
#IRELIM #JOBSIEST #LI-Onsite #REGNQC
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.