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.
As a Senior Manager in QC a typical day might include, but is not limited to, the following:
- Coordinate with members of Manufacturing, Stability, and Business Ops to provide analytical support
- Manage QC Analysts, distribute work load, and monitor progress
- Oversee product testing to ensure efficient and compliant operations
- Review test reports
- Ensure QC Analysts receive proper training
- Attend meetings to keep informed of manufacturing priorities
- Ensure that safety standards are maintained
- Ensure compliance with applicable cGMP regulations and SOPs
- Investigate atypical and OOS test results as necessary
- Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory
- Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed
- Oversee QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness
- Track and coordinate major analytical investigation
- Track and monitor timeline of analytical validation projects
- Monitor the team performance for Compliance events, track, assist and organize continuous improvement event
- Interact with Regulatory Agencies as needed to ensure cGMP compliance
- Special projects as assigned
- Perform 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.