Regeneron is looking for a Senior Manager for our Quality Control (QC) Technical Resources Chemistry team for in-coming component testing and functional testing for combination drug products including visual inspection of in-coming components as well as drug product. In this position you will be responsible for the QC method validation of the methods for incoming components including visual inspection, functional testing and compendia testing, and method transfer to or from other internal sites, partners companies, and contract manufacturing companies.
As a Sr. Manager a typical day might include:
• Perform assay development and validation for incoming components including visual inspection, functional testing and compendia testing.
• Review new test procedures and assays.
• May evaluate and bring in new methodologies/techniques when needed.
• Facilitate assay transfer from R&D to business partners.
• Organize analytical assay transfer internally and externally.
• Participate in technical troubleshooting and problem investigation.
• Review analytical development report, assay and process validation report and
other technical documents for technical correctness and regulatory compliance.
• Performs personnel management functions including time sheet approvals,
scheduling of vacations, employee development, and employee evaluations.
This role might be for you if:
- Looking to join a growing, fast moving dynamic team that supports other Quality Control teams to achieve continued growth and success.
- Creative problem solver, effective communicator, goal and milestone motivated.
- High achiever in a dynamic and changing environment.
- Have experience working with cross-functional teams for analytical development, support and challenges.
- Extensive experience in method validations, method transfers, regulatory filings and regulatory inspections.
To be considered for this position, you must have a BS/BA in Science, Engineering, or related discipline, with 8+ years of experience working in a GMP lab, including 2+ years of management experience. Advanced degree preferred.
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)