Regeneron is currently seeking an Associate Director for our Quality Control (QC) Technical Resources Chemistry team for in-coming component testing and functional testing for combination drug products. The Associate Director will be responsible for bringing new components, determining the qualification and testing strategy, the oversight of 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 an Associate Director, a typical day might include the following:
- Champions a culture of customer service for all internal and external clients.
- Lead a team of Mangers and QC Scientists, distribute work load, monitor progress, perform personnel management including development, feedback, and performance evaluations.
- Support filling operations for any technical support.
- QC method validation and transfer processes.
- Maintain open communications with scientist including internal, partner and contract manufacturing organizations.
- Provide direction to Managers and scientist that support the method development, validation and transfer processes.
- Coordinates with members of Process Sciences, Manufacturing, QC, Stability, and Business Ops to provide analytical support.
- Oversee Project Management of Method transfer and validations.
- Report progress monthly to upper management and reports any deficiencies.
- Reviews test reports when approving method validations and method transfers.
- Attends meetings to keep informed of manufacturing priorities.
- Ensures compliance with applicable cGMP regulations and SOPs, and safety standards are maintained.
- Oversee investigations atypical and OOS test results as necessary.
- Ensure monthly reports reporting Technical Resources status to upper management are delivered.
This role might be for you if:
- Looking to join a growing, fast moving dynamic team that supports other QC teams to achieve continued growth and success.
- You have extensive experience in in-coming component qualification and testing
- 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 for in-coming component testing and functional testing for combination drug products, method validations, method transfers, regulatory filings and regulatory inspections.
To be considered for the Associate Director - QC Technical Resources you must have a BS/BA in Science, Engineering, or related discipline, with 10+ years of experience in the pharmaceutical or biotech industry. Previous management experience is required. Experience in raw material testing and drug product testing is preferred but not 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)