Sr Manager Quality Control

Within this role you will oversee a team involved in laboratory quality control testing,  and has technical responsibility for all 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, distributes work load, and monitors progress

Managing product testing to ensure efficient and compliant operations

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 a typical and OOS test results as necessary

Managing transfers internally from R&D to the QC laboratory or from PAS to the QC Laboratory

Managing transfers externally from QC laboratory to contract labs, includes audits if needed

Managing QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness

Tracking and monitoring the timeline of analytical validation projects

Monitoring the team performance for Compliance events, track, assist and organize continuous improvement events

Interacting with Regulatory Agencies as needed to ensure cGMP compliance

Performing personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations

This role may be for you if you:

Contribute to special projects as assigned

Demonstrate strong coordination during major analytical investigations

Review and approve test reports for accuracy and compliance

To be considered for this role, you should have a Bachelor’s degree (BS/BA) in Chemistry or Biology, along with relevant experience in a pharmaceutical or biotechnology environment, particularly in laboratory management and analytical sciences. Relevant experience may be accepted in lieu of formal qualifications.

Education and Experience:

Manager : Minimum 7+ years of experience

Sr Manager: Minimum 8+ years of experience

#IRELIM #JOBSIEST #LI-Onsite

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.

Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.