Lab Manager at Sanofi in Framingham, Massachusetts

Posted in Other 1 day ago.





Job Description:

Job title: Lab Manager



Location: Framingham, MA



About the Job



We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.


This position will oversee daily operations at the MA Biocampus Quality Control Microbiology lab. This includes daily and stability testing of commercial product and EMCU testing at the Framingham campus.


We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?



Main Responsibilities:






  • Overseeing daily operations of the quality control laboratory to ensure adherence to the committed scheduled plans


  • Establish and prioritize lab quality control objectives (D)






  • Maintaining his/her laboratory in compliance with the GMPs and quality control processes defined according to internal and external quality requirements and regulations






  • Ensuring the usage of validated methods in his/her perimeter and executing any validation/transfer protocol as receiving unit






  • Contribute to develop and implement protocol (eg for validation, transfer, investigation...) (A)







  • Managing and training laboratory staff, ensuring they follow best practices and safety guidelines.






  • Elaborate training programs (D)







  • Ensuring his/her laboratory staff is qualified to perform the testing execution by maintaining the lab qualification matrix






  • Conducting routine shopfloor of laboratory to identify improvement opportunities.






  • Ensuring accurate and timely testing of received samples according to his/her perimeter.






  • Advise on testing schedules and priorities (A)







  • Reviewing and approving laboratory test results and reports.






  • Decide on the approval of test results (D)



  • Maintaining laboratory equipment, by applying maintenance, qualification and calibration plans to ensure accuracy and reliability of lab activities.






  • Advise about equipment maintenance schedules (A)



  • Investigating on a timely manner and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs.






  • Providing support during regulatory inspections and audits by answering to requests related to his/her perimeter






  • Build remediation plans related to inspection readiness gaps, findings, deviations, ... (A)






  • Ensuring that his/her lab/facilities, lab instruments, are kept in a quality and safety status to ensure that they can be used appropriately.





About You




Skills and Experience



Experience





  • 5 years of experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements.





Skills





  • Ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement.






  • Strong leadership abilities to manage and motivate a team, ensuring high performance and adherence to quality standards.






  • Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements.






  • Proficiency in identifying issues and implementing effective solutions to resolve quality control problems.





Why Choose Us?



  • Bring the miracles of science to life alongside a supportive, future-focused team.


  • Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.


  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.


  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.




Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.


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