Sanofi
Job title:
Lab Manager - QC Microbiology - Operations Location:
Framingham, MA Come join the QC Microbiology Lab in Framingham as a lab manager for QC Micro operations! 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. Our team: The Quality Control team is dedicated to the development and validation of methodologies using state of the art technology and responsible for ensuring that all production lots and materials meet the required quality standards, supporting regulatory compliance, and operational excellence of the organization 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
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 use of validated methods in his/her perimeter and executing any
validation/transfer protocol as receiving unit
Managing and training laboratory staff, ensuring they follow best practices and safety guidelines
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
Reviewing and approving laboratory test results and reports
Maintaining laboratory equipment by applying maintenance, qualification, and
calibration plans to ensure accuracy and reliability of lab activities
Ensuring the follow-up and progress of the investigations, change control, and CAPAs assigned to his/her perimeter, in a timely manner
Investigating in 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
Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately
Key Roles: Establish and prioritize lab quality control objectives (D)
Contribute to develop and implement protocol (e.g., for validation, transfer, investigation) (A)
Elaborate training programs (D)
Advise on testing schedules and priorities (A)
Decide on the approval of test results (D)
Advise about equipment maintenance schedules (A)
Build remediation plans related to inspection readiness gaps, findings, deviations (A)
Additional Responsibilities: Ability to perform tasks in a Quality Control Laboratory environment. May be required to enter controlled environments following proper gowning protocols.
About You Basic Qualifications Bachelor’s degree in a Life Sciences discipline with 6+ years of experience in a cGMP laboratory environment, OR Master’s degree in a Life Sciences discipline with 4+ years of experience in a cGMP laboratory environment Experience in Analytical Method Development and Validation Technical Experience: Demonstrated ability to manage scientific projects, oversee personnel, and present technical data effectively Proficient in scientific and technical writing, including authoring and revising SOPs and technical reports Skilled in troubleshooting assay and equipment issues Preferred Qualifications Proven experience leading technical teams in Analytical Development Experience with lab-based data management and quality systems Familiarity with USP and global compendia requirements Experience in technical writing, investigations, and root cause analysis In-depth knowledge of cGMP, ICH, USP, and global compendia regulations and guidance, particularly as they relate to method development and validation Working Hours: Monday-Friday 8:30 AM -5:00 PM
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. #GD-SG #LI-GZ #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can
be found here.
#J-18808-Ljbffr
Lab Manager - QC Microbiology - Operations Location:
Framingham, MA Come join the QC Microbiology Lab in Framingham as a lab manager for QC Micro operations! 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. Our team: The Quality Control team is dedicated to the development and validation of methodologies using state of the art technology and responsible for ensuring that all production lots and materials meet the required quality standards, supporting regulatory compliance, and operational excellence of the organization 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
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 use of validated methods in his/her perimeter and executing any
validation/transfer protocol as receiving unit
Managing and training laboratory staff, ensuring they follow best practices and safety guidelines
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
Reviewing and approving laboratory test results and reports
Maintaining laboratory equipment by applying maintenance, qualification, and
calibration plans to ensure accuracy and reliability of lab activities
Ensuring the follow-up and progress of the investigations, change control, and CAPAs assigned to his/her perimeter, in a timely manner
Investigating in 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
Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately
Key Roles: Establish and prioritize lab quality control objectives (D)
Contribute to develop and implement protocol (e.g., for validation, transfer, investigation) (A)
Elaborate training programs (D)
Advise on testing schedules and priorities (A)
Decide on the approval of test results (D)
Advise about equipment maintenance schedules (A)
Build remediation plans related to inspection readiness gaps, findings, deviations (A)
Additional Responsibilities: Ability to perform tasks in a Quality Control Laboratory environment. May be required to enter controlled environments following proper gowning protocols.
About You Basic Qualifications Bachelor’s degree in a Life Sciences discipline with 6+ years of experience in a cGMP laboratory environment, OR Master’s degree in a Life Sciences discipline with 4+ years of experience in a cGMP laboratory environment Experience in Analytical Method Development and Validation Technical Experience: Demonstrated ability to manage scientific projects, oversee personnel, and present technical data effectively Proficient in scientific and technical writing, including authoring and revising SOPs and technical reports Skilled in troubleshooting assay and equipment issues Preferred Qualifications Proven experience leading technical teams in Analytical Development Experience with lab-based data management and quality systems Familiarity with USP and global compendia requirements Experience in technical writing, investigations, and root cause analysis In-depth knowledge of cGMP, ICH, USP, and global compendia regulations and guidance, particularly as they relate to method development and validation Working Hours: Monday-Friday 8:30 AM -5:00 PM
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. #GD-SG #LI-GZ #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can
be found here.
#J-18808-Ljbffr