Lab Manager - QC Microbiology EMCU

Job Title: Lab Manager - QC Microbiology EMCU

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. 

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