Laboratory Manager - Extractables and Leachables at Millipore Corporation in Burlington, Massachusetts

Job Description:

Work Location: Burlington, Massachusetts
Shift: No
Department: LS-PS-PVOUC Validation Services E&L Lab US
Recruiter: Genie Hooper



This information is for internals only. Please do not share outside of the organization.




Your Role:



At MilliporeSigma, we are seeking a dynamic and results-oriented Laboratory Manager for our Extractables and Leachables (E&L) team within the North American Validation Services group. The successful candidate will lead a diverse team of scientists, specialists, and assistants, ensuring the delivery of compliant testing services that align with business objectives. The ideal candidate will have a strong background in laboratory management, excellent organizational and interpersonal skills, and a commitment to safety and compliance.

• Manage laboratory staff and processes, setting clear expectations, fostering a collaborative environment, and driving continuous improvement initiatives.


• Monitor laboratory capacity, manage budgets, and maintain equipment and facility standards.


• Build and develop teams, drive engagement, and implement improvement solutions.


• Ensure adequately trained staff are available for project and laboratory work.


• Provide oversight and/or manage the inventory program for resources needed for successful laboratory operations and testing.


• Provide support to the testing laboratory's support functions and staff such as calibration and sample receipt. Will ensure a backup is available for these functions.


• Review test protocols and reports as well as other test-related documentation including data produced by the Laboratory to ensure it is complete, accurate, and compliant.


• Track laboratory trends using analytics, data reporting and visual management to display clear, relevant, harmonized metrics. Actively manage these to targets.


• Maintain Equipment ensuring it is safe and fit-for-purpose. This includes but is not limited to assuring it is validated, qualified, calibrated, maintained and reliable.


• Maintain the facility, engaging site facilities management, the site safety team, and outside vendors as necessary.


• Perform standard and non-standard Extractables and Leachables testing.


• Monitor BMS and equipment monitoring systems.


• Write test protocols, reports, and other test-related documentation.

Who You Are




Minimum Qualifications:

• Bachelor's Degree in a science discipline (e.g, Chemistry, Pharmaceutical, Biochemistry, etc.)


• 3+ years of experience in analytical chemistry with a strong focus on E&L testing within the pharmaceutical or medical device industry


• 2+ years of experience in laboratory leadership roles (ex. Team Lead or Supervisor).

Preferred Qualifications:

• Master's Degree in a scientific discipline (e.g, Chemistry, Pharmaceutical, Biochemistry, etc.).


• 3+ years of Managerial experience in a multidiscipline fast paced analytical chemistry laboratorie.


• Experience with laboratory electronic systems, including but not limited to: Gagetrack, LIMS, ELN, BMS, ECM, Mass Hunter etc.


• Strong working knowledge of Validation Services operational systems such as, but not limited to: Mango, Trackwise, SFDC, Sharepoint, LabVantage and Oracle.


• Excellent communication skills, both verbal and written.


• Excellent Extractables and Leachables Technical knowledge.


• Excellent knowledge of good laboratory practices, cGMP, regulatory guidance, and recommendations as well as demonstrable operational management abilities.


• Demonstrated troubleshooting competencies.


• Demonstrated ability to manage change and implement improvement solutions.


• Proven experience in developing, implementing, and monitoring performance against KPIs.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. Apply Now