Burlington, Massachusetts, USA
1 day ago
Laboratory Manager - Extractables and Leachables

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 


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).

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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.

 

 



What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

 

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