Lab Services Manager

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:

Responsible for managing Quality Control lab services supporting the laboratory and external clients.  Internal services include QC training program, QC method transfer and stability program, QC data review, QC system Admin support, and management of internal QC projects.  External support includes managing projects for clinical and commercial drug products and providing technical communication to clients regarding these drug products on behalf of the QC Laboratories. 

• Responsible for the management and output of the QC data reviewers (Qualified Scientists), Stability Coordinator, QC Training team, and QC Systems team.
• Responsible for the management and output of the QC Validation team that performs QC method validations, transfers, and client support.
• Responsible for QC data integrity and the oversight of QC electronic data capture systems (Empower, Nugenesis, etc).
• Identify and drive operational and compliance improvements in the QC laboratory, track, and report improvement progress.
• Represent QC laboratory in a technical expert capacity on analytical and microbiological methods and laboratory investigations in communications with clients and internal Operations, QC Validation group Support, Quality Assurance and Technical Support departments.
• Lead and manage data integrity related deviations and OOS investigations within the laboratory for new development or later phase clinical drug products. Communicate with clients the status of these investigations.
• Develop, write and revise GMP documentation for method qualification protocols, raw material, in-process and finished drug product test specifications, analytical and microbiological methods, validation master plans etc. This may also include management of change controls for QC projects.
• As a part of the employee’s job requirements, the employee may handle wastes including hazardous wastes. 
• Responsible for Environmental, Health, and Safety compliance.
• Participate in regulatory inspections of the facility (e.g. FDA, MHRA, ANVISA) and customer inspections of the facility.

Who You Are:

Minimum Qualifications:

• Bachelors Degree in Chemistry or Microbiology.
• 7+ years of experience in quality control supporting GMP/GLP manufacturing operations.
• 4+ years of leadership experience.
• 2+ years of method validation experience. 

Preferred Qualifications:

• Experience with analytical methods for a wide range of sample types (chromatographic including the various detector types, spectroscopic, physical etc).
• Experience with cGMPs and pharmaceutical QC quality systems.

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