Microbiology Supervisor (QC Lab)

Millipore Corporation; St. Louis (MO); On-site; USD 77,000 - 116,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Other perquisites

Job summary

MilliporeSigma is seeking a Microbiology Supervisor to lead the GMP QC Microbiology department, ensuring compliance with ICH Q7 and 21 CFR for API testing. The role excludes visa sponsorship and requires US work eligibility.

You will oversee test methods, validations, tech transfers, CAPAs, and OOS/OOT investigations while managing a QC team of 8–10. Expect collaboration with audits and regulatory bodies to uphold quality standards.

Qualifications

• Bachelor's degree in microbiology, biochemistry, biology, or life sciences is required.

Responsibilities

• Oversee microbiological test methods, method validations, and tech transfers.
• Manage OOS/OOT investigations, deviations, and CAPAs.
• Conduct routine training on aseptic techniques and testing procedures.
• Supervise QC Microbiology team of 8–10 employees and ensure delivery of quality metrics.
• Oversee Environmental Monitoring and Bioburden/Endotoxin testing labs.
• Ensure timely product release by prioritizing lab testing schedules.
• Develop and implement quality systems and policies to improve product/ materials quality.
• Support client and regulatory audits.

Skills

Quality control

GMP

Analytical instrumentation

Laboratory software

Education

Bachelor's Degree in Microbiology, Biochemistry, Biology, or other Life Science discipline

Tools

Analytical instrumentation

Laboratory software

Job description

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.

Your Role

The Microbiology Supervisor leads the GMP Quality Control Microbiology department, ensuring full compliance with ICH Q7 and 21 CFR regulations for active pharmaceutical ingredient (API) testing. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Key responsibilities

• Oversee microbiological test methods, method validations, and tech transfers
• Manage OOS/OOT investigations, deviations, and CAPAs
• Conduct routine training on aseptic techniques and testing procedures
• Supervise, manage, and develop a QC Microbiology team of 8-10 employees, holding full accountability for meeting business quality performance metrics and KPIs
• Oversee the Environmental Monitoring Program and the Bioburden and Endotoxin Testing laboratories
• Manage and prioritize laboratory testing schedules to ensure all products are released in a timely manner
• Develop and implement programs to establish and maintain quality systems and product/service standards, while driving quality improvement initiatives and establishing policies, procedures, and methods to enhance product, material, component, process, and operational quality
• Support and participate in client and regulatory audits
• Interface with internal and external customers on a regular basis to communicate project status, resolve issues, and implement methods, techniques, and evaluation criteria for products and processes
• Perform other duties as required by management

Minimum Qualifications

• Bachelor's Degree in Microbiology, Biochemistry, Biology, or other Life Science discipline

Preferred Qualifications

• Master's degree in a Life Sciences discipline
• Experience as a Quality Control Supervisor or Manager at a Life Sciences organization
• In-depth knowledge of health authority (FDA, EMA) expectations for pharma/biotech bulk and finished product manufacturing, alongside microbiological testing requirements
• Proficiency with analytical instrumentation and laboratory software
• Comprehensive knowledge of ICH Q7, 21 CFR 210/211, USP, and EP pharmacopeia requirements
• Proven experience working in a highly matrixed organization, preferably within a GMP manufacturing environment
• Strong written and verbal communication skills, with a demonstrated ability to translate complex issues into straightforward, succinct explanations
• Advanced root cause analysis and problem-solving skills
• Strong computer skills, including proficiency in word processing and Quality Systems databases
• Subject matter expertise in aseptic principles and practices
• Strong understanding of microbiological methodology and laboratory techniques, specifically USP < 85>, USP < 61>, and USP < 62>

Salary and Benefits

Salary range for this position: $77,400 - $116,100 annually. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

• Health insurance
• Paid time off (PTO)
• Retirement contributions
• Other perquisites

Equal Employment Opportunity

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.