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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the 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. Key responsibilities include overseeing microbiological test methods, method validations, and tech transfers; managing OOS/OOT investigations, deviations, and CAPAs; and conducting 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
Who You Are
Minimum Qualifications
- ✓Bachelor's Degree in Microbiology, Biochemistry, Biology, or other Life Science discipline
- ✓3+ years of experience as a quality control manager, supervisor, or lead
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>
RSREMD
Salary range for this position: $85,500 - $136,000 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.
Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
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.