Director QC Microbiology
186890
Posted: 24/02/2026
- $180,000.00 to $200,000.00
- Costa Mesa United States
POSITION SUMMARY:
The Director, Microbiology, is accountable for developing and overseeing the implementation of the Contamination Control Strategy including disinfectant efficacy, aseptic processes and techniques, and microbial method validations within a Drug Product Manufacturing Facility. The incumbent collaborates with multiple stakeholders to ensure the execution of contamination control policies across all functions.
Additional responsibilities include leading the day-to-day operations of the Microbiology Laboratory, setting the direction of the Microbiology Laboratory operations, and developing and overseeing environmental monitoring program.
Fully Onsite - Costa Mesa, CA
PRINCIPAL DUTIES:
QUALIFICATIONS:
The Director, Microbiology, is accountable for developing and overseeing the implementation of the Contamination Control Strategy including disinfectant efficacy, aseptic processes and techniques, and microbial method validations within a Drug Product Manufacturing Facility. The incumbent collaborates with multiple stakeholders to ensure the execution of contamination control policies across all functions.
Additional responsibilities include leading the day-to-day operations of the Microbiology Laboratory, setting the direction of the Microbiology Laboratory operations, and developing and overseeing environmental monitoring program.
Fully Onsite - Costa Mesa, CA
PRINCIPAL DUTIES:
- Accountable for the implementation and lifecycle management of the Contamination Control Strategy.
- Conduct risk assessments and develop mitigation strategies to minimize the risk of contamination, identifying potential sources of contamination and developing strategies to mitigate the risk.
- Lead the Sterility Assurance program including aseptic process simulations, drug product sterility testing, endotoxin, and bioburden testing, testing of utilities and environmental monitoring testing.
- Provide guidance on aseptic processing for all aseptic area personnel and apply best aseptic practices and associated international aseptic processing regulations. Promote the continuous improvement in aseptic technique culture/behavior.
- Provide technical support and Subject Matter Expert input for manufacturing-related process improvements, change control, deviation investigation, and CAPA implementation. Support problem-solving during testing and for unexpected test results, working collaboratively with all stakeholders and management as needed.
- Develop and perform aseptic training and operator qualification program.
- Direct the day-to-day Microbiology testing activities ensuring compliance with cGMP and safety regulations. Ensure that Microbiology staff are adequately trained and are performing tests per method procedures.
- Development and management of the Environmental Monitoring Program and disinfectant efficacy program.
- Perform EM trend analysis and evaluation of critical system data,
- Oversee and manage contract laboratories related to the microbiology lab.
- Support inspection readiness plans and interact with regulatory agencies during inspections on matters related to Contamination Control and Sterility Assurance.
QUALIFICATIONS:
- Substantial in a leadership role within the pharmaceutical or biotechnology industry.
- Strong knowledge of microbiological testing including drug product sterility, endotoxin, aseptic process simulations, and sterile manufacturing sterility investigations.
- Drug Product Manufacturing Experience, within a CDMO/CMO (preferred)
- Bachelor’s degree or higher in Life Sciences, Microbiology, Chemistry, or a related field
- 8+ years of relevant experience in commercial biotechnology or pharmaceutical production environment.
- Demonstrated knowledge of cGMP/ICH/FDA/EU compliance regulations and USP and EP monographs for microbiology
- Strong familiarity with USP <1211> Sterility Assurance, USP <71> Sterility Testing, and FDA Guidance for Industry - Sterile drug products
- Knowledge of Biosafety Level (BSL) requirements and use of risk assessment for the selection of appropriate microbiological practices
- Comprehensive knowledge of global GMP regulatory requirements for Aseptic Controls
- Knowledge and familiarity with Annex 1
- Excellent oral and written communication skills with strong technical writing experience
Ella Katz
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