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. 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 the environmental monitoring program.
Responsibilities
- Accountable for the implementation and lifecycle management of the Contamination Control Strategy
- Conduct risk assessments and develop mitigation strategies to minimize 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 Expertise input for manufacturing-related process improvements, change control, deviation investigation, and CAPA implementation; support problem-solving dung 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 the 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 experience 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
- 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
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