Director of Microbiology

Pyramid Laboratories Inc•Costa Mesa, CA

About The Position

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 Pyramid Lab’s environmental monitoring program.

Requirements

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.
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

Nice To Haves

Drug Product Manufacturing Experience, within a CDMO/CMO (preferred)

Responsibilities

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 Pyramid Lab’s 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 Pyramid Lab’s 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.