Jobs at PopVax

We’re looking for an experienced microbiologist to aid our efforts in microbial testing for Quality Control.

• Perform microbiological quality control testing in a cGMP-compliant laboratory environment.
• Prepare and maintain master cell banks and working cell banks for intended applications.
• Conduct cell bank characterisation of microbial and mammalian cell lines.
• Perform cell passaging, viability testing, staining, cell counting, and sub-culture activities.
• Prepare microbiological culture media and perform sterility testing.
• Execute environmental monitoring programmes, including settle plate monitoring, area swabbing, and personnel monitoring.

• MSc in microbiology or a related life-sciences field.
• 4+ years of experience performing microbiology testing for QC in a cGMP environment, ideally for vaccines in particular
• Experience in cell banking and preparation of master and working cell banks for intended purposes.
• Experience in cell bank characterization of microbial and mammalian cell lines.
• Well versed with cell passaging, viability, staining techniques, cell counting, sub-culture activities.
• Knowledge on disinfectant techniques, cleanroom practices and maintenance, gowning practices.
• Well-versed in media preparation, sterility testing, EMP monitoring, and personnel monitoring
• Extensive experience in the microbial testing of water samples and in-process samples, as well as preservative efficacy studies and disinfectant validation
• Experienced in the operation and validation of instruments like autoclaves, microscopes, cell counters, and particle counters
• Experience with techniques for the identification of a broad spectrum of bio-contaminants, including bacteria and fungi
• Experience with biowaste management, de-contamination, cleaning and DHS activities in a manner compliant with all relevant laws and regulations
• Strong background in data management and analysis, with the ability to independently find, keep track of, and report on relevant trends in QC results
• Experience planning and ensuring comprehensive and approriately-controlled sample collection for environmental monitoring such as via settle plates, and for MLT and pathogens via a variety of modalities, including water collection, area swabs, and personal monitoring such as finger-dabbing.
• Deep knowledge of global guidelines on analytical method validation, US 21 CFR Part 11 compliance related to microbiology testing, and test plans to ensure data quality objectives
• Experience working with outsourced testing providers for microbiology work, including understanding of the necessary documentation to provide to and receive from each such outsourced provider
• Experience with investigations into OOS, OOL, OOT, and other types of quality incidents
• Ability to maintain operational and GMP readiness of the QC areas
• Exposure to and participation in regulatory audits, ideally for all of CDSCO/DCGI, WHO, and US FDA
• Ability to conceptualize, write, follow, and train others on SOPs for QC testing using methods derived from both compendial and non-compendial sources
• Experience dealing with change controls, deviations, incident investigations, and other elements of quality management systems
• Willingness to work any shift required, including night shifts, based on project requirements
• Exceptional oral and written communication skills