Executive/Senior Executive Microbiology QC

PopVax is an Indian biotechnology company based in Hyderabad working at the frontier of translational biology.

We are funded via research agreements with the Gates Foundation and Vitalik Buterins biosecurity company Balvi.

For the past year, we have been building a novel second-generation mRNA platform for low-cost broadly-protective vaccines via computationally-driven antigen design, starting with an open-source booster vaccine candidate that is intended to protect against the entire sarbecovirus species and, if things go well, the betacoronavirus genus, including current and future strains of SARS-CoV-2, the virus which causes COVID-19 We are also beginning work on several other vaccine programs.

Were looking for an experienced microbiologist to aid our efforts in microbial testing for Quality Control.

Requirements.

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.

We offer very competitive compensation, comprehensive health insurance covering immediate family (including pre-existing conditions), and, most importantly, a collaborative work environment focused on solving the cutting-edge multidisciplinary challenges of our novel mRNA platform.