PopVax

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Senior Manager - Microbiology

  • Quality
  • Full-time
  • Hyderabad, IN

2022-09-23 12:23:12 UTC

PopVax is an Indian biotechnology company based in Hyderabad building a novel thermostable, low-cost, and safe second-generation mRNA platform for rationally-designed broadly-protective multi-epitope vaccines. We’re starting with a 4-8 °C refrigerator-stable booster vaccine candidate that is intended to protect against the entire sarbecovirus sub-family, including current and future strains of SARS-CoV-2 (the virus which causes COVID-19), and some other beta-coronaviruses such as MERS-CoV.

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

QUALIFICATIONS

  • 8+ years of experience performing microbiology testing for QC in a cGMP environment, ideally for vaccines in particular

  • 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

  • Deep 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

  • 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 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, devations, incident investigations, and other elements of quality management systems

  • Demonstrated experience recruiting, training, and managing a team succesfully in a fast-paced cGMP enviroment

  • 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.