PopVax

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Senior Manager - Analytical

  • Quality
  • Full-time
  • Hyderabad, IN

2022-09-23 12:45:18 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 Quality Control manager to lead our efforts in analytical testing.

QUALIFICATIONS

  • 8+ years of experience in analytical testing for QC in a cGMP environment, ideally for vaccines in particular, across sample receipt, segregation, testing, analysis, documentation, reporting, and release

  • Experience with analytical techniques such as spectroscopy, chromatography, ELISA, and physico-chemical characterization, along with the calibration and operation of the relevant instruments

  • 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 analytical 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

  • Experience managing a cross-functional QC team including analytical and molecular biology personnel

  • Experience aligning the capacity and testing schedule of QC with the forecasted manufacturing schedule to ensure complete and timely results

  • 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.