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Quality Control (QC) - Manager (GMP)

  • Quality
  • Full-time
  • Hyderabad, IN

Posted on April 17, 2024

PopVax is an Indian biotechnology company based in Hyderabad. We are funded via research agreements with the Gates Foundation and Vitalik Buterin’s 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 human-infecting pathogens in the betacoronavirus genus, including current and future strains of SARS-CoV-2, the virus which causes COVID-19.

We have seen up close that there are incredible capabilities in vaccine design, testing, and optimization just waiting to be unlocked that will enable us to pursue and perhaps even succeed at realizing wildly ambitious agendas such as ending TB, preventing future pandemics via broadly-protective vaccines, tackling the deadly scourge of antimicrobial resistance, eliminating debilitating degenerative diseases like multiple sclerosis, and curing fiendishly tricky chronic conditions such as ME/CFS and Long COVID. We are initiating multiple new vaccine programs this year to go after a number of these opportunities.

We are seeking a Quality Control (QC) Manager — GMP to join our team in Hyderabad (note: in-person only, we do not offer remote work) to play a key role across our programs. Responsibilities will include:

  • Working closely with the analytical method development team to translate and standardize their protocols into cGMP-ready STPs, including planning and performing method validation.

  • Training QC scientists on new analytical methods, as well as the associated data collection and analysis procedures.

  • Ensuring the highest levels of safety and environmental compliance within the department.

  • Enforcing high standards of ethical conduct and compliance with all relevant local and international laws, cGMP regulations, and guidelines.

  • Supervision and management of laboratory personnel and work schedules to maximise efficiencies.

  • Planning, execution, and oversight of daily QC activities including sample receipt, segregation, testing, and release in the context of both process development and cGMP production, across the Analytical, Molecular Biology, and Microbiology functional groups, as well as regular review of associated documentation for accuracy, and interpretation of results.

  • Planning, execution, and oversight of stability testing.

  • Writing and reviewing QMS-related documentation.

  • Participating in and/or leading OOS/OOL/OOT and other quality investigations under the QMS.

  • Developing a long-term capacity plan for the forecasted manufacturing schedule.

  • Training the manufacturing and quality teams on quality-related technical, behavioural, and ethical practices.

Candidates must have:

  • Master’s degree or PhD in Analytical Chemistry, Biochemistry, Microbiology, Biotechnology, or a related field, with 10+ years of experience in performing and managing the QC of biologics in a cGMP setting.

  • A deep understanding of quality standards and cGMP guidelines for biopharmaceuticals, including knowledge of the relevant regulatory requirements for QC assay validation.

  • Deep expertise in the preparation of cGMP-ready SOPs and STPs.

  • Expertise in the use of compendial methods for biopharmaceutical product testing in a cGMP environment.

  • Expertise in performing and documenting stability studies for biopharmaceutical products.

  • Expertise in performing and documenting instrument validation end-to-end.

  • A history of ethical leadership and team management in a fast-paced, innovative environment.

  • Excellent communication (written and oral) skills.

  • Excellent technical, logistical, and organizational problem-solving abilities.

  • A demonstrated ability to collaborate effectively across departments and with external partners.

  • A willingness to take up new technical and regulatory challenges.

This role will report to the Head of QC.

We offer very competitive compensation, comprehensive health insurance with the option to cover 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.