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Executive – Manufacturing Quality Compliance

  • Process Development and Manufacturing
  • Full-time
  • Hyderabad, IN

PopVax is an Indian full-stack biotech building first-in-class and best-in-class vaccines and cancer immunotherapies using machine learning-driven design and relentless empiricism. We design, develop, and manufacture our own RNA medicines end-to-end because we believe great pharmaceutical science can only flourish in tight feedback loops that iterate rapidly. PopVax’s experimental work and clinical dose production is based at the RNA Foundry, our integrated R&D and GMP-capable clinical dose production facility in Hyderabad.

PopVax's north star is our goal of developing novel vaccines and therapeutics over the next decade with the cumulative ability to save 1 million lives each year – the Million Lives Mission. To that end, we are developing first-in-class vaccines against Hepatitis C Virus, Strep A, and adult pulmonary TB, broadly-protective best-in-class vaccines against COVID-19, influenza, and HPV, and precision immunotherapies against hard-to-treat solid tumours such as liver cancer and pancreatic cancer.

Our work is funded by Vitalik Buterin’s Balvi Fund, the Gates Foundation, the US Biomedical Advanced Research and Development Authority (BARDA), and Renaissance Philanthropy. Our first vaccine program will begin a Phase I clinical trial in the US in mid-2026 conducted & sponsored by the National Institutes of Health (NIH). We intend to put 6 novel vaccines and immunotherapies into Phase I clinical trials over the next 3 years.

No matter the job title, each person’s role at PopVax is ultimately focused on helping take safe & effective new medicines that represent a step-change improvement on the current standard-of-care to the people who need them as fast as possible. If you want to work where the ambition is high, the learning curve is steep, and the work matters to billions, you’ll feel at home here.

If you’re excited by the idea of advancing scientific, clinical, and regulatory frontiers of vaccines and immunotherapies, spending each day developing medicines with the potential to save millions of lives, and building a generational global pharmaceutical company in India along the way – join us!

We have built and operationalised a small-scale GMP-capable mRNA foundry in Hyderabad to produce clinical doses for this trial, as well as others in our pipeline. We are looking to hire a new member for our Process Development & Manufacturing team to help adapt cutting-edge technologies from the lab to the rigours of a cGMP-compliant production process. 

All candidates must possess:

  • A master’s or bachelor’s degree in pharmaceutical sciences, biology, biotechnology, or any other life sciences field.

  • Proficiency in communicating and drafting documents such as SOPs, QMS documentation, protocols, and reports in formal English.

  • Strong applied mathematical skills, including basic statistical analysis.

  • A proactive learning attitude with high attention to detail.

  • Ability to manage multiple documentation tasks accurately and efficiently.

The ideal candidate will possess:

  • A minimum of 1 year of documentation experience in a cGMP environment within vaccines or other biologics is preferred. Specific experience with nucleic acid or nanoparticle-based products would be a significant advantage.

  • In-depth understanding of cGMP requirements and regulations, along with the core principles underlying them. Experience in drafting GMP SOPs, batch manufacturing records (BMRs), production reports, and other related documents.

  • Strong knowledge of pharmaceutical QMS principles, with direct experience in handling and documenting deviations, change control, CAPA, OOS, and OOT investigations.

Role Responsibilities:

  • Ensure that all manufacturing documentation activities comply with regulatory requirements, including Schedule M (India), ICH guidelines, US FDA cGMP, and other relevant standards.

  • Implement and maintain quality systems and procedures to ensure the accuracy, consistency, and compliance of documentation.

  • Continuously evaluate documentation processes to identify areas for improvement and develop strategies to enhance efficiency and quality.

  • Develop, execute, and document validation protocols in accordance with QA requirements. Prepare validation reports, investigation reports, root cause analyses, and conclusions.

  • Prepare, review, and update SOPs to enhance manufacturing and quality documentation systems. 

  • Manage and document deviations, change controls, Corrective and Preventive Actions (CAPA), Out-of-Specification (OOS), and Out-of-Trend (OOT) investigations.

  • Collaborate with Quality Assurance, Regulatory Affairs, and other departments to ensure accurate documentation supports product development, regulatory submissions, and business objectives.

  • Actively participate in internal and external audits by providing necessary documentation and ensuring compliance with regulatory expectations.

  • Apply basic statistical analysis to support investigations and reporting within the QMS documentation framework.

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.