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Downstream Processing - R&D and GMP

  • 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 and scale up cutting-edge technologies from the lab to the rigours of a cGMP-compliant production process. The ideal candidate will have a strong scientific background, preferably in a field such as molecular biology or nanoparticle formulation, as well as a solid understanding of GMP regulations and documentation. They should be comfortable working on the bench, either in the R&D lab or in the production facility, as needed. 

Role Responsibilities:

  • Work closely with R&D teams to adapt lab-scale protocols that underpin key production process steps across molecular biology, nanoparticle formulation, chromatography, and other related fields into SOPs for GMP-compliant dose production.

  • Help plan and participate directly in all aspects of manufacturing operations, including upstream processes, downstream processes, formulation, filling, packaging, and labelling, as well as the execution of process validation for these processes.

  • Participate in and perform fermentation of bacterial cultures, particularly E. coli, from flask level to mid-scale dedicated bioreactors and fermenters, including biomass separation and other upstream activities.

  • Participate in and perform mRNA IVT and nanoparticle formulation.

  • Participate in and perform purification processes, including chromatography using FPLC (AKTA-like systems), tangential flow filtration (TFF), and terminal filtration.

  • Ensure that all manufacturing activities comply with regulatory requirements, including Schedule M (Indian), ICH, US FDA cGMP, and other relevant standards. Implement and maintain quality systems and procedures to ensure product quality and safety.

  • Continuously assess manufacturing processes to identify areas for improvement. Develop and implement strategies to increase efficiency, reduce waste, and improve product quality. Implement best practices and benchmark performance against industry standards.

  • Participate directly in the maintenance and calibration of manufacturing equipment. Coordinate with maintenance and engineering teams to ensure that equipment operates effectively and that facilities meet regulatory standards.

  • Set up formula-enabled spreadsheets to represent comprehensive bills of materials (BOMs) for manufacturing processes, ensuring they can be rapidly adapted to any changes in manufacturing materials and techniques.

  • Manage inventory levels of raw materials, components, and finished products. Coordinate with procurement and supply chain teams to ensure adequate inventory levels while minimising excess inventory and waste.

  • Promote a culture of safety and compliance within the manufacturing facility. Ensure that all employees follow safety protocols and use appropriate personal protective equipment (PPE). Conduct regular safety inspections and audits to identify and mitigate potential hazards.

  • Collaborate with other departments, including Quality Assurance, Regulatory Affairs, Research and Development, and Supply Chain, to support product development, regulatory submissions, and overall business objectives.

  • Write and execute validation protocols for equipment, processes, and procedures according to QA requirements. Generate validation reports, investigation reports, root cause analyses, and conclusions.

The ideal candidate will possess:

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

  • A strong scientific background in one or more of molecular biology, nanoparticle formulation, and organic chemistry.

  • Strong applied mathematical skills, including basic statistical analysis.

  • 5+ years of production experience in a cGMP environment, with hands-on experience directly participating in production activities on the shop floor. Vaccines or other biologics experience is preferred, and specific experience with nucleic acid or nanoparticle-based products would be a significant advantage.

  • A deep understanding of cGMP requirements and regulations, as well as the core principles underlying them, and experience drafting GMP SOPs, BMRs, production reports, and other related documents.

  • A strong grasp of QMS principles, with direct experience handling and documenting deviations, change control, CAPA, OOS, and OOT investigations.

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.