PopVax is an Indian full-stack biotechnology company developing novel mRNA vaccines and therapeutics using computational protein design. Our first vaccine is a next-generation COVID-19 booster, which will enter a first-in-human Phase I clinical trial in the U.S. early this year. This vaccine is intended to broaden protection against both current and predicted future SARS-CoV-2 variants, reducing the possibility of a new mutation in the virus suddenly causing another massive wave of infection. We have a preclinical pipeline of 6 additional novel vaccine candidates built on our mRNA-LNP platform that we will be taking into clinical trials over the next few years. Our work to date has been funded primarily via project agreements totalling 10+ million USD with the Bill & Melinda Gates Foundation and Vitalik Buterin's public health & biosecurity organisation Balvi.

We have built and operationalized 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 rigors 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 labeling, 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 minimizing 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.