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 next 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.

We have built and operationalized a small-scale GMP-capable mRNA-LNP production setup in Hyderabad to produce clinical doses for this trial, as well as others in our pipeline. We are looking for exceptional candidates to help us improve and optimize the cutting-edge processes involved, as well as help us scale up our production capacity from thousands to millions of doses per year. This is a unique opportunity to operate at the frontier of nucleic acid production as we translate R&D into the clinic and beyond at an unprecedented pace.

PopVax was founded by Soham Sankaran, and our research work has been funded primarily via research agreements with the Bill & Melinda Gates Foundation (India) & Vitalik Buterin's Balvi. The team includes a former founding employee of Moderna and some of India's top experts in mRNA, lipid nanoparticle (LNP) formulation, and protein engineering. Our small but growing production and quality teams are staffed by veterans of Shantha Biotech (Sanofi India), Panacea Biotec, Biological E, the Serum Institute of India, and other pioneering Indian vaccine companies. 

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, ideally in a field like molecular biology or nanoparticle formulation, as well as a solid understanding of GMP regulations and documentation, and will have no problem working on the bench either in the R&D lab or in the production facility as needed. Our technology platform and programs are evolving fast, and no one is going to write detailed tech-transfer reports everytime something new comes in from R&D – it will be up to you to work with the relevant scientific teams to figure out what is going on and put it into the necessary structure for process development and execution.

Role Responsibility:

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

2. Help plan & participate directly in all aspects of manufacturing operations, including upstream process, downstream process, formulation, filling, packaging, and labeling, including perform process validation for these processes. 

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

4. Participate in and perform mRNA IVT and nanoparticle formulation.

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

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

7. 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.

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

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

10. 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.

11. 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.

12. 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.

13. Write and execute validation protocols for equipment, protocols, and processes according to QA requirements. Generate validation reports, investigations reports, root cause analysis and conclusions.

The ideal candidate will possess:  

• A master’s degree in a pharmaceutical, biology, biotech, 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 shopfloor – 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, and direct experience handling and documenting Deviation, Change Control, CAPA, OOS and OOT investigations.