PopVax is an Indian biotechnology company based in Hyderabad which is building a next-generation mRNA platform for broadly-protective vaccines via computationally-driven antigen design and a novel delivery platform, starting with a betacoronavirus vaccine candidate that will enter clinical trials in the US this year.

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. 

As our first program moves into the clinic, we are beginning preclinical work on a variety of novel mRNA vaccines and therapeutics in parallel. As such, we are seeking a highly motivated and detail-oriented researcher to plan, coordinate, and supervise ADME (Absorption, Distribution, Metabolism, and Excretion) studies, including biodistribution, and GLP toxicology studies for PopVax’s novel mRNA vaccine and therapeutic candidates – we expect we will be preparing up to 5 such candidates for IND next year. This is a unique opportunity to operate on the frontier of our understanding of the physiological impact of cutting-edge protein design and nucleic acid modalities.

Key responsibilities will include:

• Designing in vitro and in vivo toxicology and ADME studies aligning with relevant scientific and regulatory standards, in particular those that apply in India, the United States, Europe, and ICH jurisdictions broadly – this also requires staying current with changes in these guidelines and requirements.

• Writing and reviewing complete study protocols for toxicology and ADME studies.

• Analyzing toxicokinetic and pharmacokinetic data to assess safety profiles for our vaccine and therapeutic candidates, and preparing detailed reports to communicate these findings to internal and external stakeholders.

• Preparing and formatting toxicology and ADME data for IND filings. 

• Collaborating cross-functionally with R&D, Regulatory Affairs, Quality Control, and Quality Assurance to conduct and document studies. 

• Instructing, coordinating with, and reviewing the work of Contract Research Organizations  (CROs) engaged to execute toxicology and ADME studies.

Necessary qualifications:

• Hands-on experience writing and reviewing protocols for in vivo toxicology and/or ADME studies.

• A strong conceptual understanding of haematology, clinical chemistry, histopathology, and immunohistochemistry.

• Hands-on experience working with mice and rats in the context of toxicology and ADME studies.

• Knowledge of regulatory guidelines and requirements for toxicology and ADME studies for novel molecules, ideally across Indian, US, European, and ICH jurisdictions.

• Strong proficiency in written and spoken English, in particular the ability to write, proofread, and edit complex technical documents from scratch.

• Extensive experience with using one or more of Microsoft Office (Word & Excel) and Google Docs (Docs & Sheets), including advanced features such as version control (Track Changes), the use of custom formulae, and pivot tables. 

• Excellent problem-solving, organizational, and communication skills.

• Strong applied mathematical skills, including basic statistical analysis, in particular hypothesis testing, as well as basic proficiency in data visualization.

• The willingness and ability to learn quickly and adapt to rapid changes in a fast-paced environment.

• A drive to see projects through to completion.

The ideal candidate will also have:

• Experience with IVIS.

• Exposure to analytical techniques such as LC-MS/MS and qRT-PCR.

• Exposure to bioassays like ELISA, Cytometric Bead Array, and MSD.

• Previous engagement in communications and/or negotiations with CROs.

• Relevant industry experience in a reputed CRO working on toxicology and ADME studies.

• Some knowledge of molecular biology and formulation development.

• Experience participating in meetings with regulators such as the US FDA.