PopVax

PopVax (https://popvax.com) is delighted to announce 1.15 million USD in funding from the Bill & Melinda Gates Foundation for the development of thermostable mRNA delivery formulations composed of novel lipids and polymers designed by PopVax. Maunish Barvalia, our VP of Platform Technologies, is leading this project for us. The mRNA vaccines approved in the United States and Europe require storage temperatures of between -20 °C and -80 °C, which puts them out of reach of developing countries without extensive supply chains that are able to maintain those below-freezing temperatures. Our new delivery formulations are intended to be stable at normal refrigerator temperatures while retaining their potency across a range of routes of administration. If we succeed, we will be able to rapidly distribute new mRNA vaccines and therapeutics to combat infectious diseases all over the world, rather than just in rich countries. The Gates Foundation was our very first external funder when we started out, and we’re thrilled to deepen our collaboration with them. The press release can be found here: https://lnkd.in/dPsbwyGp

PopVax is hiring a Junior Scientist or Scientist to work on Toxicology & ADME studies. As our first program moves into the clinic, we are beginning preclinical work on a variety of novel mRNA vaccines and therapeutics in parallel. 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 these 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. Apply here: https://lnkd.in/dRFwPxPp

PopVax is hiring in Quality Assurance (QA) for our GMP facility in Hyderabad, as we adapt and scale up our cutting-edge technologies from the lab to the rigours of a cGMP-compliant production process. Our technology platform and programs are evolving fast, but it is our legal and, more importantly, moral responsibility to ensure that we are able to translate lifesaving vaccines and therapeutics into the clinic as rapidly as possible without ever sacrificing the safety of the patients we hope to serve across the world. As the Hippocratic Oath taken by physicians exhorts – first, do no harm. This applies no less to us, and as vaccine developers making pharmaceuticals that will be taken by potentially billions of healthy individuals, we have a special responsibility to ensure that we take every step we can conceive of to minimize the risk to those who choose to place their trust in our products. Quality Assurance is an essential part of this – they serve as crucial interlocutors who question, at every point, whether things are as they should be, placing themselves in the difficult position of, in many cases, opposing their own colleagues and management in service of the health and safety of those who will be on the other end of the needle. We seek to hire individuals who meet the highest ideals of this occupation. All applicants for QA positions at PopVax must have: - 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.  - The willingness to read, understand, absorb, and apply key primary sources of regulatory information such as the ICH guidelines, 21 CFR (US), and Schedule M (India), allied with a keen eye for detail. - Excellent problem-solving, organizational, and communication skills. - Strong applied mathematical skills, including basic statistical analysis. - The willingness and ability to learn quickly and adapt to rapid changes in a fast-paced environment. First, and most time-sensitive, we are hiring a Trainee in QA to start immediately, no later than within one month from now: https://lnkd.in/dhtjKtqC Second, we are looking to hire a more experienced QA person to serve as an Executive or Senior Executive focusing on QMS & Documentation: https://lnkd.in/dHphm5kH

PopVax is hiring a Scientist for our Quality Control (QC) team to perform Bioassays on our mRNA vaccines and therapeutics, including transfection into mammalian cells, ELISA, Western Blot, and gel electrophoresis, as well as compendial assays such as BET/LAL. Expertise in cell culture and cell-based assays is essential, and the ideal candidate will have some knowledge of molecular biology, preferably including experience in the use of qPCR-based methods for nucleic acid quantification. If you think you're a good fit for this role, please apply here: https://lnkd.in/dq8Wxg-N

PopVax is hiring a Quality Control Manager (GMP) to lead day-to-day quality control (QC) activities related to the cGMP production of our mRNA-LNP vaccines and therapeutics. We are looking for someone with deep expertise in the execution and cGMP-compliant documentation of diverse QC protocols and procedures, a strong track record of training and managing QC teams in a fast-paced environment, and, most importantly, unshakeable ethical principles. If you think you are a good fit for this role, please apply here: https://lnkd.in/dgmSstgH

PopVax is hiring an Analytical Scientist - HPLC, ideally with LC-MS experience as well (https://lnkd.in/dhwf4EjH), with a particular focus on analytical method development, as we move towards clinical trials for our novel mRNA-LNP vaccines and therapeutics. The ideal candidate will have experience in the development of HPLC-based methods, and preferably LC-MS methods as well, but will also have a broad base of knowledge across chemistry and molecular biology, with the ability to pick up new information as needed to understand the biochemical basis of the methods, protocols, and assays we need to develop. Prior experience in method development for nucleic acid products, including mRNA and DNA, or related cell & gene therapy (CGT) products, as well as in the use of HPLC-CAD for lipid nanoparticle characterization, would be substantial advantages.

PopVax is substantially expanding our analytical sciences team, with a particular focus on analytical method development, as we move towards clinical trials for our novel mRNA-LNP vaccines and therapeutics. We are hiring a Senior or Principal Scientist, Analytical Method Development (https://lnkd.in/d87TJCM2) who will lead a team to develop cutting-edge analytical methods for the nucleic acids, delivery vehicles, proteins, and peptides that make up the multi-component biopharmaceuticals we work on. We're looking for someone who is just as comfortable adapting novel techniques from academic publications to our application domain as they are writing precise, cGMP-ready protocols and performing rigorous method validation. The ideal candidate will have deep expertise in the development of HPLC-based methods, and preferably LC-MS methods as well, but will also have a broad base of knowledge across chemistry and molecular biology, with the ability to pick up new information as needed to understand the biochemical basis of the methods, protocols, and assays we need to develop. Prior experience in method development for nucleic acid products, including mRNA and DNA, or related cell & gene therapy (CGT) products, as well as in the use of HPLC-CAD for lipid nanoparticle characterization, would be substantial advantages. If you believe you are a good fit for the position, please apply below ASAP -- we are looking to move quickly on this.