PopVax, an Indian biotechnology company based in Hyderabad, with a primarily remote US subsidiary nominally located in New York, is seeking a senior regulatory executive. The company is funded through research agreements with the Gates Foundation and Vitalik Buterin's biosecurity company, Balvi. Over the past year, PopVax has been developing a novel second-generation mRNA platform for low-cost broadly-protective vaccines using computationally-driven antigen design. The primary focus is on an open-source booster vaccine candidate designed to provide protection against the entire sarbecovirus species and potentially the betacoronavirus genus, including current and future strains of SARS-CoV-2, the virus responsible for COVID-19. Clinical trials for this candidate are planned to commence later this year. The ideal candidate for this role should possess deep expertise in the end-to-end qualification of novel vaccines and biologics in the US, navigating FDA processes from preclinical development to animal trials, GMP manufacturing, human trials (IND), and licensure (BLA). Additionally, experience with regulatory processes in other stringent regimes such as the European Union (EMA), Canada (Health Canada), the UK (MHRA), and Japan (PMDA) is highly desirable. The candidate should be comfortable working independently in a fast-paced environment without immediate support from a regulatory team or junior regulatory executives. Previous experience in regulatory work for a successfully-authorized COVID-19 vaccine in any of these countries would be a significant advantage. The position offers the flexibility to work remotely from any country worldwide (except those sanctioned by the US in ways detrimental to the role). PopVax provides competitive compensation, comprehensive health insurance covering immediate family members (including pre-existing conditions), and a collaborative work environment dedicated to addressing the cutting-edge multidisciplinary challenges associated with the novel mRNA platform.,
As a Manager - IP at PopVax, an Indian biotechnology company based in Hyderabad, your role involves: - Drafting, filing, and prosecuting patent applications across multiple jurisdictions, including India, the US, and Europe - Providing assessments and opinions on patent validity/invalidity, patentability, and freedom-to-operate - Identifying FTO issues proactively and developing risk mitigation strategies - Managing outside counsel work related to patent prosecution and contested proceedings - Conducting patentability, freedom-to-operate, validity/invalidity, & state-of-the art searches, including bio-sequence searches, and preparing search reports - Performing infringement analysis and preparing claim charts and maps - Interacting with multidisciplinary teams involving R&D, Manufacturing, Clinical, and Regulatory, and advising on IP issues Qualifications and Skills required for this position: - A Masters degree in biotechnology or a similar field is required - A patent agent qualification and/or law degree are preferred but not mandatory - 5-8 years of core experience in drafting and prosecution in biotechnology or life sciences domain - Experience handling contested proceedings is preferred, but not mandatory - A good understanding of US and European patent laws - The ability to work well in a team as well as independently pursue tasks and projects when necessary, without close supervision - Complete fluency in English, with excellent oral and written communication skills, and an eye for detail - The ability to work in a highly-demanding and dynamic environment under challenging timelines PopVax is a unique Indian biotechnology company that operates at the forefront of protein design and nucleic acid therapeutics. The team at PopVax, led by industry experts, is focused on developing novel biomedicines to save lives and revolutionize translational biology research. Joining the IP team at PopVax presents an opportunity to work on cutting-edge technology, define IP strategy, and manage a growing patent portfolio in a collaborative and challenging environment. The company offers competitive compensation, comprehensive health insurance, and a collaborative work environment dedicated to solving multidisciplinary challenges in mRNA platform technology.,
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. 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 organization Balvi. We are seeking an Applied Statistician to join our team in Hyderabad (note: in-person only, we do not offer remote work) to play a key role across our programs. Responsibilities will include: Collating and processing diverse, unstructured biological and chemical data produced by PopVax's scientific teams on a daily basis Performing basic statistical analyses such as t-tests, ANOVA, Pearson and Spearman correlations, and generating brief markdown reports Producing data visualisations to fit specific requests Liaising with PopVax's scientific teams to improve and optimize data reporting methods and formats The Ideal Candidate Will Have Thorough theoretical understanding of Probability and Statistics A degree in Statistics, Data Science, Applied Mathematics or a similar quantitative field Excellent proficiency with R or Python Familiarity using R packages such as dplyr, ggplot2 and shiny or Python packages such as pandas, scipy, matplotlib, seaborn and plotly At least 2 years of experience with data processing and visualisation A demonstrated ability to produce clean data reports and visualisations especially using markdown-based tools like Rmd and Quarto A willingness to handle relatively large volumes of unstructured and poorly annotated data, working quickly on often-tight deadlines Basic understanding of machine learning techniques such as regression, decision trees, clustering and dimensionality reduction We offer very competitive compensation, comprehensive health insurance covering 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.
As a computational protein designer at PopVax, you will play a crucial role in utilizing various protein design and engineering techniques to contribute to the development of novel mRNA vaccines and therapeutics. Your responsibilities will include: - Utilizing protein design techniques such as brute force mutation, molecular dynamics simulations, ML-based approaches like constrained hallucination, in-painting, and diffusion, and protein language models for sequence optimization. - Collaborating with software engineers and machine learning scientists to enhance productivity. - Contributing to the open culture of publication for methods and encouraging independent research agendas alongside company goals. To qualify for this role, you should possess the following qualifications: - Experience in using computational tools to design or engineer proteins. - Familiarity with state-of-the-art machine learning methods. - Proficiency in writing code to develop and train models. PopVax, an Indian full-stack biotechnology company, is focused on developing broadly-protective vaccines against pandemic potential pathogens. The company has received funding from the Bill & Melinda Gates Foundation and Balvi for its projects. Remote work options are available for highly qualified candidates, with periodic site visits to the Hyderabad lab. Academic partnerships and part-time appointments can also be negotiated for candidates wishing to maintain ties with academia. If you believe you have the requisite background knowledge and skills to contribute to PopVax's mission of ensuring global access to innovative medical solutions, we encourage you to apply and elaborate on your relevant experience in the application. Join us at PopVax and be a part of the team working towards developing next-generation vaccines for broader protection against infectious diseases.,
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.