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.
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 Healthcare India), Panacea Biotec, Biological E, the Serum Institute of India, and other pioneering Indian vaccine companies.
We are looking to hire a trainee to grow our Quality Assurance (QA) team 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 train someone who meets the highest ideals of this occupation – who by putting every fibre of their being into ensuring that what happens on the production floor matches what is on the page, down the to the last word, number, and punctuation mark, that any deviations are caught and corrected and documented with alacrity, that they withstand any pressure from anyone to yield to factual and moral compromises… we seek to train someone who by doing all of these things, and more, proves themselves worthy of this sacred trust.
The ideal candidate will possess:
A master’s degree in a pharmaceutical, biology, biotech, or other life sciences field.
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.
The ability to join immediately – that is, within no later than one month of 22 July 2024.
Over time, as the person hired into the role learns the fundamentals of Quality Assurance and is entrusted to carry out critical work, responsibilities will grow to include:
Development, review, and maintenance of QA documentation, including Standard Operating Procedures (SOPs), work instructions, protocols, reports, and other quality-related documents.
Ensuring all QA documents are current, accurate, and compliant with regulatory and company standards.
Coordination of document requisition approval processes and management of document control systems.
Conducting regular audits/verifications of QA documentation to ensure compliance and identifying areas for improvement.
Providing training and support to staff on document control processes and QMS requirements.
Collaborating with cross-functional teams, including QC, Manufacturing, Warehouse, Engineering and Regulatory Affairs, to ensure alignment and compliance.
Assisting in preparing for regulatory inspections and audits, providing necessary documentation and support.
Maintenance of electronic and physical archives of QA documents, ensuring easy accessibility and retrieval.
Creating, implementing and management of change control processes for QA documentation.
Participating in continuous improvement initiatives related to documentation practices and quality systems (Deviations, Change Controls, CAPA and Risk Assessments etc.).
We offer very competitive compensation, comprehensive health insurance with the option to cover 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.