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 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 cutting-edge technologies from the lab to the rigors of a cGMP-compliant production process. 

All candidates must possess:

• A master’s or bachelor’s degree in pharmaceutical sciences, biology, biotechnology, or any other life sciences field.

• Proficiency in communicating and drafting documents such as SOPs, QMS documentation, protocols, and reports in formal English.

• Strong applied mathematical skills, including basic statistical analysis.

• A proactive learning attitude with high attention to detail.

• Ability to manage multiple documentation tasks accurately and efficiently.

The ideal candidate will possess:

• A minimum of 1 year of documentation experience in a cGMP environment within vaccines or other biologics is preferred. Specific experience with nucleic acid or nanoparticle-based products would be a significant advantage.

• In-depth understanding of cGMP requirements and regulations, along with the core principles underlying them. Experience in drafting GMP SOPs, batch manufacturing records (BMRs), production reports, and other related documents.

• Strong knowledge of pharmaceutical QMS principles, with direct experience in handling and documenting deviations, change control, CAPA, OOS, and OOT investigations.

Role Responsibilities:

• Ensure that all manufacturing documentation activities comply with regulatory requirements, including Schedule M (India), ICH guidelines, US FDA cGMP, and other relevant standards.

• Implement and maintain quality systems and procedures to ensure the accuracy, consistency, and compliance of documentation.

• Continuously evaluate documentation processes to identify areas for improvement and develop strategies to enhance efficiency and quality.

• Develop, execute, and document validation protocols in accordance with QA requirements. Prepare validation reports, investigation reports, root cause analyses, and conclusions.

• Prepare, review, and update SOPs to enhance manufacturing and quality documentation systems. 

• Manage and document deviations, change controls, Corrective and Preventive Actions (CAPA), Out-of-Specification (OOS), and Out-of-Trend (OOT) investigations.

• Collaborate with Quality Assurance, Regulatory Affairs, and other departments to ensure accurate documentation supports product development, regulatory submissions, and business objectives.

• Actively participate in internal and external audits by providing necessary documentation and ensuring compliance with regulatory expectations.

• Apply basic statistical analysis to support investigations and reporting within the QMS documentation framework.

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.