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 a Executive/Senior Executive - QA Validation 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:

• Preparing protocols and schedules for qualification & requalification of our facility, equipment & utilities.

• Cross functional coordination with other PopVax department for execution of qualifications & validations (Facility, Utility & Equipment).

• Preparation & review of qualification protocols and trend reports.

• Preparation & review of qualification reports and master validation plan.

• Participation in deviation investigations to identify the root causes and define corrective and/or preventative actions.

• Managing regulatory queries and responses from regulatory agencies, collaborators, and other interested parties.

• Working with the rest of the QA team to ensure PopVax’s adherence to both the company’s internal protocols and to generally accepted Good Manufacturing Practices (as well as cGMP) procedures, along with regulatory (ISO, PDA, EU-GMP, WHO and 21 CFR guidelines) and safety regulations within the plant

• Participation in the development of any validation programs needed to remain current with cGMPs and industry standards.

Candidates should have:

• B. Pharm/B. Sc. or higher from an accredited institution

• Minimum 2 years of experience in a Quality Assurance role, preferably in the biotechnology and/or pharmaceutical industry, with proven expertise in validating and qualifying facilities and instruments to meet current global cGMP guidelines.

• Proficiency in written and spoken English is required.

This role will report to the Head of Quality Assurance.

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.