Production – Quality Management

PopVax Private Limited; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

PopVax Private Limited in Hyderabad, India, seeks a detail-oriented Quality Management professional for Production quality systems in a cGMP environment. You will translate R&D product requirements to safety and quality levels expected in GMP, focusing on vaccines and biologics.

Role emphasizes documentation, SOPs, and cross-functional collaboration with QA, QC, and engineering to ensure timely, compliant manufacturing and process improvements in a high-tech setting.

Qualifications

• Master’s or bachelor’s degree in pharmaceutical sciences, biology, biotechnology, or life sciences.
• Proficient in drafting SOPs, QMS docs, protocols, and reports in formal English.
• Sound understanding of basic statistical analysis.
• Proficient in Google Workspace and MS Office.
• Proactive, detail-oriented, and able to manage multiple tasks.

Responsibilities

• Oversee qualification and maintenance of Production facility and equipment; maintain a calendar of events and tasks.
• Coordinate with QA, QC, and Engineering to prevent non-compliances and improve processes.
• Maintain GMP BOM for housekeeping and batch activities; anticipate shortages at least 6 weeks ahead.
• Present data or answer management questions within 30 seconds of request.
• Manage staff assigned to regular and extraordinary activities with on-site presence as needed.
• Understand and improve documented processes; ensure up-to-date records and GMP compliance.
• Engage proactively with seniority, take ownership of facility and product quality.
• Do not say I don’t know; seek solutions and continuous improvement.
• Strive to improve cGMP practices and PopVax as a whole.
• Develop deep understanding of products and projects to enable seamless GMP integration.
• Be willing to learn and manage risk for equipment, processes, or projects.

Skills

SOPs & QMS drafting

Statistical analysis

Google Workspace

Attention to detail

Documentation management

Multitasking across tasks

Education

Bachelor's or Master's in pharmaceutical sciences/biology/biotechnology

Tools

Google Sheets

MS Office

Job description

About PopVax

PopVax is a clinical-stage, Indian full-stack biotech using generative AI to build first-in-class and best-in-class vaccines for infectious diseases, targeted cancer therapeutics, and personalized autoimmune therapies.

Our mission is funded by Vitalik Buterin’s Balvi Fund, the Gates Foundation, the US Biomedical Advanced Research and Development Authority (BARDA), Renaissance Philanthropy, and Good Ventures, with individual investments from Enveda founder Viswa Colluru and Tesla self-driving AI pioneer Dhaval Shroff.

We conduct our R&D work and GMP manufacturing at our integrated RNA Foundry in Hyderabad, India, in support of our Million Lives Mission to develop vaccines and therapeutics over the next decade with the potential to cumulatively save 1 million lives each year.

Our pipeline includes a broadly-protective COVID-19 vaccine, currently in a Phase I trial in Australia, first-in-class vaccines against Hepatitis C, Strep A and adult TB, as well as precision cancer therapies against pancreatic and liver cancer. We intend to take at least 5 novel vaccine and therapeutic candidates into clinical trials over the next two years.

About the Role

We are seeking a detail-oriented and proactive professional to join our Production – Quality Management team. As a member, you will play a key role in maintaining high standards of documentation and quality systems in a cGMP-regulated environment. We are not only looking for people comfortable working in the traditional GMP framework, but who can translate any R&D product to the safety and quality levels that cGMP would require.

This is a unique opportunity to work at the forefront of biologics manufacturing, with a focus on vaccines, nucleic acid-based products, and advanced delivery systems. Aside from vaccines, we have made substantial progress applying AI and high-throughput functional assays to the development of personalized generative medicines for cancer immunotherapy against hard-to-treat solid tumours such as liver cancer and pancreatic cancer, which kill >80% of patients within 5 years of diagnosis.

So, if you are someone who is wanting to expand their horizons, learn, plan and manage such first-of-its-kind projects, this job is for you.

The candidate should possess:

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

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

• Sound understanding of applied mathematical skills, including basic statistical analysis.

• Expertise in Google Workspace, specifically formula-enabled sheets and MS Office.

• A proactive learning attitude with high attention to detail.

• Ability to manage multiple documentation tasks accurately and efficiently.

The ideal candidate will possess:

• 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.

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

• Has a strong hold on how a batch is manufactured, how a facility is maintained and how documents flow.

Role Responsibilities:

• Not just oversee the regular qualification and maintenance of Production facility and equipment, but maintain a complete calendar of all events and tasks related to the Production facility equipment, such that you don’t ask the people, but people ask you what’s next?

• Not just coordinate with QA, QC and Engineering, but act as a glue and make them work in time, prevent non-compliances and make it better.

• Have complete control over the maintenance of GMP- bill of materials (BOM) for the housekeeping activities and batch related activities, such that we are never out of materials and are informed of any shortcomings at least 6 weeks before.

• Be a resourceful person who can present data or answer any random question related to Production activity within 30 seconds of management asking you.

• Manage the staff allotted to you for regular and extraordinary activities which may require your ground presence at any time in the clock and calendar.

• Handle not just document passing, but have a total understanding of whatever needs to be done, recorded and maintained and use that information to continually improve systems, without prompting.

• Have zero fear of seniority and ask the right questions at the right times, become an equal owner of the facility and not limit yourself to “your domain”, but do whatever it takes to uphold the facility and product at its best quality.

• Doesn’t say “I don’t know” for an answer.

• Never sits idle and always looks for ways to improve both professional self, cGMP practices and PopVax as a whole.

• Strong aptitude in knowing the science behind all the products and projects ongoing at PopVax, such that they can be inducted into the GMP facility seamlessly without delays.

• Willing to learn and handle risk management for an equipment, process, product or any project.

• Has the ability to stay on top of all things happening and get to the bottom of things.