Downstream Processing Executive - R&D and GMP

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

Job summary

PopVax Private Limited in Hyderabad is seeking a detail-oriented professional for Production – Process Development and Manufacturing. You will perform downstream process development and manufacturing in a cGMP setting, ensuring high-quality documentation and QA compliance.

The role involves joining a team focusing on vaccines, nucleic acid-based products, and advanced delivery systems, with responsibilities spanning chromatography, TFF, and AKTA-like systems, while coordinating with QA/QC and

Qualifications

• Master’s or bachelor’s degree in pharmaceutical sciences, biology, biotechnology, or another life sciences field.
• 2+ years of experience in CROs, CDMOs, Biopharmaceuticals, Vaccines manufacturing.
• 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.
• Experience and expertise in executing multiple downstream unit operations not limited to IEX, AFC and HIC using Akta-like FPLC systems, TFF and terminal filtration.
• Be willing to work nights and weekends and multiple shifts.

Responsibilities

• Hands-on downstream operations including chromatography, filtration setups, and buffer preparation.
• Direct technical engagement across proteins, VLPs, mRNA and LNP formulations.
• Lead qualification and commissioning of downstream processing equipment in a cGMP environment.
• Identify operational bottlenecks and troubleshoot risks to prevent processing failures.
• Maintain control over raw materials and inventories for upcoming runs.
• Draft, refine, and review GMP documentation (BMRs, validation protocols, performance qualifications).
• Escalate deviations and change controls to QA with context and assessment.
• Drive root-cause investigations into manufacturing deviations or batch failures.
• Collaborate with QA, QC, and Engineering to prevent non-compliances and improve systems.
• Be ready to present data and answer questions about production activities within 30 seconds.
• Total understanding of documentation needs and continuity, driving continuous improvement.

Skills

Downstream PD

GMP documentation

Chromatography

Akta systems

cGMP regulations

QA/QC coordination

Team collaboration

English documentation

Education

MPharma/Bachelor in life sciences

Bachelor's in pharma/biotech

Tools

Akta-like FPLC

TFF

MS Office

Google Workspace

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 – Process Development and Manufacturing team. As a member, you will perform downstream process development and manufacturing activities at PopVax in Manufacturing and process development lab as well. You will always be 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.

• 2+ years of experience in CROs, CDMOs, Biopharmaceuticals, Vaccines manufacturing.

• 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.

• Experience and expertise in executing multiple downstream unit operations not limited to IEX, AFC and HIC using Akta-like FPLC systems, TFF and terminal filtration.

• Be willing to work nights and weekends and multiple shifts.

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.

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

Role Responsibilities:

• Hands-on execution of downstream operations including chromatography, filtration setups, and precision preparation of buffers, reagents, and auxiliary process components.

• Direct technical engagement across diverse therapeutic modalities, encompassing proteins, virus-like particles (VLPs), mRNA and lipid nanoparticle (LNP) formulations.

• Lead the qualification and commissioning of specialized downstream processing equipment within a cGMP environment.

• Proactively identify operational bottlenecks and troubleshoot technical risks well ahead of run execution to prevent processing failures.

• Maintain rigorous control over raw materials, reagents, and consumable inventories for upcoming manufacturing runs so production is never delayed.

• Draft, refine, and review essential GMP documentation, including BMRs, validation protocols, performance qualifications, and comprehensive technical reports.

• Promptly escape deviations, change controls, and operational anomalies to QA with thorough initial context and technical assessment.

• Drive root-cause investigations into manufacturing deviations or batch failures to implement effective, long-term corrective actions.

• Thrive in a collaborative environment with flexible shift coverage, maintaining unwavering commitment to Environment, Health, Safety, and Sustainability standards.

• 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.

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

• 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.