About PopVax
PopVax is a clinical-stage, Indian full-stack biotech building first-in-class and best-in-class vaccines for infectious diseases, targeted cancer and infectious disease therapies, and personalized autoimmune therapies using generative AI for protein design. We have been funded by the Gates Foundation, the US Biomedical Advanced Research and Development Authority (BARDA), Vitalik Buterin, and Good Ventures.
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 hiring a Head of Quality Control to establish and lead a rigorous, fast and transparent Quality Control function for our clinical-stage programs. You will be accountable for the QC laboratory’s operations and readiness: how samples are managed, tests are performed and reviewed, methods enter routine use, investigations are conducted, and the team is trained.
You will work closely with Quality Assurance, Analytical Development, Manufacturing, Process Development, and Regulatory Affairs. The role requires strong GMP QC leadership and the judgment to build the processes, culture and technical depth that let PopVax move quickly without compromising data integrity or product quality.
Responsibilities
Set QC strategy, laboratory priorities, staffing plans and performance measures for the laboratory.
Establish traceable sample workflows, from request and receipt through storage, testing, review, and reporting.
Work with Analytical Development to bring methods into QC. Ensure methods are fit for their intended use and appropriately transferred, verified, qualified, or validated before routine use.
Establish and maintain controls for specifications, stability testing, reference standards, reagents, instruments, calibration, maintenance, and laboratory documentation.
Ensure results are reviewed promptly and consistently, with clear escalation of unexpected or potentially significant findings.
Lead or provide QC technical leadership for investigations into out-of-specification (OOS), out-of-trend (OOT), and other atypical results. Work with Quality Assurance on root-cause analysis, corrective and preventive actions, and follow-up.
Maintain data-integrity practices and appropriate controls for electronic records and systems, including 21 CFR Part 11 where applicable.
Recruit, coach, and develop QC leaders and analysts. Establish training and qualification pathways that build sound laboratory judgment.
Partner with Quality Assurance and other functions on manufacturing support, release testing, deviations, change controls, stability programs, and regulatory commitments.
Represent QC in audits and inspections, and use findings to improve laboratory systems.
Minimum Qualifications
Bachelor's, Master's, or PhD in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Microbiology, or a related field.
10+ years of relevant industry experience (5+ years for PhD holders), including significant experience leading GMP Quality Control operations.
Strong understanding of GMP requirements and international regulatory standards, including FDA, EMA, and ICH guidelines.
Experience managing QC laboratories, including analytical testing, method transfer and validation, stability studies, and batch release testing.
Demonstrated experience managing OOS/OOT investigations, deviations, CAPA, change controls, and root-cause investigations.
Strong technical understanding of analytical methods, including HPLC/UHPLC, spectroscopy, and relevant biochemical and microbiological assays.
Experience with data integrity (ALCOA+), electronic laboratory systems, and regulatory inspections.
Proven ability to lead multidisciplinary QC teams, manage laboratory operations, and maintain high standards of scientific rigor and documentation.
Experience with novel therapeutic modalities, including mRNA vaccines, lipid nanoparticles, recombinant proteins, radiopharmaceuticals, ADCs, or cell and gene therapies.
Preferred Qualifications
Experience establishing or scaling GMP QC laboratories, including equipment qualification, staffing, and laboratory systems.
Experience supporting clinical-stage programs, including developing phase-appropriate specifications and analytical control strategies.
Familiarity with advanced analytical techniques, including LC-MS/MS, capillary electrophoresis, qPCR/ddPCR, and cell-based potency assays.
Experience overseeing QC microbiology, including environmental monitoring, sterility, bioburden, and endotoxin testing.
Experience implementing LIMS, chromatography data systems, and other digital QC workflows.
Experience working in integrated R&D and GMP manufacturing environments, particularly where products and analytical methods evolve rapidly.
Pay and Benefits
We pay in the top 1% for comparable roles in India, and your exact salary will depend on your skills, experience and qualifications. You'll also receive stock options, and we'll help you relocate to Hyderabad. Our comprehensive health insurance covers you, your spouse and your children, including pre-existing conditions, and you can add your parents. You'll also get accidental and term insurance, and free access to doctors 24x7.