Thirunavukkarasu Angappan

Vice President - Operations & Manufacturing @ PopVax

About

Biologics and vaccine manufacturing, for me, has never been just about production metrics — it is about building resilient systems that reliably deliver life-saving vaccines and biologic therapies at global scale. With over 25 years of leadership in GMP-regulated vaccine and biologics manufacturing across viral, bacterial, recombinant, conjugate, and mRNA platforms, I have focused on aligning operational execution with enterprise growth strategy. My work sits at the intersection of scientific rigor, regulatory governance, financial discipline, and long-term value creation. I began my career in Quality Control and Quality Assurance, developing a deep respect for GMP integrity, WHO inspection readiness, and risk-based compliance frameworks. Those early years — spanning India's most respected vaccine organisations including Shantha Biotec, Biological E, Indian Immunologicals, and Panacea Biotec — shaped my belief that sustainable scale is built on disciplined systems, a strong quality culture, and empowered teams. Over time, I transitioned into full P&L site leadership, overseeing ₹100+ Cr annual operations and leading 300+ cross-functional professionals across production, quality, engineering, supply chain, and support functions. The results speak clearly: → Delivered 100% capacity expansion — scaling from 20M to 40M doses → Achieved 75% yield improvement in Hepatitis B manufacturing → Reduced cost of goods by ~20% through systematic operational efficiency → Sustained WHO Prequalification and CDSCO compliance across all audit cycles with zero critical observations → Institutionalised KPI-driven governance, embedding performance accountability across all functions Currently, as VP – Operations & Manufacturing at PopVax, I am leading the establishment of a GMP-compliant mRNA manufacturing platform from concept to clinical-stage readiness — integrating infrastructure build-out, digital manufacturing systems, capex governance, and cross-functional execution to create future-ready biologics capability. I am a firm believer that world-class manufacturing is not built by systems alone — it is built by people who understand why standards exist and take ownership of them. My leadership philosophy is rooted in that conviction: develop the team, strengthen the system, deliver the result. I am particularly drawn to enterprise leadership roles — CXO, SVP Operations, or Site Head — where operational scalability, regulatory excellence, and long-term public health impact converge within globally expanding biologics and vaccine organizations.

Country

India

City

Hyderabad

Industry

Biotechnology

Skill

GLP, Vaccines, Sop, GMP, CAPA, Biotechnology, Validation, Pharmaceutical Industry, Biopharmaceuticals, Technology Transfer, Regulatory Affairs, V&V, HPLC, Quality System, FDA, ELISA, Microbiology, Cleaning Validation, Purification, Toxicology

Experience

Vice President - Operations & Manufacturing

PopVax

2022-7 - Present · 4 yrs 3 mos

Hyderabad

• Served as Factory Manager, leading brownfield establishment of a 12,000 sq. ft. GMP-compliant mRNA vaccine manufacturing facility from concept to operational readiness within 12 months. • Directed facility design, cleanroom zoning, biosafety layout, and installation of critical utilities including HVAC, WFI systems, and controlled cold-chain infrastructure aligned to GMP standards. • Led procurement, installation, and full lifecycle qualification (DQ/IQ/OQ/PQ) of key manufacturing and QC systems including sterilization, chromatography, biosafety cabinets, centrifuges, and controlled storage systems. • Established GMP documentation frameworks, validation master planning, environmental monitoring systems, and quality governance structures supporting regulatory compliance. • Played a key leadership role in securing CDSCO and State Licensing Authority approvals, obtaining CT-10 and Form 29 test manufacturing licenses. • Drove process scale-up, optimization, and successful execution of PCT and Clinical Trial batches of mRNA COVID-19 vaccine. • Chaired the Institutional Biosafety Committee (IBSC) and strengthened biosafety governance across mRNA operations. • Supported in-vivo studies through CRO partnerships, ensuring compliant preclinical evaluation and development support. • Integrated cross-functional teams across Engineering, QA, Regulatory, R&D, and Supply Chain to establish a fully operational clinical-stage mRNA platform.

Site Head

Panacea Biotec

2012-1 - 2022-6 · 10 yrs 6 mos

Lalru, India

• Held full accountability for biologics manufacturing site operations including production, quality, engineering, utilities, warehouse, HR, IT, and animal facilities. • Managed ₹100 Cr annual budget and 300+ workforce; statutory Factory Manager. • Expanded capacity from 20M to 40M doses; improved Hepatitis B yield by 75%. • Delivered ~20% cost reduction and improved turnaround by 10–15%. • Led WHO PQ & CDSCO inspections with minimal observations. • Chairman – IAEC; Member – IBSC. • Reinforced Quality Management Systems for bulk vaccine manufacturing. • Elevated GMP compliance maturity and audit readiness. • Implemented structured deviation, CAPA, and risk-based quality frameworks.

Manager III

Indian Immunologicals Limited

2010-6 - 2011-12 · 1 yr 7 mos

Hyderabad Area, India

• Strengthened in-vivo governance and biosafety frameworks supporting a broad vaccine portfolio across Livestock (Foot-and-Mouth Disease, Hemorrhagic Septicemia, Black Quarter, Bluetongue, Enterotoxaemia, PPR, Brucellosis, Porcine Cysticercosis) and Companion Animal vaccines (Rabies, Canine Distemper, Adenovirus, Parvovirus, Parainfluenza, Leptospirosis, Coronavirus). • Established and standardized in-vivo potency models and biological reference systems for key viral and bacterial vaccines (Rabies, FMD, Sheep Pox, Tetanus Toxoid, Diphtheria, Hepatitis B) ensuring compliant batch release and regulatory robustness. • Contributed to manufacturing and regulatory readiness across Human vaccines (Rabies, Pentavalent – DPT+Hep B+Hib, Hepatitis B recombinant, Tetanus Toxoid, Td, Measles-Rubella, Hepatitis A) strengthening audit preparedness and inspection confidence. • Optimized GLP-compliant animal facility operations, enhancing utilization efficiency, compliance systems, and cross-platform vaccine development support.

Manager - QC

Biological E. Limited

2007-2 - 2010-5 · 3 yrs 4 mos

Hyderabad, Telangana, India

• Supervising the In-vivo group in Biological E - Sera & Vaccine Division. • Animal House Management, Planning and procurement of animals, Health Evaluation & Health • Monitoring of Lab animals, In-vivo tests (like safety and Potency tests), Method qualification studies of potency tests, Stability studies of vaccines and sera, Development of In-house standards for vaccines, Optimization of potency tests etc.

Asst. Manager -AH

Shantha Biotechnics Limited

2001-1 - 2007-1 · 6 yrs 1 mo

Hyderabad, Telangana, India

• Established an ~18,000 sq. ft., 24-room GLP-compliant in-vivo facility, building institutional testing and development capability. • Led end-to-end animal house operations, in-vivo potency/safety testing, stability studies, and compliant batch release support across vaccine platforms. • Instituted biological reference standards and strengthened viral and bacterial testing protocols. • Managed IAEC governance, ensuring ethical compliance, biosafety adherence, and regulatory alignment. • Partnered with R&D to enable in-vivo development and platform validation programs.