Prafulla Mali

About Prafulla Mali

Vaccine and biologics success is anchored in three fundamentals: passion, patience, and disciplined planning. Strong front-end strategy, rigorous program governance, and risk-based execution are essential for delivering scalable, compliant, and commercially successful products.Prafulla is a senior vaccine and biologics development leader with 25 years of experience across human and animal health. He has led complex, multi-platform programs from concept to commercialization, covering human, poultry, and veterinary vaccines, as well as advanced biologics.His leadership experience includes end-to-end ownership of:Portfolio strategy & business case evaluation, technology scouting, due diligence, partnerships, and alliance managementDefinition of Target Product Profiles (TPP) aligned with clinical, regulatory, and commercial objectivesDevelopment and scale-up of live attenuated, inactivated, recombinant, and viral-vector vaccines, including:Human vaccines: MMR, Rotavirus, Varicella, Japanese Encephalitis, Hepatitis A, IPV, Rabies, Zika, COVID-19Poultry & animal vaccines: Newcastle Disease (ND), Infectious Bursal Disease (IBD), Marek’s Disease (MD)Design of robust, scalable, and cost-effective DS & DP manufacturing platforms with integrated analytical and CMC strategiesProgram governance: budgeting, milestone management, risk assessment, and delivery against approved business plansBiotech facility design and greenfield/brownfield setup, including execution of Master Validation PlansTechnology transfer and operational readiness across R&D, MSAT, QA, QC, and manufacturingImplementation of enterprise quality systems aligned with ICH Q8, Q9 & Q10, enabling QbD-driven, risk-based decision makingOperational excellence through Lean, value-stream optimization, and continuous improvement frameworksPrafulla also brings strategic insight into next-generation biologics and platforms, including viral vector–based vaccines, AAV and lentiviral gene therapies, CAR-T cell therapies, adenoviral platforms, baculovirus–insect cell systems, and CHO-based recombinant proteins.Recognized for building high-performing teams, aligning scientific innovation with business priorities, and delivering compliant, future-ready vaccine and biologics portfolios, Prafulla continues to drive impact across global human and animal health ecosystems.

Experience

1. Dgm Viral Vaccine Production

   Bharat Biotech

   Oct 2023 — Present · Hyderabad, IN

   large scale Viral vaccine production/ scale up with new platform technologies viz. microcarriers, chromatographic purification. Operation and maintenance of BSL-3 containment facility

Education

• North Maharashtra University

  MSc., Industrial Microbiology

  1997 — 1999

• Jai Hindu jobs

  Microbiology (BSc), Microbiology

• School of life sciences, North maharashtra university

  Post Graduate studies, Microbiology; First Division

  1997 — 1999

Skills

• Sop
• Life Sciences
• Execution of Effective Validation Master Plan, Implementing Robust Systems
• R&D
• Biotechnology
• Validation
• Technology Transfer
• Fermentation
• Auditing
• Assay Development
• Lifesciences
• Purification
• Vaccines
• Cell Culture
• Cell
• Glp
• Gmp