Naisarg Pujara
Brisbane,Australia
Summary
Innovative R&D and Formulation Manager with 10+ years of experience in pharmaceuticals, vaccines, veterinary, and consumer health. Expert in turning scientific ideas into market-ready products using HPLC, LC-MS, SEM, TEM, VaxArray, and TFF. Skilled in leading teams, setting up labs, and ensuring GMP, GLP, APVMA, TGA, and ICH compliance. Delivered 20+ successful product launches through strategic, collaborative leadership. Professionally trained in Lean Six Sigma, Leadership and Team Development, Project Management, Drug Discovery, and Audit Preparation, blending technical expertise with business insight to drive innovation and sustainable growth.
Accomplishments
- Successfully commercialized 20+ human and veterinary pharmaceutical products and supported 75+ R&D formulations from lab to market.
- Advanced thermostable MAP vaccine programs at Vaxxas from preclinical to clinical stages.
- Built and managed in-house R&D, QA, and analytical labs, reducing outsourcing costs and improving turnaround.
- Led formulation and stability programs fully compliant with TGA, GMP, GLP, and ICH standards.
- Developed liposomal and nanoparticle delivery systems enhancing bioavailability and efficacy.
- Implemented innovation pipelines aligned with market trends and business growth objectives.
Skills
- Product Innovation & R&D
- Sustainable Formulation Development
- Technical Troubleshooting
- Regulatory & Quality Compliance (GMP/GLP/APVMA/TGA/ICH)
- Analytical Techniques & Data Accuracy (HPLC, LC-MS, SEM, TEM, VaxArray, TFF)
- Stability Studies & Technical Documentation
- Advanced Statistical & Experimental Analysis
- Marketing & Commercialization Strategy
- Project & Team Leadership
- Cross-Functional Collaboration
Certification
- Lean Six Sigma, Anexas Europe.
- Leadership and Team Development, International Business Management Institute (IBMI), Berlin, Germany.
- Project Management Foundations, LinkedIn & PMI.
- Drug Discovery, Design and Development, Alison.
- Audit Preparation Training, PharmOut.
- Zetasizer User Training Course Reliable Particle Sizing, ATA Scientific.
Overview
11
11
years of professional experience
Work History
Research & Formulation Manager
Abbey Animal Health Pty Ltd
12.2023 - Current
- Lead a cross-functional team of R&D, QA, analytical and production teams, directing the full product lifecycle from concept to market launch.
- Drove successful commercialization of 20+ veterinary products, optimizing formulations and scaling processes to meet a 50% increase in production volume over the last year.
- Established and managed in-house R&D and QA laboratories, resulting in a 30% reduction in external outsourcing costs and a 40% faster turnaround time for critical analytical testing.
- Ensure adherence to GMP, GLP, CAPA, and regulatory frameworks, supporting APVMA audit readiness.
- Conducting comprehensive stability studies (ICH-compliant), raw material qualification, and process validation to enable scalable manufacturing for high volume products.
- Implemented operational strategies to enhance efficiency and staff training programs for improved team performance.
Formulation Chemist
Abbey Animal Health Pty Ltd
11.2022 - 12.2023
- Engineered and scaled veterinary and pharmaceutical products, achieving full GMP compliance.
- Developed and optimized formulations with ICH-compliant stability and compatibility studies.
- Authored regulatory documentation and supported APVMA submissions for timely market approvals.
- Collaborated with QA, supply chain, and production teams to troubleshoot and improve product performance.
Pre-clinical Scientist
Vaxxas Pty Ltd
09.2020 - 11.2022
- Spearheaded MAP (microneedle) vaccine delivery programs, advancing thermostability profiles and enabling progression of a key vaccine candidate from preclinical to Phase I clinical stages.
- Validated and performed GLP/GMP-compliant analytical testing (HPLC, BCA, VaxArray, TFF), ensuring data accuracy for CMC sections and regulatory filings.
- Coordinated 5+ cross-functional teams (Formulation, QA/QC, and Regulatory) to achieve critical preclinical and clinical trial milestones on schedule.
- Conducted stability assessments and raw material qualification to ensure supply chain reliability.
Senior Research Technician
UQ Diamantina Institute
02.2019 - 08.2020
- Formulated liposomal vaccine and drug compositions to improve bioavailability and stability.
- Conducted ICH-compliant stability studies and QC testing for preclinical research.
- Optimized cellular assays and molecular protocols for nanomedicine and cancer research.
PhD Researcher
UQ School of Pharmacy
01.2015 - 11.2018
- Developed nanoparticle-based oral drug delivery systems to enhance solubility and bioavailability.
- Conducted in vivo pharmacology studies, in vitro assays, and comprehensive nanoparticle characterization.
- Authored scientific publications, regulatory-aligned reports, and grant documentation.
Education
PhD - Nanotechnology & Nanomedicine
University of Queensland
Brisbane, Australia11.2018
Master of Pharmacy - Pharmaceutics
Gujarat Technological University
Rajkot, India05.2013
Bachelor of Pharmacy - Pharmacy
Saurashtra University
Rajkot, India07.2011