Naisarg Pujara
Cosmetech Pty Ltd
Brisbane,Australia
Accomplishments
- Successfully commercialized 25+ human and veterinary pharmaceutical products and supported 80+ R&D formulations from lab to market.
- Led the ISO 9001 and ISO 22716 certification audit at Cosmetech to a full pass, strengthening GMP documentation and readiness across the business.
- Advanced thermostable MAP vaccine programs at Vaxxas from preclinical to clinical stages.
- Built and managed in-house R&D, QA, and analytical labs at Abbey Animal Health, cutting outsourcing costs by 30% and improving testing turnaround by 40%.
- Led formulation and stability programs fully compliant with TGA, GMP, GLP, and ICH standards across pharmaceutical, veterinary, and cosmetic products.
- Developed liposomal and nanoparticle delivery systems enhancing bioavailability and efficacy.
- Scaled formulations and production processes to support a 50% increase in production volume at Abbey Animal Health.
- Implemented innovation pipelines aligned with market trends and business growth objectives.
Skills
Product Development & R&D Leadership
Cosmetic & Pharmaceutical Formulation
Quality Assurance & Regulatory Compliance (GMP
GLP
APVMA
TGA
ICH
ISO 9001
ISO 22716)
Claims Substantiation & Regulatory Documentation
Stability & Compatibility Testing
Analytical Techniques (HPLC
LC-MS
SEM
TEM
VaxArray
TFF
Zetasizer)
Supplier & Raw Material Qualification
Cross-Functional & Cross-Departmental Leadership
Lab Setup & Team Management
Lean Six Sigma
Project Management
Sustainable & Cruelty-Free Product Development
HACCP
Certification
- HACCP Principles and Practices – Great Learning Academy
- Lean Six Sigma — Anexas Europe
- Leadership and Team Development — International Business Management Institute (IBMI), Berlin
- Project Management Foundations — LinkedIn Learning / Project Management Institute (PMI®)
- Drug Discovery, Design and Development — Alison
- Audit Preparation Training — PharmOut
- Zetasizer User Training, Particle Sizing — ATA Scientific
- People Management — MindLuster
12
Years of experience
R&D, Quality and Technical Operations leader with 10+ years across pharmaceuticals, veterinary health, vaccines and cosmetics. Currently head a cross-functional Product Development, Quality and Technical Operations function spanning three departments. Delivered 25+ commercialized products and 80+ R&D formulations from concept to market, with a track record of building in-house R&D/QA labs (30% cost reduction, 40% faster turnaround) and leading GMP/GLP/APVMA/TGA/ICH-compliant formulation and stability programs. PhD in Nanotechnology & Nanomedicine; hands-on expertise in HPLC, LC-MS, SEM, TEM, VaxArray and TFF.
Work History
Head of Product Development, Quality & Tech. Op.
9 Months- Lead product development, quality and technical operations together under one remit, giving senior leadership a single point of accountability for strategy and resourcing across all three departments.
- Direct formulation development from concept through pilot scale production, managing a team of 3 and an operational budget of over $1 million, while sourcing and evaluating raw materials and new ingredient technologies to keep products aligned with market trends and sustainability goals.
- Built and run stability, compatibility and efficacy testing programs that substantiated product claims and guaranteed shelf-life on every formulation that went to market.
- Led the ISO 9001 and ISO 22716 certification audit to a full pass, having first strengthened GMP readiness by reviewing and updating documentation across procedures, work instructions, batch records, forms, logbooks, templates and registers.
- Kept several operational workstreams moving at once by managing supplier quality agreements, testing partnerships, purchase order coordination and stock and packaging planning across 2 operational lines, while renegotiating supplier terms that cut analytical testing costs by 50%.
- Provided technical support across multiple customer-facing projects, including supplier follow up, formulation checks and production preparation, while partnering with marketing, sales and manufacturing to execute 8+ commercial product launches and mentoring 3 junior quality and production staff.
Research & Formulation Manager
2 Years 1 Month- 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 25+ 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.
- Conducted comprehensive stability studies, raw material qualification, and process validation.
Formulation Chemist
1 Year 1 Month- 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
2 Years 2 Months- 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
1 Year 6 Months- 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
3 Years 10 Months- 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.