Santosh Thorat
Senior Scientist @Phillips Medisize
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WORK HISTORY
Senior Scientist @Phillips Medisize
Chippenham, GB
Strategized & executed project from early development to technology transfer of multi-dose complex Drug device combination DPI Para IV development. Directed the formulation and analytical teams on agile product development with Design control, and participated in high-level problem-solving sessions and technical discussion sessions to accelerate development- Development of LGWP pMDI formulation for global market •- Directed QBD-Design Control based Triple & Double combination (LAMA-LABA-ICS DPI, ICS-LABA DPI) complex multi-dose DPI formulation-device development program with In vitro- In vivo studies (PK-PD) for US, Europe.• Technical documentation of drafting and review of study protocol reports, Risk assessments, and Pharmaceutical development reports.• Guiding formulation and analytical scientists and mentoring for the daily formulation, process and analytical development activities. • Applying understanding of Q3 characterization to MDI-DPI such as Realistic breathing profile, Dissolution, MDRS to improve IVIVC understanding
EDUCATION
NIPER HYDERABAD
Master of Science (MS) Pharm, Pharmaceutical Sciences
SGRS College of pharmacy, Saswad
Bachelor's Degree, B. Pharmacy
ABOUT SANTOSH THORAT
Passionate Pharmaceutical Development (CMC) Team Leader with over 13 years of experience leading multidisciplinary teams in the development and commercialization of various dosage forms, including Metered Dose Inhalers (MDI), Dry Powder Inhalers (DPI), Nebulizers (Sterile), Nasal Sprays, and Solid Oral formulations across US, Europe, and ROW markets.• Experienced in leading oral solid-liquid formulation development projects across the entire lifecycle, including tablets, capsules, suspensions, solutions, and gels. Proficient in budgeting, risk assessment, development, scale-up, process optimization, and timely submission of dossiers to regulatory agencies• Strong expertise in designing and developing complex drug-device products with Quality by Design (QbD) and design control compliance for respiratory drug delivery.• Skilled in implementing cutting-edge Design of Experiment (DOE) methodologies to optimize formulation and process development, benchmark performance, and enhance product quality.• Recognized for expertise in all stages of formulation development, from pre-formulation studies to lab-scale development, scale-up, pilot-clinical manufacturing, technology transfer, and commercial production planning and execution.• Proficient in coordinating with cross-functional departments such as Analytical Development, Production, Regulatory, QA/QC, and Packaging to ensure smooth product development and technology transfers.• Proven ability to address critical product/project challenges, implement stringent control measures, resolve queries from regulatory bodies, adhere to GMP and pharmaceutical regulations, and develop SOPs and protocols to improve success rates.• Technical Documentations such as SOP CTD dossier parts, IMPD, Briefing Book, Technical Protocol-Reports, Technical presentations, manufacturing documents, specifications etc.• Development of drug device combination product of valve, actuator, dose counter, spacers, Nasal sprays and DPI devices for MDI & DPI product• Data interpretation : Statistical data interpretation using Design Expert, JMP, Minitab• Analytical data interpretation Pulmonary Products APSD by NGI, DUSA, Spray Pattern-Plume Geometry, Droplet/particle Size Analyzer Spraytech• Q3 Inhalation techniques such as MDRS, Dissolution, Realistic Breating Profile etc.
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