Ashish Tapadiya

About Ashish Tapadiya

Semisolids & Liquids Formulation Expertise: • 2 years of hands-on experience in pre-formulation / formulation / re-formulation of variety of dosage forms specializing in semisolids & liquids for branded and generic products (Rx Products) • Extensively worked on 19 Rx products in exhibit and commercial production, 8 clinical trial and many pre-clinical, early-phase developmental projects for dermal applications • Formulated a range of semisolid & liquid products (NDA & ANDA submissions) for topical use containing corticosteroids, anti-inflammatory, antibiotics, antifungal, anti-acne agents (Rx) & shampoos • Designed, manufactured & packaged (cGMP) clinical trial materials in suitable delivery systems (creams, ointments, gels, lotions, sprays etc) containing small molecules & biologics • Re-formulated generic equivalents of commercial products (ANDA submissions) with rigorous DOE utilization techniques, degradation kinetic data interpretation, stability studies & bio-equivalency comparison studies Process Development, Scale-up & Quality Systems Expertise: • Expertise in addressing cGMP scale-up (up to 2500 kg) & process development issues including critical process parameter (CPP) assessments, technology transfer to partner CMOs, validation, submission batches & other CMC related activities • Well versed in implementation of modern Quality Systems (QS) such as Corrective & Preventive Action (CAPA), Process Analytical tools (PAT), Quality by Design (QbD), Continuous Improvement, kepner Tregoe problem analysis. Background in pharmacy and basic chemistry, devised myself towards innovative drugs research and polymer characterization. Experienced in critical impurity analysis, formulation confirmation, lot selection for clinical trials.

Experience

1. Director, Scientific Affairs

   Aadhaar Life Sciences Pvt. Ltd.

   Aug 2016 — Present · Solapur, IN

   Develop and execute the company’s business strategies in order to attain the goals of the shareholders. Prepare and implement comprehensive business plans to facilitate achievement by planning cost-effective operations and market development activities. Delegate responsibilities and supervise the work of executives providing guidance and motivation to drive maximum performance. As Director for Scientific Affairs, responsibilities include and are not limited to; planning and conducting experiments, recording and analyzing data, carrying out fieldwork, ex. collecting samples, presenting results other research staff, writing research papers, reports, reviews and summaries, demonstrating procedures, preparing research proposals, supervising junior staff including technicians, organising product/materials testing, ensuring that quality standards are met, liaising with research staff, developing original solutions to problems, keeping up to date with relevant scientific and technical developments.

Education

• DSTS COllege of Pharmacy,

  Bachelor's degree, Pharmacy

  2007 — 2011

• INACTIVE-1703030558-LIU Brooklyn

  Master of Sicence, Chemistry

  2012 — 2014

Skills

• Formulation
• Nmr
• Waxd
• Gc-Ms
• Calorimetry
• Polymer Characterization
• Optical Microscopy
• Anti-Asthma Drug Synthesis
• Polymer Clay
• Drug Delivery
• Polymer Chemistry
• Glp
• Drug Development
• Dissolution Testing
• Gmp
• Organic Chemistry
• Uv/Vis
• Ftir
• Organic Synthesis
• Differential Scanning Calorimetry
• Infrared Spectroscopy
• Dissolution
• Uv-Vis Spectrometery
• Pharmaceutical Industry
• Ir Spectroscopy
• Hplc
• Manufacturing Scale-Up
• Ir
• Nuclear Magnetic Resonance (Nmr)
• Chemistry
• Disintegration