ATISH GURSALE

Industrious and enthusiastic Analytical method development offering 10 years of pharmaceutical experience. Proven to consistently meet productivity, business and customer service objectives. Skillfully work with all employees to enhance performance and improve day-to-day processes. Efficient in resolving internal and customer issues to maximize satisfaction.

• Quantitative determination of eugenol from Cinnamomum tamala Nees and Eberm.
• Leaf powderand polyherbal formulation using reverse phase liquid chromatography” Chromatographia, 2005.
• Quantitative determination of eugenol from Cinnamomum zeylanicum leaf powder by usingHPTLC” Indian Drugs, 2006.
• Simultaneous quantitatvie determination of Methyl Eugenol & Cinnamaldehyde from bark ofCinnamomum zeylanicum Blume using high performance liquid chromatography” 43rdAnnualConvention of Chemists.
• Dr.
• Babasaheb Ambedkar Marathwada University, Aurangabad, 2006.
• Standardization of Cinnamomum species using analytical techniques”, presented a poster in the NationalConference on “Plants in Relation to Man & Biosphere” at St.
• Xavier’s College, Mumbai, 20072 of 2.

• Organisational skills – Managing Analytical R&D team for projects in development of drug substance and drug products
• Method Development – Assay and Impurity method development for solid, semi-solid and liquid oral dosage forms.
• Method Validation – Preparation of Method Validation protocols. Method Validation of impurities.
• Stability Study – Stability study of drug products.
• Documentation skills – Preparation of Raw Material, Finished Products, In-process, Stability specifications. Preparation of Standard Operating Procedures for instruments and equipments.Efficient and productive in hiring executive talent Skills
• Leadership Method Transfer
• Team building and Training Motivating the team successfully
• Instrumentations Incidents/Deviations Pt. Natura Laboratoria Surabaya, Indonesia Manager – Analytical Development April 2018 to present
• Managing new product development, conducting analysis such as raw materials, IPC, drug products using HPLC, UV, Dissolution, FTIR according to compendial in a GMP enviornment.
• Developing and validating methods to test pharmaceutical raw materials and finished products for strength, identity, impurities, and dissolution performance as per the FDA requirements.
• Designing analytical studies and writing protocols to support formulation and pharmaceutical process development and manufacturing activities.
• Interacting with external sources like a supplier of instruments, reagents, research institutes, external laboratory and internal source like QC, QA and purchasing teams. Roha Dyechem Pvt Ltd Mumbai, India Group Leader – Analytical Development November 2014 to February 2018
• Management of analytical laboratory operation and quality system, contracting, outsourcing, global networking, and analytical method development support
• Analytical method development of synthetic food colors/pigments/food dyes .
• Reviewing data for technical quality and compliance to protocols, methods, and SOP’s.
• Responsible for maintaining the chemical inventory, ordering lab supplies involved in preparation, delivering expenditures and consumables budget plans. Inventia Healthcare Pvt Ltd Mumbai, India Senior Scientist – Analytical Development January 2009 to November 2014
• Developed and executed chemical and instrumental methods (HPLC, GC, UV, FTIR) of analysis for development compounds, drug substances, raw materials, intermediates, drug products, cleaning verification as per pharmacopeia
• Evaluation of transdermal products.
• Developed methods for the determination of bile acid salts binding capacity from finished dosage formulation products.
• Prepared method development reports, SOP’s and required protocols for ANDA’s, Specifications and quality system related documents.
• Performed analysis on raw materials, drug products, and stability products using a variety of instrumental and wet chemistry techniques Therapeutic Drug Monitoring Laboratory Mumbai, India Assistant Quality Manager – Bioequivalence Clinical Trials March 2004 to December 2008
• Preparing reviewing analytical data, technical reports, and analytical methods in support of and for inclusion in the regulatory submissions.
• Performed validation, qualification of analytical methods as per ICH guidelines.
• Worked on LCMS/MS (API 2000 Triple Quadrupole) for identification, quantitation of small molecules
• Actively involved in Psoriasis, Vitiligo clinical trials on humans.
• Performed analytical testing of plasma samples, stability samples for Bioequivalence clinical trial studies.
• Performed wet chemistry assays, HPLC, GC, UV-VIS.

Publications and Presentations
• “Quantitative determination of eugenol from Cinnamomum tamala Nees and Eberm. Leaf powder and polyherbal formulation using reverse phase liquid chromatography” Chromatographia, 2005
• Quantitative determination of eugenol from Cinnamomum zeylanicum leaf powder by using HPTLC” Indian Drugs, 2006
• “Simultaneous quantitatvie determination of Methyl Eugenol & Cinnamaldehyde from bark of Cinnamomum zeylanicum Blume using high performance liquid chromatography” 43rd AnnualConvention of Chemists. Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, 2006
• “Standardization of Cinnamomum species using analytical techniques”, presented a poster in the National Conference on “Plants in Relation to Man & Biosphere” at St. Xavier’s College, Mumbai, 2007