Mahendra Gadakh

Innovative, accomplished, results oriented pharmaceutical professional with 12+ years of progressive experience across a broad range of product development functions in the pharmaceutical industry. Proven ability, to develop the drug products with strong technical background in pre-formulation, formulation development, process development / optimization and technology transfer. Good team handling skill with result oriented time management to meet the timelines. Seeking for challenging carrier in an innovative research organization, that will utilize my skills and expertise in the field of formulations for mutual benefit of me and organizational development. Organized Team Leader builds positive rapport, inspire trust and guide teams toward achievement of organizational goals. Strong facilitator adept at working cross-departmentally with co-management and top-level leadership. Excellent trainer and mentor. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

• Literature search for product and patent information
• Indentify and assign CPP and CQA of drug product to be developed.
• Indentify and assign CMA of excipient to be used in drug product development.
• Designing pre-formulation / Drug - excipient compatibility study
• Innovator sample evaluation and stock maintenance
• Monitor experiments towards developing formulations in the areas of oral dosage forms i.e. tablets (IR tablets, ER tablets, DR Tablets), capsules (soft gel), liquid orals (solution, suspension)
• Development of generic equivalents of solid and liquid oral dosage forms for USA and EUROPE market
• Conduct and evaluate the stability programs a per ICH guidelines supporting the product development process.
• Formulation development of solid dosage forms for regulated and semi-regulated market.
• Improvements in existing formulations, cost reduction etc. (source change, CIP)
• Preparation of technical documents like Product Development Report, Master Manufacturing Formula, Product Specifications, stability Protocols, query response etc.
• Review of technical documents like Raw Material Specifications, Master Packaging Card, stability data, site transfer batch plan, sampling plan, validation protocol etc.
• Technology transfer of the developed products
• Co-coordinating between various departments like RA, ADL, IPR, PDL, Packing, Purchase, Production for efficient timely execution of the projects.
• To support CFT for other market extension (like Canada, South Africa) activity of filed products.
• To guide and train subordinate to improve team work and enhance productivity.

• Para IV (FTF)
• Successfully developed & technology transferred of Immediate Release Tablets (Antihypertensive, Antipsychotic & Antidepressant) for USA Market.
• Para III
• Successfully developed & technology transferred of Immediate release tablets containing anti diabetic agent for Europe Market.
• Successfully developed & technology transferred of Extended release tablet containing anti diabetic agent & electrolyte supplement for USA Market.
• Cost saving project/ Troubleshooting project:
• Successfully stabilized formulation with alternative source of API
• Projects for Domestic market:
• Successfully developed two to three - two active anti biotic, one active anti cancer immediate release tablet dosage forms for Indian Market.
• Successfully technology transferred of one topical dosage forms (gel) for Indian Market.

• Father's Name: Kacheshwar Vishnu Gadakh
• Gender: Male
• Marital Status: Married

• Expert in using the Internet search using various scientific databases like USPTO, Scifinder, Espacenet, Elsevier, Pubmed, etc.
• Familiar with MS office (MS word, MS Excel, MS Power point).