VILAS SHOBHESING JADHAV

• · Setting up new R&D centre for Solid oral /liquid orals / Oncology/ Injectable dosage form.
• · Identified new products for regulated market.
• · Managing CMO/CRO and external lab for development work
• · Prepare the business case for overall R&D and portfolio management
• · Responsible for business development activities for Regulated markets.
• · Heading formulation/analytical/QA and Project management department.
• · Expanding new segment, new R&D centre for oncology and potent development
• · Successfully developed 18 products with successfully BE studies for regulated market
• · Looking Manage multiple projects through teams in own area of operation and ensure completion of projects within budgets and stipulated timeliness.
• · To develop pharmaceutical products equivalent to innovator products.
• · Provide inputs for analytical method development for product and review the data from the analytical tests and recommends shelf-life and packaging requirements.
• Accomplishments:
• ü 18 Successful Bioequivalence product developed.
• ü 2 molecules identified for 505 (b)(2) for different indications and filed the patent for proof of concept.Ü/li>
• ü Additionally handling business development responsibility and successfully signed licensing and supply deal around 4 million dollars in 2 years. On product approvals, expected business around 6-7 million dollars on every yearÜ
• ü New markets business established in USA, Greece, Germany, UK, Spain, Brazil, Chile, Peru, GCC countries under finished product license and supply model
• ü Successfully set up the new R&D Centre for general solid and liquid orals.
• Successfully set up new R&D Centre for Oncology and potent block for solid and liquid orals.

• Looking, manage multiple project thorough teams and in own area of operation and ensure timely completion of project

· To develop pharmaceutical products equivalent to innovator products.

· Provide inputs for analytical method development for product and review data from analytical tests and recommends shelf-life and packaging requirements.

· To prepare and review of Stability Protocols & Reports.

· To review documents like protocols and those relating to development, validation, manufacturing and packaging, like validation protocols, Master formula and their corresponding reports and to give suitable comments/ suggestions on same.

· To supervise manufacture of developed products and process validation of same.

· To review development trials logbooks, LNB’s etc.

· To prepare project proposals, project planning for all new projects.

· To prepare detailed project planning for all projects and to ensure that plan is adhered to. To ensure that all projects’ milestones are completed as per the agreed planning.

To track the progress of projects and report to the Director- R&D in case of any deviations.

• Controlled costs and optimized spending via restructuring of budgets for labor, capital assets, inventory purchasing and technology upgrades.
• Expanded cross-functional organizational capacity by collaborating across departments on priorities, functions and common goals.
• Applied customer feedback to develop process improvements and support long-term business needs.
• Maximized productivity by keeping detailed records of daily progress and identifying and rectifying areas for improvement.

• Mentored and guided employees to foster proper completion of assigned duties.
• Built strong relationships with customers through positive attitude and attentive response.
• Maximized efficiency by removing safety hazards and debris from work areas.
• Molded team and embraced change to adapt within dynamic market.

• Responsible for production and technology transfer activities for tablets and capsules dosage form..
• Collaborated with colleagues, technicians and leading pharmacists in effective prioritization and filling of orders.
• Managed overall day in day out activities for production.

• Pre-formulation Studies.
• Development of new formulations.
• Pilot plant scale-up.
• Excipient’s compatibility study
• Transfer of technology to manufacturing units.
• Trouble shooting at production floor.
• Documentation pertaining to developmental activities.
• Development report preparations.