Leading and managing a scientific team for successful Technology transfer from Pilot/Exhibit Scale & Commercial scale for early phase to late phase of solid oral generic formulation for various regulated markets like USA, Europe and Mexico market.• Supporting in all regulatory queries related process part for various regulated agencies.• Handling Trackwise Change control management for all scale up, API variation, API site change, Regulatory query, CAPA related documents.• Review and approval of all manufacturing investigation related to Commercial batches.• Proving time to time training on subject matter for ensuring team bonding and knowledge sharing encouragement.

• Leading and managing a scientific team for successful Technology transfer from lab scale to pilot & production scale for early phase to late phase of solid oral generic formulation for various regulated markets like USA, Europe, Canada, Japan, Pepfar, Emerging markets etc.• Handling and coordinating all regulatory queries related process part for various regulated agencies.• Handling Trackwise Change control management for all scale up, API variation, Regulatory query, CAPA related documents.• Handling and coordinating with CFT’s for all manufacturing investigation related to scale up, Exhibit and Commercial batches for preparation, review and approval process. • Material Management, plan and arrange for all the material required for manufacturing of scale up, exhibit or investigational engineering batches. • Plan to prepare review and approval of all filling related documents for timely regulatory submission. • Proving time to time training on subject matter for ensuring team bonding and knowledge sharing encouragement.

• Leading and managing a scientific team for successful Technology transfer from lab scale to pilot & production scale for early phase to late phase of solid oral generic formulation for various regulated markets like USA, Europe, Canada, Japan, Pepfar, Emerging markets etc.• Handling and coordinating all regulatory queries related process part for various regulated agencies.• Handling Trackwise Change control management for all scale up, API variation, Regulatory query, CAPA related documents.• Handling and coordinating with CFT’s for all manufacturing investigation related to scale up, Exhibit and Commercial batches for preparation, review and approval process. • Material Management, plan and arrange for all the material required for manufacturing of scale up, exhibit or investigational engineering batches. • Plan to prepare review and approval of all filling related documents for timely regulatory submission. • Proving time to time training on subject matter for ensuring team bonding and knowledge sharing encouragement.

• Leading and managing a scientific team for successful Technology transfer from lab scale to pilot & production scale for early phase to late phase of solid oral generic formulation for various regulated markets like USA, Europe, Canada, Japan, Pepfar, Emerging markets etc.• Handling and coordinating all regulatory queries related process part for various regulated agencies.• Handling Trackwise Change control management for all scale up, API variation, Regulatory query, CAPA related documents.• Handling and coordinating with CFT’s for all manufacturing investigation related to scale up, Exhibit and Commercial batches for preparation, review and approval process. • Material Management, plan and arrange for all the material required for manufacturing of scale up, exhibit or investigational engineering batches. • Plan to prepare review and approval of all filling related documents for timely regulatory submission. • Proving time to time training on subject matter for ensuring team bonding and knowledge sharing encouragement.

• Leading and managing a scientific team for successful Technology transfer from lab scale to pilot & production scale for early phase to late phase of solid oral generic formulation for various regulated markets.• Supervising team as technical experts and provide major contribution for defining strategy, trouble shooting and training.• Plan to execute the Process Evaluation and Exhibit Batches for all the projects for regulatory markets based on Product Development Summary and Scale up experience.• Prepare and review of all related documents for regulatory submission for various markets. • Material Management for ensuring smooth and timely delivery of projects.• Co-ordinating with all CFT’s for all manufacturing related issues for ensuring smooth execution of product for meeting delivery timeline.

• Plane to execute the DoE trials, Process Evaluation & Exhibit Batches for all the projects for regulatorymarkets based on Quality by Design (QbD) concept utilizing FMEA principles.• Involved in preparing and reviewing of Product development report, Master formula record, Process optimization protocol, Cleaning validation protocol/report, Hold time study protocol/report, Exhibit batch report, Process Validation Protocol/Report etc. • Process development of Solid Oral Dosage form of various drugs for different regulated markets.• Involve in co-ordinating with CFT’s for smooth transition of transfer of technology from lab scale to pilot scale.

I started my career with Ind-Swift Ltd as an officer in Formulation Development department and wasassociated with this company for approx. 4.5 years. I worked on various drug delivery systems whichincludes immediate release as well as a few controlled release products of solid oral formulations. In addition to this I worked on Liquid orals delivery systems (i.e. Syrup, Suspension and Drops etc.), Semisolid formulation and a few sterile dosage forms. I have worked for Domestic (India) and Emerging markets formulations during this tenure. In this role I was involved for designing; scale up, technology transfer and trouble shooting for commercial batches of various products at different locations of the organization.