Heading Injectable and ophthalmic product development team within vertical of Third Party Operations.Defining workflows, creating and maintaining project management processes, templates.Resource allocation of projects based on technical criticality, market potential and launch opportunities.Define project strategies get necessary management endorsements Enables open box thinking and alignment to organizational goals.Providing leadership support to the team members coming up with their plans, ideas and solutions.Encouraging a culture of participative, proactive, and accountable work culture within team.Complementing shortfalls of individual team member with task level involvement when need arises.Providing regular updates to management and seek necessary endorsements and approvals on project strategies, budgets, timelines.

Leading a team of strong product development professionals focused on delivering injection, ophthalmic development projects working with domestic and international partner companies.Defining project scopes, development strategies, budgets, and timelines. Managing budget and timeline balances and deviations. Evaluating team and partner companies for allocation of projects. Identifying, and mitigating project risks.Project planning and execution in co-ordination with internal teams and partner companies. Handling scope and budget creepsResolution of hurdles, bottlenecks, gaps and technical challenges with help of cross-functional team.

Managing diverse product development portfolio from development stage to submission, approval and initial commercial launch of Solid orals, injections, ophthalmics in Canada market.Evaluation of prospective partners companies who can develop and manufacture drug products.Identification of API and equipment suppliers as per project needs.Preparation of scope of work, evaluation of suitable partners, negotiating development/execution fees and transfer prices.Project planning, costing, logistic management for smooth delivery of productsEffective co-ordination with partner companies for on time execution of ongoing projects.Negotiating service fee and transfer prices.

Leading a team of formulation development professionalsDevelopment and tech-transfer of solid oral and liquid oral drug productsPreparing Scope of Work, man hour budget, timeline planning for new projects.Regular communication and interaction with customers for update and strategy of ongoing projects.

Formulation Development of solid orals for Brazil, Japan and US. including First to File products in portfolio.Designing non-infringing formulation strategies for generic solid orals, including IR, DR, SR tablets and IR and DR capsules. Development activities performed based on QbD principle.Co-ordination with cross-functional teams for execution of projects in timely manner.Interpretation of analytical and BE data to ensure development of robust formulation strategy.Making technical presentations to senior management about progress of the development.Preparation of Product Development Report, Tech Transfer report, Investigation reports, query responsesPlanning of RMs, documents, logistics and man-power support for execution of scale up and exhibit batches.

Formulation Development of Generic products for US/EU/Brazil regions based on QbD principle.Exposure in development of IR, DR, MR tablets (matrix and monolithic), IR capsules, pellets.Literature evaluation, execution of formulation development trials, scale up and registration batches, trouble shooting. Well experienced with all manufacturing equipment for oral solid dosage forms.Preparing Product Development Reports and other technical documents for product.Interpretation of analytical and BE data.Preparing review presentation for discussion with senior management at various development stagesResponding regulatory queries.

Supporting FnD scientists in execution of trial batches.Hands on experience on granulation, tableting, coating, encapsulation and packing processes.Hands on experience on dissolution apparatus and UV spectrophotometer.Preparing project progress report and dissertation.