Advise on technical matters related to product development and general R&D operations.

Project Leadership and Project Management Manage project(s) budget of approx. $1.5 Million every year and ensure it is utilized as planned. Creating and maintaining project deliverables such as project charters, plans & schedules, status reports, communication plans, issues, risk mitigation, minutes and milestone/deliverable charts. Managed end to end projects right from licensing, development, technology transfer, registration batches, clinical study, filing, deficiency till launch period, process validations (30 batches). Propose integrated product development plans, exploratory requests, development & production requests. Work cross-functionally to manage trade-offs, align stakeholders and maximize business value.Product Development and Technology Transfer Oversee and mange product developments to ensure products on shelf (sustainment) and support innovation pipeline. Handled and lead functions like product development, process development, planning and execution of scale up and Exhibit batches, documentation to support Drug regulatory affairs, Validation of first three commercial batches. Align with Capacity planning for logistics. Improve connect between Plant and R&D. Represent R&D and Technical transfer in regulatory (USFDA, MHRA, ANVISA) and Customer Audit and ensure approval with right first-time approach.Team Management Leading, mentoring & monitoring the performance of team members - Team comprises of high performing formulation & analytical scientists, process engineers and project managers. Recruit, train and retain talent for my team as well as critical SME roles. Mentor and coach scientists, engineers and project managers for career development and technical rigor.

• Leading a team of high performing formulation and analytical scientists.• Lead and ensure all projects are on track and meet milestone delivery. • Recruit, train and retain talent for my team as well as critical SME roles. • Propose integrated product development plans, exploratory requests, development & production requests.• Approve documents for execution of Pilot and Exhibit batches.• Mentor and coach formulation and analytical scientists for career development and technical rigor.• Ensure mid-year and annual performance reviews of team are completed in time.

• Led a group of about 8 formulation scientists in collaboration of 10 analytical scientists. • Developed high performing team and managed resources efficiently in a CRO set up. • Spotted and developed 2 formulation team leads. Supervised 4 M Pharm students for industrial training and thesis work. • Developed and mastered client management skills by interacting with diverse customers for efficient product development.• Managed project budgets and milestone delivery to ensure business continuity with existing clients and bring new clients.• Led and supervised multiple product developments - Generics, Speciality Products, NDDS Formulations, Amorphous Pharmaceuticals. • Strategized the non-infringing / alternate (para IV) formulations for US, EU and other regulated markets.• Approved documents for execution of Pilot and Exhibit batches.

• Led a team of 5 formulation scientists. Supervised & trained 3 M Pharm interns.• Led and supervised > 10 challenging formulations in formats of Sustained Release, Delayed Release, multi-dose to once a day conversion, First to File and para IV ANDAs. Strategized non-infringing formulations for US and European markets.• Learned and implemented Solid-State Pharmaceutics (Amorphous system) and launched stable product.• Reviewed and authored few Patent Applications out of our scientific-technical work.• Reviewed and approved documents for execution of Pilot and Exhibit batches – Study protocols & reports, MFC, MPC, BMR, BPR, PDR, Specifications, R&D SOPs etc.• Developed influencing skills in interaction b/w plant and R&D for execution of Pilot & Exhibit batches.

• Learned pharmaceutical product development specifically in oral solid dosage forms – tablets, capsules, powders, pellets etc. Mastered literature and patent searches and applied in product development.• Learned salt-screening to screen the best salt form and subsequent formulation development. Screened 3-5 salts each of about 8 active ingredients.• Executed preformulation, lab-scale and Pilot-scale experiments and batches. Developed 3 immediate release and 2 modified release formulations. • Reviewed & compiled development and stability data to help decision making.• Got exposure in the development of hormonal products - including handling containment & precautions.• Authored and reviewed documents for execution of Pilot and Exhibit batches – Study protocols & reports, BMR, BPR, PDR, Specifications, R&D SOPs etc.