Samir Das

Background

About Samir Das

TECHNICAL SKILLS:#Competency-A competent professional with deep scientific excellence in formulation R&D, process development, Regulatory and Intellectual property for global markets.#Innovative & result-driven leader- Proven track record of successful delivery from product selection to commercialization with Sound scientific principles of QbD, DoE, statistics, and technology transfer. Proven track record of developing time-bound products; filed more than 20 ANDAs; 5 FTF products in the US market in a row.#Introspection/problem solver- Exercise sound reasoning to analyze formulation development, process issues, provide technical guidance, make decisions, and overcome problems.#End-to-end product development- The interface on all project activities like licensing, pre-formulation studies, formulation development, stability studies, BE study, manufacturing process, tech transfer, validation, build-up of regulatory dossier for submission, addressing regulatory queries, and support for commercial launch.#Novelty- Core competence in formulation design for global markets with IP protection; active participation in filling of 5 patents worldwide. TEAMWORK:#Co-ordination with internal and external stakeholders to ensure that the deliverables & milestones are met with respect to product development, filing, approval and timely launch of the products.#Co-ordination with global sites and global partners for execution of work and delivery of assigned development projects within the timelines.#Co-ordination with stakeholders/cross functional teams Analytical R&D, Project management, MS & T- teams, Global manufacturing operations, Quality assurance, and Quality control teams, and global regulatory departments. PEOPLE & TEAM MANAGEMENT:#Motivate, develop, and train subordinates with requisite skills to reach the targeted level of performance.#Support project delivery through effective alignment of teams, infrastructure, and projects as per business requirements.#Strong team building skills to drive complex projects; mentoring team members on technical as well as other aspects for goal orientation and driving high performance. GLOBAL/CROSS-CULTURAL FLUENCY:#Value, respect, and learn from diverse cultures, races, genders, and religions. Demonstrate openness, inclusiveness, sensitivity, and the ability to interact with all people and understand individual's differences.