In my role as Radiopharmaceuticals project manager, I'm responsible for overseeing and executing full spectrum of project management activities of Radio Imaging products for US & Canada market. My key responsibilities includes collaborating with cross functional teams to develop comprehensive project plans to beat scope, time & cost baselines. Exploration & effective communications with Contract Manufacturing Organizations (CMOs) to overcome in house manufacturing slot availability constraints. Negotiating and managing agreements with CMOs. Identification & addressing operational challenges on day to day basis.

Offering project management consultancy services with a focus on establishing a Project Management Office (PMO) and implementing project tracking systems for client-oriented operations. Introduced Dashboards, Tracking tools, Baseline management, and Critical path evaluation mechanisms. Facilitating collaboration between R&D and Manufacturing operations with a specific emphasis on project efficiency.

Periodic customer interactions to establish strategic alliances and forecasting. Specialized in product life cycle management, cross-functional team management, and relationship management. Proven hands-on experience in cross-selling and fostering lifetime relationships with existing partners. Proficient in commercial budgeting and sales data evaluation to discern market trends. Possessing an in-depth understanding of regulatory guidelines for Human and Veterinary Pharmaceuticals in the North American region.

Contractual product development, contract manufacturing, Negotiations, Pricing & Contracts. In-depth involvement in the manufacturing of Active Pharmaceutical candidates for a comprehensive understanding of business intricacies. Expertise includes Sales Budgeting, Forecasting, Risk management, and client management.Possess a profound understanding of regulatory requirements, including USFDA, MHRA, and Health Canada. Accomplishments include executing the first four commercial launches with Felix Pharmaceuticals Inc. in the US market and leading the execution of over 15 projects within a portfolio of 35 over four years. Collaborated with functional group leads, overseeing in-house development, contract development, and third-party manufacturing. Led project strategies with portfolio and business development teams, managing cross-functional teams spanning formulation development, supply chain, finance, manufacturing, technology transfer, QC/QA, and portfolio management through regular cross-functional team meetings.

Successfully implemented a streamlined documentation review process and enhanced team engagement for US filings, ensuring the achievement of financial year goals. Maintained meticulous tracking of time, budget, and productivity across formulation development to ANDA filings, providing periodic updates through Management Information System (MIS). Conducted risk evaluations at project milestones and effectively managed multiple projects throughout their life cycle stages.Maintained close coordination with stakeholders including formulation development, supply chain, finance, manufacturing, QC/QA, and portfolio management. Conducted periodic meetings and reviews with internal and external customers to communicate project progress. Possesses a solid regulatory understanding of major regulated markets (US, EU, CA & Japan) as well as emerging markets.

Demonstrated proficiency and extensive hands-on experience in designing and executing multi-step synthesis, optimizing chemical processes, and scaling up synthetic methods. Accomplished the execution of over twenty projects within an eight-year span, encompassing full-time equivalent projects.Specialized in chemistry-biology interface client-driven programs, involving analog designing and synthetic route proposals. Skilled in conducting feasibility assessments for projects and contributing to the development of project proposals.