Responsibilities:
• Responsible for projects from research and development stage to health authority approval, in terms of strategic planning, timeline management, budget and cost management.
• To ensure effective integration of science and project objectives.
• To manage activities for specified projects at all development stages, interfacing with relevant functional groups, and with external suppliers, as necessary, to plan and coordinate the timely execution of CMC activities and contingencies.
• Leads and facilitates CMC Team meetings and is responsible for project logistics and documentation.
• To influence, develop, maintain, own and deploy all key project management tools. Ensure tools are used appropriately to enhance project delivery and information dissemination to the business.
• To ensure the production and maintenance of requisite project documentation to ensure delivery of the overall CMC Plan and milestones.
• To interface internally and externally as required in evaluation of clinical and nonclinical material demand and to provide appropriate planning, coordination and communication to enable supply of materials and information of the required quality standard.
• To represent CMC Team Management in cross functional initiatives of business impact, such as would benefit the design and establishment of organization processes.
• To collaborate with different representatives, harnessing creativity within cross-functional project teams to develop risk mitigation and contingency scenarios for projects.
• To anticipate operational issues at the project level, and, working within the cross project community, to influence solutions for similar issues in other projects.
Requirements:
• Master or Ph.D in Chemistry, Pharmaceutical or related degree
• Solid project management skill with excellent communication skills
• Fluent in written and oral English
• Experience in planning and managing the cross functional aspects of pharmaceutical product development.
• Experience in managing CMC teams responsible for development of pharmaceutical products is preferred.
• Experience in managing CMC project in various stage: starting from discovery stage, pre-formulation study, DRF batch, GLP Tox batch, GMP batch, IND filing, Phase I, Phase II, Phase III, and NDA filing
• Experienced in timeline preparation & management