Pharmaceutical Development And Manufacturing Project ManagementThe Pharmaceutical Development and Manufacturing (PDM) Project Management contract position will assist with providing project management support to biologics CMC teams.
Responsibilities include:Collaborating with the team to ensure continuity of supply for clinical studies and commercial markets.Organizing the team to execute on the planned activities, managing deviations from the plan, and mitigating risks; working with CMC lead to set focused agendas, facilitate meetings, document minutes, and track actions.Developing and managing detailed project timelines for CMC activities, including development programs and possibly work on commercial programs and outsourcing teams.Collaborating with Bulk Drug Substance, Drug Product, Analytical Operations, Quality Control, Quality Assurance, Packaging & Labeling, Global Supply Chain, Clinical Supplies Management, Outsourcing, Regulatory Affairs, Commercial Manufacturing, and the Corporate Project Team.Assisting with management of multiple projects concurrently and maintaining and tracking various project activities, timelines, meeting minutes, action items, resource plans, and other project documents as requested.Qualifications:BA/BS OR MA/MS/MBA3-5 years relevant experienceComplete knowledge of full cycle project management, from project start-up to close-out.