Biologics CMC Project Manager

The Pharmaceutical Development and Manufacturing (PDM) Project Management contract position will assist with providing project management support to biologics CMC teams.


Responsibilities :
• Collaborates with the team to ensure continuity of supply for clinical studies and commercial markets.
• Organizes team to execute on the planned activities, manages deviations from the plan, and mitigates risks; works with CMC lead to set focused agendas, facilitate meetings, document minutes, and track actions.
• Develops and manages detailed project timelines for CMC activities.
• Include development programs, and may include work on commercial programs and outsourcing teams
• The Project Management contractor will collaborate with the following groups: 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.
• The Project Management contractor will assist with management of multiple projects concurrently and may be responsible for maintaining and tracking various project activities, timelines, meeting minutes, action items, resource plans, and other project documents as requested.

Qualification :
• BA/BS OR MA/MS/MBA
• 3-5 years relevant experience
• Has complete knowledge of full cycle project management, from project start-up to close-out.
• Has advanced knowledge of project management best practices and tools and has shown ability to apply these to improve project efficiencies and effectiveness