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TITLE: Pharmaceutical Development and Manufacturing Project Management Associate
The Pharmaceutical Development and Manufacturing (PDM) Project Management contract position will assist with providing project management support to biologics CMC (chemistry, manufacturing and control) teams. Primary Responsibilities
-Development programs, and may include work on commercial programs and outsourcing teams.
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.
-Will work with the entire growing biologics organization to help deliver the portfolio.
-Essential duties include: completes assigned project management duties for multiple biologics CMC teams and projects under the guidance of senior project managers; 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; reports out on changes to project strategy and status in presentations to Sr. PDM leadership; ensures project work complies with established practices, policies, and processes
-Other duties may include contributing to PMO office and process improvement initiatives.
-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. Minimum of 5+years experience required. Required Degree or Certification: Bachelor’s degree required, PMP certification strongly preferred (not required)
