CMC Project Management Manager
Summary of Key Responsibilities:
· Management of project plans and timelines for the completion of all ongoing CMC activities (Chemistry, Manufacturing, and Controls) required to support Life Cycle Management of Commercial programs
· Work together with Commercial CMC leads and expertise areas (Regulatory Affairs, Manufacturing, Manufacturing Operations Support, Process Sciences, Supply Chain and Quality) to establish/update project plans including risk mitigations for the Technical Operations and Quality Organization
· Support Early-Stage programs by updating ES/Development CMC templates in Smart Sheet to stay current with the changes in the process
· Collaborate with CMC PMs and leads on improvement of project plans including resources and risk mitigations for the Technical Operations
· Prepare and present project improvements to CMC PM team
· Bachelor’s degree is required. Degree in life sciences/engineering is strongly preferred
· 3-5 years of development and/or project management experience within the biopharmaceutical or pharmaceutical industry
· Experience with different stages of CMC development (Early stage (Ph I/II clinical trials) and Late/Commercial) preferred
· Experience working with MS Office Suite (Excel, Word, PowerPoint) and Smart Sheet
· Highly motivated and flexible, with excellent organizational, time and project management skills
· Strong interpersonal and communication skills
· Ability to work independently and as part of a multi-disciplinary team
Pay ranges between $55-63/hr based on experience
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