CMC Project Manager

CMC Project Manager responsibilities include, but are not limited to, the following:

• Independently plan, manage, and execute CMC project management in support of cGMP early-phase GMP biopharmaceutical product development.
• Lead project meetings including presenting dashboards and planning and tracking project timelines to drive to project completion. Facilitate discussions of progress, risks, timelines, and budgets.
• First point of contact to troubleshoot a wide variety of challenges encountered with project activities. Coordinate with external vendors on testing, reporting, and quality documents. Proactively communicate issues to key stakeholders to ensure a timely resolution and escalate as needed to ensure timelines are met.
• Collaborate to develop and plan testing required for investigations and responses to regulatory agency queries.
• Author protocols, reports, and filings. Coordinate with subject experts to review external analytical data and quality documents as needed.
• Proactively seek out senior collaborators to discuss potential solutions to problems. Ability to clearly present results of work, interpret data and draw conclusions. 
• Work collaboratively with cross functional departments to manage project activities.
• Maintain current knowledge of relevant cGMP regulation, regulatory guidance’s, and internal SOP requirements for method transfer activities.