Project Manager, CMC
Core
Strategic and operational partner to CMC leadership, managing development programs from clinical development through regulatory submission and launch readiness.
Role type
Senior IC Project Manager (CMC)
Builds
Integrated project plans and governance processes for pharmaceutical development programs
Domain
Pharmaceutical industry, Chemistry, Manufacturing, and Controls (CMC)
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
CMC development expertise, cross-functional coordination, timeline management, risk and issue management, resource coordination, budget tracking, vendor coordination, Smartsheet proficiency
Preferred skills
NDA Module 3 preparation experience, CDMO management experience, PMP certification, familiarity with procurement/financial systems (Coupa, Ivalua, SAP, Ariba)
Technologies
Smartsheet, Coupa, Ivalua, SAP, Ariba
Responsibilities
Implement CMC governance processes and RAID frameworks, develop and maintain detailed CMC project plans, coordinate execution across CMC workstreams, monitor execution and identify risks, facilitate mitigation plans, develop governance reporting materials, support functional-area budget management, oversee CDMOs and suppliers, drive adoption of standardized project management tools
Seniority
Senior, hands-on IC
