The Technical Project Manager provides day-to-day operational management for CMC development programs. Working in close partnership with the CMC Program Leader who drives program strategy, the project manager leverages their technical and project management expertise to serve as the operational hub for CMC program teams, driving execution, communication, and accountability across process development, analytical, formulation, quality, supply chain, and external partners.
This role blends technical understanding of biopharmaceutical CMC development disciplines with strong project management and coordination skills. Candidates are required to have biopharmaceutical industry experience through CMC technical roles with project management responsibility or through program management roles with deep understanding of CMC development.
Responsibilities
Project Operations & Execution
Lead day-to-day operational management of CMC development activities in an outsourced environment.
Apply technical judgment to build robust plans, anticipate risks, manage deviations, and respond to unforeseen challenges.
Build integrated CMC project plans, maintain, and track timelines, dependencies, and deliverables across CMC functions.
Ensure plans and timelines are executed as agreed.
Monitor progress against milestones, identify critical path activities, and proactively escalate issues.
Coordinate execution across internal technical teams and external partners (e.g., CDMO).
Risk & Issue Management
Support identification, tracking, and communication of CMC program risks (technical, regulatory, and supply-related).
Maintain risk registers, contingency plans, and decision logs.
Support the Program Leader in evaluating alternative scenarios and recommending operational adjustments.
Communication & Stakeholder Management
Manage day-to-day communication with internal stakeholders, leadership, and external partners.
Facilitate information flow between CMC teams and the Program Leader to ensure alignment and transparency.
Leverage technical background to help craft effective communications around complex CMC plans or issue resolution.
Prepare & maintain project dashboards, timelines, and progress reports for governance and program reviews.
Organize and facilitate CMC team meetings, including agendas, minutes, action tracking and documentation.
Budget & External Partner Management
Support contract-related activities, including statements of work, change orders, and purchase orders.
Track CMC and CDMO budgets, invoices, and spend in alignment with approved financial plans.
Coordinate with finance, legal, and procurement to support external sourcing activities.
Operational Excellence
Apply project management best practices to improve efficiency, consistency, and visibility of CMC execution.
Maintain and continuously improve planning tools, tracking systems, templates, and communication processes.
Partner with the CMC Program Leader and functional leads to strengthen CMC project planning and governance.