CMC Project Manager/Senior CMC Project Manager, Research & Development
Listed on 2026-10-02
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Management
Operations Management, Project & Program Management, Regulatory Compliance Specialist -
Business
Operations Management, Regulatory Compliance Specialist
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a CMC Project Manager/Senior CMC Project Manager, Research & Development based in United States.
This role leads cross-functional Chemistry, Manufacturing, and Controls (CMC) project management across the vaccine development lifecycle.
You will translate development strategy into integrated plans, schedules, budgets, milestones, and actionable deliverables.
The position coordinates internal teams and external partners, including contract manufacturers and testing laboratories.
You will drive accountability, manage dependencies and risks, and ensure work remains aligned with program objectives and commitments.
The role also contributes to governance, financial management, contract execution, and project controls.
Success requires strong collaboration, structured problem-solving, and the ability to manage complex, multi-year development programs.
This is a fully remote U.S.
-based opportunity with approximately 10–20% domestic and international travel.
- Lead day-to-day CMC project planning and execution, coordinating internal teams, service providers, contract manufacturers, laboratories, and other external partners.
- Translate CMC and program strategy into integrated schedules, budgets, resource requirements, deliverables, milestones, dependencies, and decision points.
- Develop and maintain logic-linked project schedules, identify critical paths and risks, and assess the impact of changes to scope, strategy, assumptions, timelines, costs, and resources.
- Establish clear project controls, including meeting agendas and minutes, action and decision logs, risk registers, milestone tracking, status reporting, and recovery plans.
- Monitor project performance against approved plans and work with accountable leads to address variances, delays, resource constraints, and other execution challenges.
- Facilitate cross-functional meetings and governance processes that promote alignment, resolve conflicts, accelerate decisions, and maintain progress.
- Provide clear project updates and recommendations to program leadership, governance bodies, funders, and other stakeholders.
- Manage service-provider relationships and hold partners accountable for contractual milestones, deliverables, schedules, budgets, reporting, and performance expectations.
- Partner with Finance, functional leaders, and Earned Value Management teams to monitor budgets, forecasts, actuals, resource requirements, and variances.
- Support prime contract and subcontractor planning and execution, including statements of work, requests for proposals, proposal evaluations, bases of estimate, and contract modifications.
- Develop and improve project-management tools, standards, processes, and practices that strengthen transparency, communication, accountability, and execution across R&D.
- Coordinate activities across working groups, technical teams, contract manufacturers, testing laboratories, consultants, and other stakeholders while ensuring decisions, risks, changes, and dependencies are communicated effectively.
- Bachelor's degree in a scientific, engineering, pharmaceutical, or related discipline; an advanced degree and/or PMP certification is preferred.
- 7+ years of relevant project management experience, particularly in Phase 2 and/or Phase 3 vaccine or biologic development.
- Demonstrated experience planning and leading complex, multi-year, integrated product-development programs involving multiple funding partners and service providers.
- Working knowledge of the CMC lifecycle from early development through validation, regulatory submission, and commercialization.
- Experience developing and managing integrated…
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