About the company
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.
Responsibilities
- 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.
Requirements
- 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 schedules, critical paths, dependencies, milestones, and recovery plans.
- Experience managing external service providers, including CDMOs, CROs, testing laboratories, and other technical partners.
- Experience with contractually rigorous planning, forecasting, reporting, and stakeholder management; U.S. Government or other funding-partner experience is strongly preferred.
- Advanced proficiency with MS Project and Smartsheet, along with experience using Microsoft 365 tools such as Teams and SharePoint.
- Experience with pharmaceutical industry governance practices, Earned Value Management, and project controls.
- Strong ability to operate in a matrixed environment, establish accountability, and influence internal teams and external providers without relying solely on direct authority.
- Excellent communication and interpersonal skills, with the ability to provide concise updates, facilitate collaboration, and adapt to changing priorities.
- Highly organized and detail-oriented, with the ability to manage complex tasks, competing demands, deadlines, and multiple workstreams.
- Strong analytical and problem-solving abilities, with the capacity to process information quickly, listen to feedback, and adjust plans or actions accordingly.
- Ability and willingness to travel approximately 10–20% domestically and internationally with advance notice.
- Must be authorized to work in the United States without employer-sponsored visa support.
- Employment is subject to a criminal background investigation, education/degree verification, and provision of three professional references.
Conditions
- Annual salary range of $108,000–$164,000, with actual compensation based on skills, experience, training, certifications, and education.
- Fully remote work within the United States.
- Medical, dental, and vision insurance.
- Flexible spending accounts.
- Flexible vacation leave and sick leave.
- Short-term and long-term disability coverage.
- 10 federal holidays plus an end-of-year winter break.
- Employer-matching 401(k) retirement plan.
- Opportunity to contribute to vaccine development and broad