CMC Project Manager/Senior CMC Project Manager, Research & Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Guide cross-functional teams to strategize and execute Chemistry, Manufacturing, and Controls activities throughout the vaccine development lifecycle.

• Convert strategic goals into comprehensive plans that align with program objectives, contractual obligations, budgets, and milestones.

• Collaborate internally and externally with contract manufacturers, laboratories, service providers, and other stakeholders.

• Define deliverables, responsibilities, dependencies, and decision-making points; oversee performance and manage risks.

• Create and enhance project management tools and methodologies.

• Oversee daily planning and management of drug product process development service providers.

• Coordinate deliverables, timelines, dependencies, and inputs from various functions.

• Provide regular updates to Program leadership, governance bodies, funders, and stakeholders.

• Develop integrated CMC plans, timelines, budgets, resource needs, and deliverables.

• Create and manage linked schedules, critical paths, decision points, assumptions, and schedule-related risks.

• Assess plans, dependencies, and assumptions; evaluate the effects of scope, strategy, and assumption changes.

• Organize and conduct meetings to ensure alignment, resolve conflicts, expedite decisions, and maintain project momentum.

• Maintain project documentation, including controls, agendas, meeting minutes, schedules, action and decision logs, risk registers, and milestone reports.

• Track progress, identify discrepancies, and implement corrective or recovery measures.

• Coordinate activities among subteams, working groups, contract manufacturers, testing labs, consultants, and partners.

• Communicate decisions, risks, changes, and dependencies to relevant stakeholders.

• Model and uphold governance, decision-making, and escalation protocols.

• Manage budgets, forecasts, actual expenditures, and variance analysis with Finance, functional leaders, and Earned Value Management teams.

• Identify financial, resource, and capacity limitations and formulate corrective actions.

• Assist in planning and executing prime contracts and subcontracts.

• Facilitate statements of work, requests for proposals, proposal assessments, service provider plans, basis of estimate, and contract amendments.

• Oversee service providers to meet contractual milestones, deliverables, and budgetary expectations.

⛳️ Requirements

• Bachelor’s degree in a scientific, engineering, pharmaceutical, or a related field.

• Over 7 years of relevant experience in Phase 2 and/or Phase 3 vaccine/biologic project management.

• Proven skills and experience in planning and leading intricate, multi-year, integrated product development programs involving multiple funding partners and service providers.

• Familiarity with the CMC lifecycle from early development through validation, regulatory submission, and commercialization.

• Experience in supporting U.S. Government or other funding partners with contractually demanding planning, forecasting, and reporting requirements is highly preferred.

• Proficient in developing and managing integrated schedules, critical paths, dependencies, and recovery strategies.

• Experience in managing service providers, including CDMOs, CROs, and testing laboratories.

• Advanced proficiency in MS Project and Smartsheet.

• Familiarity with Microsoft 365 applications, including MS Teams and SharePoint.

• Knowledge of governance practices in the pharmaceutical industry.

• Experience with Earned Value Management and project control methods.

• Proven capability to hold teams and service providers accountable in a matrixed environment.

• Exceptional communication and interpersonal skills; ability to remain flexible and optimistic.

• Keen attention to detail; capable of managing complex tasks; highly organized, reliable, and able to prioritize competing demands to meet deadlines.

• Ability to process information swiftly, listen attentively to feedback, and adapt plans/actions as necessary.

• Willingness to travel approximately 10–20% domestically and internationally with prior notice.

• Subject to a criminal background check.

• Request for three professional references.

• Verification of education and degrees.

• Commitment to advancing Sabin's mission.

• Must be authorized to work in the United States without employer sponsorship.

• An advanced degree and/or PMP certification is preferred.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Flexible spending accounts.

• Flexible vacation leave.

• Sick leave.

• Short-term disability options.

• Long-term disability options.

• 10 federal holidays.

• End-of-year winter break.

• Employer matching 401(k) plan.