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

Sabin Vaccine Institute, Inc.

Northern (KY)

Hybrid

USD 108,000 - 164,000

Full time

6 days ago
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Benefits offered by this job

Healthcare benefits
Flexible vacation leave
401(k) plan

Job summary

Sabin seeks a CMC Project Manager/Senior Project Manager to lead cross-functional planning for vaccine development activities (Chemistry, Manufacturing, and Controls) across the development lifecycle.

The role partners with CMC and program leadership to translate strategy into integrated plans and ensures execution aligns with objectives, budgets, and milestones.

Qualifications

  • Bachelor’s degree in scientific, engineering, pharmaceutical, or related discipline; advanced degree and/or PMP certification preferred.
  • 7+ years in Phase 2/3 vaccine/biologic project management with complex, multi-year programs.
  • Strong knowledge of CMC lifecycle from development through regulatory submission and commercialization.
  • Experience with government or funding-partner planning, forecasting, and reporting is preferred.
  • Experience with integrated schedules, critical paths, dependencies, and recovery plans.

Responsibilities

  • Lead cross-functional planning to ensure delivery of CMC activities across the vaccine development lifecycle.
  • Coordinate internal and external partners, providers, and stakeholders with clear deliverables and dependencies.
  • Provide updates to program leadership and governance bodies; maintain schedules and budgets.
  • Develop integrated plans, schedules, budgets, and resource requirements; monitor critical path and risks.
  • Plan meetings to align teams, escalate issues, and ensure progress against the plan.
  • Manage budgets, forecasts, actuals, and variance analysis with finance partners.
  • Collaborate on statements of work, proposals, and contract modifications; manage subcontractors.

Skills

Communication
Attention to detail
Organized
Travel readiness

Education

Bachelor’s degree in scientific/engineering/pharma
Advanced degree and/or PMP certification

Tools

MS Project
Smartsheet
Microsoft 365 (Teams, SharePoint)

Job description

All Jobs > CMC Project Manager/Senior CMC Project Manager, Research & Development

CMC Project Manager/Senior CMC Project Manager, Research & Development
Fully Remote Remote Worker - US Only Research & Development

Full-time

Description

Reports to: Director, Technical Project Management, Research & Development (R&D)

Location: Remote Work (US Only)

Why Sabin:

Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.

Position Summary

The CMC Project Manager/Senior Project Manager leads cross-functionally to ensure planning and delivery of Chemistry, Manufacturing, and Controls activities across the vaccine development lifecycle. In partnership with CMC and Program leadership, this role translates strategy into integrated plans and ensures execution remains aligned with program objectives, contractual commitments, budgets, and milestones.

The CMC Project Manager coordinates internally as well as externally with service providers (e.g., Contract Manufacturers and Laboratories) and other partners. The role establishes clear deliverables, owners, dependencies, and decision points; monitors performance against plans; and holds teams and service providers accountable for timely execution, decision‑making, transparent information sharing, and risk management.

Responsibilities
Project Management
  • Develop and improve project management tools and practices that strengthen planning, transparency, communication, and execution.
  • Lead the day‑to‑day planning and management of drug product process development service providers and corresponding activities, coordinating deliverables, timelines, dependencies, and cross‑functional inputs to maintain alignment with CMC strategy and program milestones.
  • Provide clear updates to Program leadership, governance bodies, funders, and other stakeholders.
  • Contribute to the continued development of R&D project management standards and capabilities.
Strategy and Integrated Planning
  • Partner with Program and CMC leadership to translate development strategy into integrated CMC plans, schedules, budgets, resource requirements, and deliverables.
  • Develop and manage integrated and logic‑linked schedules that enable identification of critical path, decision points, assumptions, and schedule risks.
  • Critically evaluate plans, dependencies, and assumptions to ensure resulting schedules are realistic and aligned with program priorities and commitments.
  • Assess changes in scope, strategy, or assumptions and communicate the impact on schedules, cost, resources, risk, and downstream activities.
Execution and Accountability
  • Plan and execute meetings that promote alignment, resolve conflicts, accelerate decisions, and maintain progress against the plan.
  • Hold internal teams and service providers accountable for accurate status reporting, timely escalation, schedule integration, and delivery of work to schedule and budget.
  • Maintain effective project controls, including alignment driving agendas and meeting minutes, schedules, action and decision logs, risk registers, and milestone reporting.
  • Monitor and control progress against plans, identify variances, and partner with accountable leads to implement corrective or recovery actions.
  • Coordinate activities across sub team and working groups, contract manufacturers, testing laboratories, consultants, and other partners.
  • Ensure decisions, risks, changes, and dependencies are communicated to affected stakeholders.
  • Model and reinforce program governance, decision‑making, and escalation processes.
Financial, Contractual, and Resource Management
  • Partner with Finance, functional leaders, and Earned Value Management personnel to manage budgets, forecasts, actuals, and variance analysis.
  • Identify financial, resource, or capacity constraints and work with accountable leads to develop corrective actions.
  • Partner with technical staff and Grants & Contracts to support prime contract and subcontractor planning and execution.
  • Facilitate the development of statements of work, requests for proposals, proposal evaluations, service providers’ plans, basis of estimate, and contract modifications.
  • Manage service providers, ensuring delivery of contractual milestones, deliverables, and to budgets expectations.
Requirements
  • Bachelor’s degree in scientific, engineering, pharmaceutical, or related discipline; advanced degree and/or PMP certification preferred
  • 7+ years of relevant experience in Phase 2 and/or Phase 3 vaccine/biologic project management; demonstrated skills and experience in planning and leading complex, multi‑year, integrated product development programs with multiple funding partners and service providers
  • Working knowledge of the CMC lifecycle from early development through validation, regulatory submission, and commercialization
  • Experience supporting U.S. Government or other funding partners contractually rigorous planning, forecasting, and reporting expectations is strongly preferred
  • Experience developing and managing integrated schedules, critical paths, dependencies, and recovery plans
  • Experience managing service providers, including CDMOs, CROs, and testing laboratories
  • Advanced experience using MS Project and Smartsheet
  • Experience using Microsoft 365 applications, including MS Teams and SharePoint
  • Experience with Pharma industry governance practices
  • Experience with Earned Value Management and project controls
  • Demonstrated ability to hold teams and service providers accountable in a matrixed environment
  • Strong communication and interpersonal skills; ability to be flexible and optimistic
  • Strong attention to detail, ability to manage complex tasks, highly organized, dependable and able to prioritize competing demands to meet deadlines
  • Ability to process information quickly and listen carefully to feedback and comments from staff and adapt plans/actions accordingly
  • Ability to travel approximately 10-20% domestically and internationally with notice
Other:
  • Subject to a criminal background investigation
  • Request for three professional references
  • Verification of education/degrees
  • Commitment to furthering Sabin's mission

Sabin's philosophy is to ensure fair, unbiased, equitable, competitive compensation, and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $108,000 - $164,000. The exact compensation may vary based on skills, experience, training, and certifications/degree. As a grant‑funded organization, Sabin actively seeks funding for existing and new programs.

Sabin provides a comprehensive benefits package for eligible, featuring medical, dental, and vision coverage as well as flexible spending accounts. Eligible employees enjoy flexible vacation leave, sick leave, and both short‑term and long‑term disability options. The organization observes 10 federal holidays plus an end of the year winter break. Additionally, Sabin offers an employer matching 401(k) plan.

Work Authorization:

This position is not eligible for visa sponsorship. Candidates must be authorized to work in the United States without employer sponsorship.

Notice to Recruiters/Staffing Agencies

Recruitment vendors may not contact Sabin hiring managers, executives, or employees and must have an executed agreement on file. Unsolicited resumes do not create an agreement, and Sabin is not responsible for related fees.

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.

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