Sabin Vaccine Institute

Director

• Quality CMC lead and support for all technical transfer and onboarding of new US-based drug product Fill/Finish site(s) for drug product.
• Quality CMC lead and support for all technical transfer and onboarding of new US-based drug substance manufacturing sites
• Provide Quality leadership in area(s) of expertise to potentially include cell line development, cell culture, purification, formulation development, analytical development and characterization, drug substance manufacturing and final drug product manufacturing
• Ongoing assessment and evaluation of GXP service providers to ensure regulatory compliance.
• Departmental lead for monitoring testing and inspection of materials and products by contract service providers to ensure identity, strength, purity and quality is maintained
• Participate in internal and external audits/ inspections including other quality assurance assigned activities
• Assist in development and implementation of quality system to identify, initiate and monitor corrective and preventive actions to support developmental and regulatory activities
• Quality CMC lead to manage, create and review CMC SOP’s and documentation as required
• Other duties as assigned

Director, Quality CMC

• Reports to Chief Financial Officer and leads design, oversight, evolution, and operation of Sabin’s program control systems
• Lead strategic development, implementation, and refinement of program controls and related FP&A systems
• Oversee integration of cost into master schedules and performance management across programs using EVM methodologies
• Integrate subcontractor, consultant, and other direct cost forecasts and actuals into overall program financial models
• Collaborate with cross-functional teams to validate subcontractor and consultant inputs and ensure accuracy in consolidated reporting
• Ensure financial integrity through forecasting, variance analysis, and long-range (annual and 5-year) budget planning
• Maintain accuracy in corporate financial reporting, cash flow tracking, and scenario modeling
• Ensure program controls infrastructure complies with FAR and other government and partner requirements
• Compile, interpret, and visualize program data; develop dashboards and performance metrics using Excel, Smartsheet, PowerBI, and Deltek
• Analyze program-level cost, schedule, and resource risk indicators and surface insights to guide corrective action
• Drive systems alignment and integration across scheduling, budgeting, and reporting systems; evaluate and implement technology/process improvements
• Lead internal and external audits related to project controls and contract performance and oversee development/submission of performance and financial reports to stakeholders
• Represent Sabin in steering committees, alliance management meetings, and governance bodies as necessary
• Manage, mentor, and develop program control staff and champion inclusive leadership and continuous improvement

Director, Program Controls

Project Manager

• Position Summary: As a CMC Project Manager within R&D, you will lead project teams and drive the initiation, planning, and execution of CMC activities across all phases of vaccine development.
• Lead and integrate cross-functional project teams, vendors, consultants, and external stakeholders ensuring deliverables are achieved and aligned with development program timelines and milestones.
• Manage project budgets, schedules, risk, and governance; partner with Finance and EVMS to monitor forecast vs actuals and support variance analysis.
• Facilitate tech transfer planning and lifecycle management; support post-approval CMC changes and lifecycle management.
• Partner with CMC functional leads to facilitate strategic planning, coordination, and integration across sub teams, vendors, and contractors; ensure alignment with program timelines and regulatory milestones.

Director, Quality CMC

Director, Program Controls

CMC Project Manager / Senior CMC Project Manager, R&D