Sabin Vaccine Institute

Associate

• Provide day-to-day coordination across all project workstreams
• Support the Project Manager in overall project execution
• Prepare materials for internal and external meetings
• Track progress against milestones and support donor reporting
• Coordinate with consultants, vendors, and internal teams
• Support engagement with global, regional, and country-level stakeholders
• Coordinate implementation of communities of practice (CoPs)
• Support the development, organization, and dissemination of knowledge products
• Assist with formatting, editing, and quality control of project deliverables

Senior Associate, Vaccine Demand – Implementation

Project Manager

• Support Program and Project Managers in coordinating day-to-day activities and tracking progress of vaccine development programs.
• Partner with Sabin staff to plan and monitor activities, timelines, forecast and actuals, and deliverables to ensure successful completion within established timelines.
• Coordinate across teams and programs to ensure seamless communication and alignment.
• Coordinate the preparation, tracking, review, polishing, and filing of deliverables to ensure timely submission to stakeholders (inclusive but not limited to weekly dashboards, biweekly and monthly reporting).
• Support meeting execution, including scheduling, preparing meeting agendas, taking minutes, tracking and monitoring action items, and circulating materials to attendees.
• Assist in creating, maintaining, and updating project timelines using Office Timeline, Smartsheet and MS Project in coordination with Program and Project Manager(s) and Scheduler.
• Maintain up to date project files and ensure document control within project management systems.
• Assist in developing and improving Program and Project Management processes and tools to support execution and overall R&D operations.
• Support improvement projects by providing planning and execution leadership.

Project Coordinator, Research & Development

Director

• Lead the strategic evolution of Sabin’s QMS to support late-stage clinical development, licensure readiness, and future commercialization
• Oversee and continuously improve eQMS, including document control, training, deviations, Corrective and Preventative Actions (CAPA), change control, risk management, management review, and supplier quality processes
• Develop and maintain quality governance processes, quality metrics, and management review programs that drive compliance, transparency, and continual improvement
• Lead implementation of Quality risk management principles consistent with ICH Q9
• Establish and maintain enterprise inspection readiness programs supporting sponsor audits, regulatory inspections, Bioresearch Monitoring (BIMO) inspections, and Pre-Approval Inspections (PAI)
• Provide strategic oversight of supplier quality programs, including qualification, auditing, monitoring, and governance of Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), laboratories, and critical suppliers
• Lead data integrity initiatives and ensure adherence to ALCOA+ principles across GxP systems and processes
• Oversee investigations, deviations, change controls, CAPAs, and effectiveness verification activities
• Partner cross-functionally with Technical Operations, Clinical Development, Regulatory Affairs, Supply Chain, and external partners to ensure phase-appropriate compliance
• Support health authority interactions, inspection responses, and remediation activities, ensuring sustainable corrective and preventive actions
• Promote a culture of quality, accountability, continuous learning, and operational excellence across the organization
• Carry out other responsibilities as needed to support organizational priorities and public health goals.

Director, Quality Systems – Research & Development

General

• Support the analytical development and testing activities necessary to advance vaccine candidates through the development pipeline.
• Report to the Senior Manager, CMC Analytical Sciences.
• Collect, monitor, and interpret analytical testing data from external laboratories.
• Provide technical direction and guidance to CDMOs and external labs.
• Collaborate internally to progress assets swiftly through development and into commercialization.
• Provide guidance and troubleshoot analytical method issues.
• Support tech transfer activities between external labs/CDMOs.
• Provide review and authoring support for analytical and stability sections of regulatory submissions.
• Participate in the development of internal systems and standards related to late-phase analytical development.

Scientist, CMC Analytical Sciences

Administration

• Support the drafting, review, and editing of contract-related documentation for U.S. Government (USG) prime contracts, including requests for subcontracting approvals and modifications to prime awards.
• Coordinate with Program Management, Subject Matter Experts, and Finance teams to gather required details and documentation to support timely submission of requests to funding agencies.
• Assist with ensuring compliance with applicable regulations and prime contract terms and conditions.
• Contribute to the preparation and negotiation of subawards, subcontracts, and consultant agreements, ensuring alignment with prime award requirements.
• Track and monitor the status of contract actions, including approvals and modifications, helping to ensure deadlines are met.
• Maintain organized contract files and documentation to ensure audit readiness and internal tracking.
• Provide general administrative and operational support to the GCM team as assigned.

Contract Administration Specialist

• The Director/Senior Director, CMC Validation reports to the Vice President, Chemistry, Manufacturing, & Controls (CMC) and is a strategic, hands-on leader responsible for building and implementing a comprehensive validation program for Sabin’s vaccines.
• This individual will build Sabin’s validation strategy from the ground up and implement it across the network.
• Responsibilities include authoring validation policies, procedures, templates, and related documentation; overseeing validation activities at C(D)MOs; and driving the organization to Process Performance Qualification (PPQ) readiness in alignment with FDA, EMA, WHO, and ICH expectations.
• The role is accountable for designing, hiring, and leading a right-sized validation organization.
• This position will partner closely across CMC, with Program & Portfolio Management, Quality Assurance, C(D)MOs, and other stakeholders to ensure validation requirements are fulfilled in a smart, risk-based manner, ultimately delivering submission-ready data packages.
• The Director/Senior Director, CMC Validation serves as a validation subject matter expert (SME) with demonstrated experience building and implementing validation programs for late-phase assets.
• This role will also support future funding initiatives and enable technology transfers to alternate manufacturers.

Director/Senior Director, CMC Validation

Manager

• Direct analytical activities conducted by external laboratories and contract development and manufacturing organizations (CDMOs)
• Provide expert technical leadership in CMC analytical sciences including development, qualification, validation, and transfer of analytical methods
• Collaborate cross-functionally to ensure analytical strategies meet regulatory expectations
• Lead and oversee ICH-compliant stability programs including forced degradation studies
• Compile, review, and analyze analytical data in support of development programs

Senior Manager, CMC Analytical Sciences

Recruitment

• Lead the full-cycle recruitment process for R&D teams across various scientific groups, including CMC, nonclinical, clinical, regulatory, quality and project management
• Collaborate with hiring managers and department leaders to understand team needs and create tailored recruitment strategies to meet those needs
• Source, attract, and evaluate candidates through a combination of methods, including job boards, LinkedIn, professional networks, and direct outreach
• Conduct initial pre-screenings, in-depth interviews, and assessments to ensure candidates meet technical requirements and organizational cultural
• Partner with Senior Director, HR and the hiring manager to refine job descriptions, interview processes, and candidate pipelines
• Maintain and manage recruitment activities in the applicant tracking system (e.g., Paylocity), ensuring up-to-date and accurate tracking of candidate progress and hiring status
• Build and maintain a strong talent pipeline for current and future openings
• Stay current on industry trends and talent pools within the vaccine, biotech, and pharmaceutical sectors
• Represent the company at job fairs, networking events, and conferences to promote the employer brand and attract top talent
• Provide a positive candidate experience through effective communication and feedback throughout the hiring process
• May assist with the recruitment process of non-R&D positions that support R&D (such as finance, grants & contracts), if needed
• Provide backup coverage for new hire orientation, ensuring a smooth and welcoming onboarding experience when primary coverage is unavailable
• Coordinate with HR team members, hiring managers, and internal stakeholders to support onboarding logistics and timely completion of pre-employment and orientation activities
• Support broader talent acquisition initiatives and programs, such as process improvements, employer branding efforts, workforce planning, and recruitment metrics, as assigned