Global Head, Vaccine CMC & Nonclinical Toxicology

PATH; Washington (District of Columbia); Hybride; USD 320 000 - 380 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

PATH’s Center for Vaccine Innovation and Access seeks a Global Head of Chemistry, Manufacturing and Controls (CMC) and Non-clinical Toxicology to lead CMC and NT activities across vaccine candidates. You will provide strategic guidance on process development, analytics, formulation, and manufacturing while ensuring regulatory compliance and cross-functional collaboration.

The role requires 15+ years in vaccine/biologics, a PhD or Master’s in Chemistry, and willingness to travel up to 25%

Qualifications

• 15+ years of vaccine or biologics industry experience.
• Ph.D. or master’s in chemistry or vaccine-related field of study.
• Experience in method, equipment and process validation, and development and validation of product analytics in a cGMP regulated environment.
• Prefer previous work experience with low-resource setting country manufacturers.
• Reputation as a flexible team player with the ability to forge consensus in a project-based matrix organization.
• Demonstrated senior management level capacity to manage diverse and varied job responsibilities.
• Excellent written (technical) and verbal communication skills.
• Ability and willingness to travel domestically and internationally, up to 25% annually.
• Must have legal authorization to work in PATH country office location.

Responsabilités

• Lead CMC functional activities, ensuring on-time and on-budget delivery and compliance with WHO/GMP standards.
• Provide strategic and technical guidance on process development, product analytics, and manufacturing needs.
• Oversee preparation and review of reports for partners and donors, including risk identification and mitigation.
• Support regulatory submissions by authoring or reviewing CMC content.
• Interact with partners to evaluate development, manufacturing, and quality control processes.

Connaissances

Vaccine/biologics

CMC leadership

Regulatory/documentation

Team management

Strong communication

Travel up to 25%

Work authorization

Formation

PhD in Chemistry

Master's in Chemistry

Vaccine-related degree

Description du poste

PATH’s Center for Vaccine Innovation and Access seeks a Global Head of Chemistry, Manufacturing and Controls (CMC) and Non-clinical Toxicology to lead CMC and NT activities across vaccine candidates. You will provide strategic guidance on process development, analytics, formulation, and manufacturing while ensuring regulatory compliance and cross-functional collaboration.

The role requires 15+ years in vaccine/biologics, a PhD or Master’s in Chemistry, and willingness to travel up to 25%