Global Head, Vaccine CMC & Nonclinical Toxicology

PATH; New York (NY); Hybrid; USD 320,000 - 380,000; Full time

Job summary

PATH's Center for Vaccine Innovation and Access (CVIA) seeks a Global Head of Chemistry, Manufacturing and Controls, and Non-clinical Toxicology to lead CMC and NT activities for CVIA vaccine programs. This senior role drives strategy, operational excellence, and cross-functional collaboration with partners and donors to ensure timely, compliant development.

The candidate will oversee process development, analytics, validation, regulatory submissions, and technology transfer, with travel up to

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.

Responsibilities

• Lead Chemistry, Manufacturing and Controls (CMC) and Non-Clinical Toxicology activities across CVIA projects.
• Provide strategic and technical guidance on process development, analytics, formulation and fill, and manufacturing needs.
• Review plans and regulatory documents for CMC content and enable timely regulatory submissions.
• Oversee partner interaction, due diligence, and technology transfer to manufacturing partners.

Skills

Vaccine industry experience

PhD in Chemistry

Process validation

Regulatory compliance

Education

PhD in Chemistry

Master's in Chemistry

Job description

PATH's Center for Vaccine Innovation and Access (CVIA) seeks a Global Head of Chemistry, Manufacturing and Controls, and Non-clinical Toxicology to lead CMC and NT activities for CVIA vaccine programs. This senior role drives strategy, operational excellence, and cross-functional collaboration with partners and donors to ensure timely, compliant development.

The candidate will oversee process development, analytics, validation, regulatory submissions, and technology transfer, with travel up to