Global Head, Vaccine CMC & Toxicology (Remote)

PATH; Seattle (WA); Hybrid; USD 320,000 - 380,000; Full time

Benefits offered by this job

Hybrid work model

Remote work eligible

Job summary

PATH seeks a Global Head of Chemistry, Manufacturing and Controls (CMC) and Non-clinical Toxicology to lead CMC/NT activities across a program portfolio, ensuring on-time, on-budget delivery and regulatory readiness. The role drives process development, analytics, formulation, fill, validation, and tech transfer for vaccines.

The position requires 15+ years in vaccine/biologics, advanced degree in chemistry, and strong leadership.

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.

Responsibilities

• Provide strategic and technical guidance to CMC team members on process development, product analytics, formulation and fill, final manufacturing process and facility design.
• Oversee CMC team preparation and review of reports for partners and donors including project status, risk identification, and potential mitigation strategies.
• Ensure CMC team support for regulatory submissions such as eCTD Modules 2.3 and 3, by authoring or reviewing CMC content.
• Interact with partners to provide oversight, guidance, and evaluations of processes in development, laboratories and manufacturing facilities, including process development, product analytics, formulation and fill, manufacturing, and quality control and Validation.

Skills

Vaccine leadership

People management

Scientific communication

Regulatory understanding

Travel willingness

Education

Ph.D. or MS in chemistry or vaccine-related field

Job description

PATH seeks a Global Head of Chemistry, Manufacturing and Controls (CMC) and Non-clinical Toxicology to lead CMC/NT activities across a program portfolio, ensuring on-time, on-budget delivery and regulatory readiness. The role drives process development, analytics, formulation, fill, validation, and tech transfer for vaccines.

The position requires 15+ years in vaccine/biologics, advanced degree in chemistry, and strong leadership.