Global Head, Vaccine CMC & Toxicology (Remote)

PATH; Oregon (WI); Hybrid; USD 320,000 - 380,000; Full time

Benefits offered by this job

Competitive benefits

Job summary

PATH is a global nonprofit accelerating health equity through multisector partnerships and vaccine development. The Global Head of CMC and Non-clinical Toxicology leads CMC/NT across CVIA, shaping strategy, regulatory submissions, and cross-functional collaboration.

Requires 15+ years in vaccine/biologics, PhD/masters in chemistry or related field, and willingness to travel up to 25% domestically and internationally.

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 and align with other vaccine development and introduction leaders.
• Demonstrated senior management level capacity to manage diverse and varied job responsibilities.
• Excellent written (especially technical writing), verbal and interpersonal 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.

Responsibilities

• Functional leadership and management of CMC and NT activities within CVIA,ensuring on-time and on-budget delivery and compliance with PATH policies.
• Provide strategic and technical guidance on process development, product analytics, formulation and fill, and quality control.
• Oversee preparation and review of reports for partners and donors, including risk identification and mitigation.
• Ensure support for regulatory submissions (eCTD Modules 2.3 and 3).
• Interact with partners to oversee processes in development, laboratories and manufacturing facilities, including technology transfer.
• Prepare and review QA guidelines and validation protocols for vaccine processes and analyses.
• Evaluate industrial processes for robustness, cost efficiency, and compliance; explore AI applications.
• Provide guidance for optimal process and tech transfer from R&D to operations.
• Conduct due diligence of partners and vendors for process development and QA.
• Review plans against WHO Prequalification and regulatory standards.
• Lead complex CMC projects and cross-functional collaboration.
• Contribute to partner identification for product transfer to LMIC manufacturers.
• Management & Leadership: Be part of CVIA LT, develop cross-functional partnerships, allocate resources, enforce norms, and supervise staff.

Education

PhD or Master's in chemistry or vaccine-related field

Job description

PATH is a global nonprofit accelerating health equity through multisector partnerships and vaccine development. The Global Head of CMC and Non-clinical Toxicology leads CMC/NT across CVIA, shaping strategy, regulatory submissions, and cross-functional collaboration.

Requires 15+ years in vaccine/biologics, PhD/masters in chemistry or related field, and willingness to travel up to 25% domestically and internationally.