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About the Role

PATH seeks a Global Head of Chemistry, Manufacturing and Controls, and Non-clinical Toxicology (Global Head of CMC) to provide leadership, management, operational excellence, and technical expertise to all CMC & NT activities within the CVIA portfolio. This role is responsible for assessing new partnership opportunities, ensuring adherence to GMP and GLP standards, and contributing to the development and delivery of lifesaving vaccines.

Responsibilities

Provide functional area-wide leadership and management of Chemistry, Manufacturing and Control, and Non-Clinical Toxicology functional activities.
Ensure on-time and on-budget delivery of CMC & NT-related project objectives and milestones.
Provide strategic and technical guidance to CMC team members on project teams.
Oversee CMC team preparation and review of reports for partners and donors.
Ensure CMC team support for regulatory submissions by authoring or reviewing CMC content.
Interact with partners to provide oversight, guidance, and evaluations of processes in development, laboratories and manufacturing facilities.
Prepare and review quality control guidelines and validation protocols.
Evaluate industrial processes for robustness, cost efficiency, compliance, quality control, and health/safety/environmental requirements.
Provide guidance for optimal process and technology transfer from R&D to commercial operations.
Perform technical review of CMC plans and technical documentation relative to vaccine manufacturing production, facilities and product analytics.
Conduct technical due diligence of potential partners and vendors.
Review plans against quality control requirements including WHO Prequalification and stringent regulatory authority standards.
Serve as CMC lead on more complex project(s) and/or lead CMC technical assistance projects.
Contribute to partner identification efforts to support product transfer to commercial manufacturers in LMICs.
Partner with other CVIA leaders to support the goals and objectives of vaccine development and introduction.
Develop strong partnership with cross-functional peers to ensure overall integrated development and introduction plans and tactics.
Ensure resource allocation across vaccine development and introduction projects, technical assistance projects, and change initiatives.
Develop and enforce functional area norms and standards to ensure quality of CMC & NT technical support.
Recruit, supervise, coach, and develop CMC & NT staff.

Requirements

15+ years of vaccine or biologics industry experience.
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.
Ability and willingness to travel domestically and internationally, up to 25% annually.
Must have legal authorization to work in PATH country office location.

Skills

Chemistry
Vaccine-related field of study
Process development
Product analytics
Formulation and fill
Manufacturing process and facility design
Quality control
Investigational product supply and stability
In vivo and in vitro safety and toxicity testing
Regulatory submissions (eCTD Modules 2.3 and 3)
WHO Good Manufacturing Practices (GMP)
Good Laboratory Practices (GLP)
Validation (Product, Process, Method and Packaging)
AI application in industrial processes
Process and technology transfer
Technical writing
Verbal communication
Interpersonal communication

Location

Remote (US state where PATH is registered)

Work Type

Hybrid
Remote

Experience Level

Senior management level

Education Level

Ph.D. or master’s in chemistry or vaccine-related field of study

Salary/Compensations

$320,000-$380,000

Benefits

Competitive salary
15 vacation days per year
11 holiday days per year
2 personal days per year
12 sick days per year
Medical and dental plans
Life insurance
Disability benefits
Retirement benefits

About the Company

PATH is a global nonprofit dedicated to achieving health equity.
With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing health challenges.
PATH’s Center for Vaccine Innovation and Access (CVIA) brings together our expertise across every stage of the long and complex process of vaccine research, development, and delivery to make lifesaving vaccines widely available to children and communities across the world.
CVIA’s current portfolio encompasses more than two dozen vaccines either in development or already in use to protect against fifteen different diseases.
Our focus is on vaccines to address the leading diseases that claim children’s lives worldwide: pneumonia, diarrheal disease, and malaria; as well as other global health priorities, such as polio and meningitis.
We work in partnership with national health ministries, pharmaceutical manufacturers, donors, international financing and regulatory organizations, and many others.
PATH has led numerous global partnerships, including the award-winning Meningitis Vaccine Project and the Malaria Vaccine Initiative, which helped develop the first malaria vaccine candidate recommended for pilot implementation.

Equal Opportunity

PATH is a diverse nonprofit organization that creates a culture of collaboration and partnership.