Global Head, Vaccine CMC & Nonclinical Toxicology

PATH; Massachusetts; Hybrid; USD 320,000 - 380,000; Full time

Benefits offered by this job

Competitive salary and benefits

Hybrid Work Model

Job summary

PATH's Center for Vaccine Innovation and Access (CVIA) seeks a Global Head of Chemistry, Manufacturing and Controls (CMC) to lead CMC/NT activities across vaccine projects worldwide. You will shape development strategies, drive process development, analytics, formulation, fill, and quality control, and ensure regulatory readiness with WHO GMP/GLP standards.

You will mentor a team of CMC experts, manage cross-functional collaborations, perform due diligence on partners, and guide technology

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

• Provide strategic and technical guidance to CMC team members on process development, product analytics, formulation and fill, final manufacturing process and facility design and needs, and quality control thereof, investigational product supply and stability, as well as in vivo and in vitro safety and toxicity testing performed before and during the clinical development to demonstrate non-clinical safety and tolerability of candidate vaccine products.
• 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 (Product, Process, Method and Packaging) thereof.
• Prepare and review quality control guidelines and validation protocols for vaccine process, formulation, product analytical assay development, and in vivo and in vitro safety, toxicity testing and packaging validation.
• Evaluate industrial processes for robustness, cost efficiency, compliance, quality control, and health/safety/environmental requirements and consider how new tools, such as AI, can be applied.
• 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, including primary accountability for technical content and quality of regulatory documents submitted by CVIA.
• Conduct technical due diligence of potential partners and vendors for process development, manufacturing, quality control, and safety and toxicity testing.
• Review plans against quality control requirements including WHO Prequalification and stringent regulatory authority standards.
• As needed, 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.

Skills

CMC leadership

Vaccine/biologics experience

Regulatory knowledge

Team management

Communication skills

Travel willingness

Education

PhD in chemistry or vaccine-related field

Job description

PATH's Center for Vaccine Innovation and Access (CVIA) seeks a Global Head of Chemistry, Manufacturing and Controls (CMC) to lead CMC/NT activities across vaccine projects worldwide. You will shape development strategies, drive process development, analytics, formulation, fill, and quality control, and ensure regulatory readiness with WHO GMP/GLP standards.

You will mentor a team of CMC experts, manage cross-functional collaborations, perform due diligence on partners, and guide technology