PATH is a global organization that works to accelerate health equity by bringing together institutions, businesses, investors, and individuals to solve the world’s most pressing health challenges. With expertise in science, market development, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide. Learn more at www.path.org. 

PATH has a tremendous track record and technical leadership in vaccine development and introduction and has now created and branded a whole platform approach with significant core funding to be even more agile, responsive, effective, and sustainable in the Center for Vaccine Innovation and Access (CVIA). PATH’s work on vaccine development and introduction encompasses activities including discovery, preclinical development, clinical research and development, process development and manufacturing, regulatory and vaccine introduction. Our portfolio currently encompasses over 25 candidates and vaccines in the following disease areas—Malaria, Enteric and Diarrheal Diseases, Polio, Respiratory Tract Infections and Meningitis, HPV and Vector-borne viral diseases (e.g., Japanese Encephalitis)—and in the cross-cutting area of Maternal Immunization.

Towards this mission, PATH CVIA is looking to hire a Technical Program Advisor, CMC. Reporting to the Global Head, CVIA CMC Functional Area, this person’s primary responsibilities will include providing guidance and accountability for deliverables on process development, tech transfer, and manufacturing activities for developing and mature vaccines. This includes process and analytical development, scale up, tech transfer, validation, supply chain of manufacturing processes for vaccines, and collaborating with LMIC vaccine manufacturing partners on facility design and engineering needs for capacity expansion, amongst other duties.  

RESPONSIBILITIES: 

• Plan, lead, deliver, and demonstrate accountability for all CMC aspects of vaccine development from preclinical to post-launch commitments and the WHO pre-qualification process.
• Responsible for working with the Project Director(s), project team members, and partners to develop, execute and deliver the CMC strategy in integrated product development and lifecycle management plans consistent with the overall project goals across the entire CVIA CMC portfolio.
• Serve as primary point-of-contact with CMC partners and CMOs in the context of process development, technology/product transfers and scale-up of complex vaccine manufacturing/testing.
• Lead and perform technical due diligence as required for recommending suitable approaches for a successful scale-up and cost-effective manufacturing process.
• Be able to actively contribute or lead technology transfer efforts post Phase II proof of concept.
• Assist LMIC vaccine manufacturing partners with facility design and engineering needs for capacity expansion that meet international regulatory and compliance standards.
• Provide input in approaches for operational excellence for capacity building in support of sustainable supply of vaccines that meets demand.
• Interact closely with internal and external stakeholders in planning and implementation of transition for vaccines from pilot plant to commercial manufacturing scale.
• Represent CMC function on project teams, task forces, audits and business or technical meetings with internal and external groups.
• Write CMC sections for regulatory filings and reviews for final submission. Work closely with internal and external stakeholders.
• Become a resource and a trusted partner by way of building strong collaborative professional relationship with PATH CVIA internal project teams, donors, and vaccine manufactures.
• Contribute to grant proposals for funding from donors/agencies and write annual progress reports.
• Contribute to developing budgets for labor and capital expenditures.

Required Skills Required Experience

• Master’s degree in Biochemical/Chemical Engineering required; PhD in Biological Sciences or Biochemical Engineering strongly preferred.
• Minimum of 15+ years of experience in upstream and downstream process development and validation or tech transfer of vaccines or other biological products (Monoclonal antibodies, viruses, recombinant proteins) required with at least 10 years of industry experience.
• Strong hands-on knowledge of at least two of the following disciplines, with working knowledge of the others: Cell banking, Upstream processing, Purification, Formulation and Packaging, Process Engineering, Facility Engineering, Analytical Development, QC, Regulatory CMC writing, Tech Transfer and Scale up.
• Ability to understand and identify risks associated with manufacturing and risk mitigating solutions for sustainable product supply and to increase robustness and capacity for manufacturing.
• Participate in partner selection and due diligence activities.
• Identify personnel needs, train and guide personnel at partner/vendor sites as appropriate. Ability to influence without direct authority is essential, as is ability to work with partners in diverse geographic regions and cultures. Although our official language is English, communication capability in other foreign language is a plus. Mandarin and Cantonese language skills are a distinct advantage.
• Willingness to travel (international) approximately 30%.

_Must have legal authorization to work in the designated PATH office country. _

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PATH is dedicated to building an inclusive workforce where diversity is valued.  

PATH is an equal opportunity employer. Every qualified applicant will be considered for employment. PATH does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.