Tracking Code11473Job Description
*This position may be based in any PATH location*
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) spans every stage of the complex process of vaccine research, development, and introduction to make lifesaving vaccines widely available to women, 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 18 different diseases, including diarrheal disease, malaria, meningitis, pneumonia, polio, and COVID. 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 world’s first malaria vaccine recently recommended by the WHO. 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. Over 25 candidates and vaccines are currently in our portfolio 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, Yellow Fever) – and in the cross-cutting areas of Maternal Immunization and Immunization Systems Strengthening.
PATH is currently recruiting for a Technical Program Advisor, CMC. Reporting to the Global Head, CVIA CMC Functional Area, the Technical Program Advisor’s primary responsibilities will include providing guidance and accountability for deliverables on process development, tech transfer, and manufacturing activities for polio vaccines. This includes process and analytical development, scale up, tech transfer, validation, supply chain of manufacturing processes for vaccines, and collaborating with Low and Middle Income Countries (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.
- Lead CMC team composed of subject matter experts in quality and regulatory to deliver all manufacturing components of early and phase III vaccine development.
- 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.
- Responsible for contracts and sub awards in CMC functional area.
- Contribute to grant proposals for funding from donors/agencies and write annual progress reports.
- Contribute to developing budgets for labor and capital expenditures.
Required Experience
- Master’s degree in Biochemical or 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.
- Previous experience with polio vaccine manufacturing a distinct advantage.
- 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.
- Strong project management experience with project management certification preferred.
- Experience participating in partner selection and due diligence activities.
- Ability to identify personnel needs, train and guide personnel at partner and 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.
- Ability and willingness to travel internationally approximately 30%.
- Must have legal authorization to work in the country of PATH location.
COVID-19 Vaccine Requirement:
PATH has instituted a COVID-19 vaccine mandate for all employees, interns, consultants, and temporary staff based in the United States. Individuals selected for job opportunities in the United States must be fully vaccinated, and show proof of vaccination status, upon hire. Individuals are considered fully vaccinated 2 weeks after their second dose in a 2-dose series, such as Pfizer or Moderna, or 2 weeks after a single-dose vaccine, such as Johnson & Johnson. Individuals with medical issues or sincerely held religious beliefs that prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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, gender identity or orientation, 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.
Job Location
Worldwide-Any PATH location in Asia, Africa, Europe, United States
Company Location
Worldwide-Any Existing PATH Office (Worldwide)
Position TypeFull-Time/Regular
