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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 heath 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.

PATH is currently recruiting for a CMC Technical Officer to provide tactical and operational support for the Polio vaccine project.

Responsibilities

Process Development, Scale up, Technology Transfer

• Coordinate the technology transfer of viral vaccine manufacturing processes between manufacturers covering process and analytical transfer at full production scale.
• Work with polio vaccine manufacturing partners in Low- and Middle-Income Countries (LMICs) to conduct manufacturing and analytical data analysis, including translation of results into decisions related to CMC development and manufacturing procedures. Review manufacturing and CMC development data to ensure accuracy, validity, and sufficiency for optimization and scale-up of the manufacturing and analytical processes under Good Manufacturing Practices (GMP).
• Support regulatory submissions such as eCTD Modules 2.3 and 3, by authoring or coordinating the authorship of CMC content.
• Participate in process troubleshooting and identify root causes of deviations.
• Periodically track and trend stability data from manufacturing partners.

Clinical Supply

• Accountable for clinical supply readiness and shipment from manufacturing partners to clinical sites.
• Assess clinical supply availability, formulate strategy and provide oversight for expiry dating, material availability, and supply demand.

Strategy

• Participate in the establishment of short- and long-term CMC development and manufacturing strategies, including facilities allocation and release testing.
• Prepare and review reports for partners and donors including project status, risk identification, and potential mitigation strategies.

Required skills and experience

• PhD and a minimum of 5-7 years late-stage process development or manufacturing experience in pharma highly desired; or a Master's degree and a minimum of 8-10 years late-stage process development or manufacturing experience required.
• Experience performing CMC manufacturing and compliance activities including gap analysis and risk assessments. Experience with process validation required.
• Demonstrated current working experience with cGMP.
• Proven experience with assay development, qualification, and validation. Must be able to review and edit assay validation protocols and reports. Experience with assays for viral vaccines, such as viral culture potency assays, PCR, etc. Next Generation Sequency familiarity preferred.
• Demonstrated experience with manufacturing process characterization and evaluation, such as design, execution, and analysis of DoEs.
• Hands-on experience with viral vaccine upstream and/or downstream process development and manufacturing is required; working knowledge of viral vaccine formulation and filling is desirable.
• Strong communication skills for project reports and funder engagements, including technical reports and slide presentations.
• Proven experience authoring and reviewing CMC content of regulatory submission technical documentation.
• Knowledge and exposure of technology transfer to ensure transfers are successful, such as authorship of analytical comparability protocols and tech transfer reports.
• Experience authoring subcontractor scopes of work with external manufacturers, including budgeting. Experience contracting with CDMOs highly desired.
• Understanding implications of release criteria on overall program development highly desired.
• Proficiency in Microsoft Office Suite (Teams, Outlook, Word, PowerPoint).
• Must have legal authorization to work in the US, Belgium, Switzerland, UK, or India. Fully remote candidates in these locations will be considered.

PATH is a diverse nonprofit organization that creates a culture of collaboration and partnership. Learn more about the impact you can make globally .

We offer our employees a competitive salary and generous benefits. For candidates based in the U.S., the annual salary range for this position is $120,000-$150,000. The final salary is based on a variety of objective factors. PATH provides a comprehensive benefit package that includes 15 vacation, 11 holiday, 2 personal and 12 sick days per year; medical and dental plans; life insurance; disability and retirement benefits. For more details click .

Hybrid Work

PATH operates within a hybrid workplace model unless otherwise noted. Hybrid employees must reside within commuting distance to one of our PATH offices. PATH's US offices are located in Seattle, WA and Washington, DC. Fully remote candidates will be considered.

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, caste, 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.