Senior Research and Development Officer Vaccine and Drug Formulation

PATH is currently recruiting for a Senior Research and Development Officer to work in both the Medical Devices and Health Technologies Program (MDHT) and within the Center for Vaccine Innovation and Access (CVIA) Chemistry and Manufacturing Controls (CMC) programs.

The Medical Devices and Health Technologies (MDHT) program at PATH develops, advances, and facilitates introduction of technologies for priority health needs around the world. This includes development of novel formulations which enable improved vaccine access through improved thermostability or alternate delivery routes. 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.

Formulation development involves development of critical stability indicating test methods, qualification and validation of test methods, accelerated and real time stability studies and support of technology transfer to manufacturing partners. This Senior Research and Development Officer role includes identifying new opportunities to expand and diversify PATH's formulation technologies portfolio through identification of novel, innovative approaches for vaccine and drug delivery, support of analytical method technology transfer to manufacturing partners, support through method validation and regulatory submission, managing and building relationships with external partners.

PATH is seeking a candidate with a strong technical background to provide strategic and technical oversight for vaccine and drug formulation and R&D activities within the MDHT and CVIA CMC programs. This position is expected to contribute to grant proposal development, identify funding opportunities for new and transformative research and foster new collaborations. The position will manage technical teams providing guidance on process and analytical development, scale up, tech transfer, validation, and collaborating with low- and middle-income countries (LMIC) vaccine manufacturing partners. This position will manage and build relationships with external partners and provide oversight of internal lab staff.

Responsibilities:

• Stay up to date with recent technology advancements, identify vaccine and drug formulation needs, and create research strategies.

• Plan, manage, and oversee product development activities and preclinical research.

• Research technical topics through literature reviews and informational interviews and synthesize information to inform project strategy.

• Design, draft, and review research protocols and findings, publications, Target Product Profiles, project updates, guidance documents, presentations, and donor reports.

• Provide clear and concise data analyses and technical reports for internal and external audiences.

• Identify and pursue new funding or partnership opportunities and contribute to development and pursuit of funding proposals.

• Present data at scientific meetings and represent PATH at international, regional, and national meetings.

• In coordination with the project director(s), program advisor(s) and project team lead, work to develop, execute, and deliver the CMC strategy in integrated product development and lifecycle management plans consistent with the overall project goals across the CVIA CMC portfolio.

Required Skills and Experience:

• Advanced degree in microbiology, biochemistry, chemistry, immunology or related field required.

• PhD with seven to ten years of industry or academic/non-profit experience

• Experience inplanning, design, and execution of preclinical vaccine or drug studies and the interpretation of experimental data.

• Experience in vaccine and drug formulation development, immunological assay standardization, qualification, and validation desirable.

• Broad knowledge on vaccine delivery systems and adjuvant formulations.

• A high degree of initiative, independent judgment, and resourcefulness.

• Proven experience with formulation, 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.

• Demonstrated experience with manufacturing process characterization and evaluation, such as design, execution, and analysis of DoEs.

• Strong written and verbal communication skills for diverse audiences, including experience writing grant proposals, technical reports, journal articles and slide presentations.

• Demonstrated success working effectively in a multidisciplinary, international project team and self-directed work environment.

• Experience developing research partnership strategies with external collaborators, including budgeting, timeline and scope development.

• Experience managing internal and external project team meetings to be efficient, effective, and produce clear decisions and action plans.

• Experience reviewing and providing strategic input on project timelines with input from other key team members.

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

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 $144,000-$180,000. The final salary is based on a variety of objective factors.

PATH provides a comprehensive benefit package that includes 15 vacation, 10 holiday, 2 personal, and 12 sick days per year; medical and dental plans; life insurance; and disability and retirement benefits. For more details click here.

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