Job Information
Access to Advanced Health Institute Principal Scientist (RNA Vaccine Development) in Seattle, Washington
Access to Advanced Health Institute is a Seattle-based nonprofit biotech institute that is undergoing a transformation to lead a global coalition to fight infectious disease and address health disparities and inequities worldwide. We think it's unfair that where a person lives or how much money they make dictates their access to life-changing medicine. We're looking for people who want to join us in increasing accessibility to tools that harness the immune system and allow a healthy life, free of illness and disease, regardless of geography or socio-economic status -- from compassion and collaboration come change.
We will serve as a center for innovation and collaboration in vaccine and cancer immunotherapy research and development, early-phase GMP manufacturing, and training the next generation of scientists and manufacturing teams to achieve our mission. This is where the high-quality science of an academic research organization and the product-development capabilities of a biotech company meet.* *
**Summary
**As a Principal Scientist, you will play a critical role in advancing our RNA vaccine candidates from preclinical research to phase 2 clinical trials. Working under the Director of the RNA Program and closely with the CEO, you will collaborate with cross-functional teams, including research, manufacturing, product development, clinical development, and regulatory affairs to ensure successful RNA vaccine development. Your expertise will be instrumental in achieving regulatory milestones and ultimately bringing safe and effective vaccines to patients worldwide.
*Responsibilities *
Vaccine Development Strategy:
- With the Director, RNA Program and AAHI Senior Scientific Leadership, develop and execute a comprehensive strategy for advancing vaccine candidates from preclinical stages through phase 2 clinical trials.
- Collaborate with internal stakeholders to align development plans with corporate goals, external partner/funder demands, and regulatory requirements.
Identify project risks, maintain a project risk register, design and implement risk mitigation strategies.
Preclinical Research Oversight:
Work closely with preclinical study leads, both internal and external, to design IND-enabling preclinical animal studies.
Communicate plans for key preclinical studies for funders/stakeholders, documenting study design approvals, key decisions, and deviations from the approved plans.
Product Developmentand Manufacturing:
Interact with cross-functional teams (Product Development, Quality Control, Quality Assurance, Manufacturing, Clinical Regulatory) downstream to successfully push products forward.
- Serve as a central information source, identifying and enabling appropriate cross-team communication as needed to advance complex cross-functional vaccine development projects.
Work closely with department managers to develop and maintain appropriate timelines; work with QC/MFG schedules to deliver orders on time and efficiently with quality.
Regulatory Affairs and IND Application:
Oversee the quality and collection of preclinical and manufacturing reports, documents, and data in preparation for submission of the Investigational