Research Associate, Bioassay
Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration.
Vaxart has demonstrated that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immuno-oncology indication.
Our mission is the promotion of global health through the development of effective vaccines that can be administered by tablet rather than by injection, providing for the simple and efficient distribution and administration of safe vaccines in any setting.
We are looking for a Research Associate (Bioassay) to join our growing South San Francisco team!
The Research Associate will develop and qualify analytical methods for biopotency and viral vector characterization for development and manufacture of recombinant Ad5 vectors used for oral vaccines. Experience with cell-based assays such as infectivity, transgene expression and potency determination is strongly preferred. Support existing methods and development of new methods appropriate for product and process characterization, release testing, and for in-process testing of product and intermediates.
- Develops and optimizes cell-based assays such as infectivity, transgene expression, and biopotency assays to support product development and characterization under direction from Supervisor.
- Performs DOE studies to establish assay acceptance criteria to support method validation and product specifications applying appropriate statistical tools to comply with regulatory guidelines.
- Authors development reports, standard operating procedures, and other technical reports.
- Assures that training and compliance records for themselves are up to date and appropriate.
- Proactively communicates with internal and external stakeholders and supervisor, as well as peers.
- Master’s/Bachelor’s degree in Cell biology, Biochemistry, or related disciplines with 2-5 years of experience, preferably in biotech or pharma industry with primary focus on biologics.
- Knowledge of FDA, cGMP, and ICH regulatory requirements in the context of bioassay/potency assay development and qualification is desired.
- Experience with method validation and transfer to in-house QC is desired.
- Good understanding of statistical methods/tools for data analysis is desired.
- Experience with Mammalian cell culture and production of viral vectors is a strong plus.
- Team player, good interpersonal and organizational skills.
- Excellent written and oral communication skills is required.
Vaxart offers team members a competitive compensation and benefits package, including a bonus program, stock options, 401K with employer matching, tuition assistance, and work life balance.
Vaxart is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include: recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, layoff or termination. Vaxart does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by federal, state or local law, ordinance or regulation.