Scientist/Sr. Scientist (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 and eliminate the risk of needle-stick injury.
The Senior Scientist will design, 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.
Multiple positions are available.
- Independently designs, develops and optimizes cell-based assays such as infectivity, transgene expression, and biopotency assays to support product development and characterization.
- Performs DOE studies to establish assay acceptance criteria to support method validation and product specifications applying appropriate statistical tools to comply with regulatory guidelines.
- Evaluates new assay technologies and innovates novel assay methodologies.
- Authors and reviews protocols, development reports, standard operating procedures, and other technical reports.
- Responsible for understanding and applying data generated from experiments and literature to support process development activities.
- Supports and trains staff as appropriate in laboratory activities. 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.
- PhD degree in Cell biology, Biochemistry, or related disciplines with 8+ 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 required.
- Good understanding of statistical methods/tools for data analysis is required.
- 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.