Associate Director/Director, Analytical Development
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 an Associate Director/Director, Analytical Separation to join our growing South San Francisco team!
The Scientist (Bioanalytical Separation), is responsible for understanding, designing, executing, and reporting analytical bioseparations techniques with a focus on both Capillary Electrophoresis (CE) and HPLC-based protein characterization for development and manufacture of Ad5 vectors used for oral vaccines. Familiarity with capillary and column chromatography methods including IEF, SDS PAGE, SEC, reverse phase, analytical ion-exchange, glycosylation profiling, and other techniques are required. You will be responsible for evaluating existing methods and develop new methods appropriate for product and process characterization, release testing, and for in-process testing of product and intermediates. The successful candidate will be expected to work with in-house and partnering QC organizations for assay transfer and assay validation, and with the process development group to support process improvements. Other responsibilities will also include training and managing junior scientists, setting up a lab and establishing PM and calibration protocols; and effective communication with management. This position is one of 3 group leaders reporting to the head of Analytical Development and focusing on unique analytical areas.
- Manages lab based Bioanalytical separations analytical development staff and contract service partners to provide assay support for development activities, and product characterization and in process test methods for transfer to manufacturing and QC. Design and execute experimental protocols for assay development.
- Writes and/or reviews protocols, assay development reports, batch records, standard operating procedures, and other technical reports in support of manufacturing and process tech transfer with a focus on capillary and analytical HPLC techniques. Assures that results are properly archived and communicated.
- Responsible for understanding and applying data generated from experiments and literature used to modify/optimize process parameters. Evaluates new technology and procedures.
- Manages and trains staff as appropriate in laboratory activities. Assures that training and compliance records for themselves and staff are up to date and appropriate. Assures that all safety procedures are followed.
- Proactively communicates with internal and external stakeholders. Establish and foster relationships with contract manufacturing organizations.
- Ph.D. or M.S. in Analytical Chemistry, biochemistry, molecular biology or related scientific disciplines with 8 years of experience in analytical development and 3 years of management experience.
- Experience with mammalian cell culture in a GMP environment.
- Prior experience in production and purification of viral products.
- Sterile techniques and hazardous/ infectious material handling experience.
- General or direct supervision to exempt employees and/or skilled nonexempt employees.
- Excellent written and verbal communication skills.
- Knowledge of QC issues.
Vaxart has implemented a mandatory COVID-19 vaccination policy which requires our employees to be fully vaccinated against COVID as a condition of employment. Vaxart will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. Vaxart prioritizes sound science and available facts to best ensure the ongoing safety of our employees and the community.
Vaxart offers team members a competitive compensation and benefits package, including a robust health plan, 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, and 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.