Scientist/Sr. Scientist, Characterization

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Job description

About Us:

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 Scientist/Sr. Scientist, Characterization to join our growing South San Francisco team!

Summary:

The Scientist/Sr. Scientist, Characterization must have proven record of analytical development, characterization, hands on experience in using LCMS, and various analytical techniques to characterize adenovirus vaccines. The candidate independently develops analytical methods (including but not limited to different modes of chromatography, LCMS, CE, colorimetric and light-scattering technique) for characterization and quality control purpose. Additional responsibilities also include authorship of protocols, reports, and regulatory submissions.

Responsibilities:

• Design and implement characterization strategy for understanding the physicochemical properties, heterogeneity, and function of adenoviral vaccine product.
• Acts as a hands-on expert for characterization to guide process and analytical development to identify and justify critical quality attributes.
• Independently propose and develop analytical methods for characterization of adenovirus vaccine to support process development/characterization and the establishment of appropriate manufacturing control strategies.
• Provides appropriate oversight of project conducted externally by critically reviewing analytical development data, providing necessary guidance, and troubleshooting solutions to move project forward, reviewing and approving analytical development reports and analytical method SOP's.
• Authors protocols, reports, and regulatory submissions appropriately.
• Partners with process development scientists, CMC functional heads and project management to deliver the project milestones.

Requirements:

• PhD in Chemistry, Analytical Chemistry preferred, with 5+ years relevant industry experience; MS or BS with 15+ years of industry experience; (Pharma / Biotech / Analytical Testing) required.
• Extensive hands-on experience in using LCMS and various analytical techniques to characterize adenovirus vector and their conjugates is a must.
• Experience developing protein assay methodologies such as proteomics, peptide mapping by MS, H/UPLC, capillary electrophoresis, SEC, CEX, icIEF and/or oligosaccharide analyses is required.
• Prior experience in developing characterization of adenoviral vaccines to advance product understanding, process development and the establishment of control strategies.
• Problem solver with the ability to leverage novel analytical technologies to dive deeper and more broadly in advancing our knowledge of adenoviral vector physicochemical and biological properties to support product and process development.
• Experience working in a regulated (GLP / GMP) environment.
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to analytical method development and qualification/validation and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy.
• Self-starter with ability to map out project milestones, apply sound judgment, excellent project management and problem-solving skills to delivered desired outcomes within timelines.
• Adaptable fast learner with excellent skills for integrating and interpreting interdisciplinary connections.
• Able to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
• Extensive technical writing experience in drafting method protocols, SOP's, and reports.
• Strong interpersonal skills: ability to communicate effectively both verbally and in written formats.
• Attention to detail and excellent skills in record keeping / documentation.

Vaccination Requirement:

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.

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, 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.