Associate Director/Director, Bioassay

Location
South San Francisco, CA
Posted
Jul 03, 2021
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time

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 an Associate Director or Director (Bioassay) to join our growing South San Francisco team!

Summary:

The Associate Director/Director, Bioassay will lead development of assays for determination of 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 desired. Technical knowledge of genomic analysis, quantitative PCR and NGS assays for viral characterization is a strong plus. 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.

Responsibilities:

  • Lead a group of scientists and associates responsible for bioassay and molecular method development and phase appropriate method qualification/validation for oral vaccine programs.
  • Lead design, development and optimization of cell-based assays such as infectivity, transgene expression, and biopotency assays to support product development and characterization.
  • Apply statistical approaches to evaluating potency data based on USP chapters on Bioassay and for design of experiments (DOE).
  • Implement industry best practices and evaluate emerging technologies in potency assay development and support improvements to existing methodologies.
  • Work collaboratively with QC team to support method transfer and trouble shoot assay issues.
  • Author and review protocols, development reports, standard operating procedures, and other technical reports.
  • Work collaboratively with Research, Development, QC and other functional groups.
  • Proactively communicate with internal and external stakeholders.

Requirements:

  • PhD degree in Cell biology, Molecular Biology, Biochemistry, or related disciplines with 10+ years of experience, preferably in biotech or pharma industry with primary focus on biologics.
  • Extensive experience with the design, development, optimization and qualification of cell-based potency assays to reflect the mechanism of action and relative potency determination.
  • Experience with cytotoxicity assays, ELISA, Flow Cytometry, Western Blots, and cell-based proliferation assays is required.
  • Excellent critical thinking and scientific acumen, with a demonstrated ability to analyze, interpret, and clearly communicate complex data.
  • Sound understanding of regulatory requirements including compendial requirements as well as requirements associated with the assessment of critical quality attributes, control strategies, stability, and comparability as outlined in ICH Guidelines and FDA guidance documents.
  • Demonstrated experience managing and mentoring direct reports.
  • Experience with Mammalian cell culture and production of viral vectors is a strong plus.
  • Team player with good interpersonal and organizational skills.

Vaxart offers team members a competitive compensation and benefits package, including a bonus program, stock options, 401(k) 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.