Sr. QC Analyst (CMO/External QC)

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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 Sr. QC Analyst to join our growing South San Francisco team!

Summary:

This position is primarily responsible for QC in-process, stability, release testing, qualifying and validating assays, author/review of assay qualification protocols, SOPs, and other controlled documents.

Responsibilities:

• Support external assay validation and transfer by drafting validation protocols and providing data to support final reports.
• Track QC Assay data and instrument performance trending on a timely manner.
• Attend project team meetings as the QC representative and works closely with the team to ensure on-time delivery.
• Maintain instrumentation and supporting documentation in a GMP compliant manner.
• Write, review and revise Assay Validation Protocols, Assay Transfer Protocol, and Validation and Assay Transfer Reports.
• Ensure quality standards are always met or exceeded.
• Communicate external assay transfer timelines to QC Manager(s).
• Provide or Organize Training Support for QC Analyst.
• Ensure that external assays are qualified, and if needed, validated.
• Ensure that deviation reports are written accurately and appropriately as they occur (external testing).

Requirements

• BS in a scientific discipline with 3+ years of regulated industrial analytical testing or QC experience, or equivalent combination of education and experience
• Sound understanding and knowledge of cell-based potency assays as performed in a commercial GMP QC laboratory.
• Experience with SoftMax and Gen5 data analysis software is a plus.
• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
• Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
• Computer proficiency as well as strong scientific and organizational skills.
• Ability to maintain flexible intellect and adjust to a dynamic work environment.
• Experience working in a regulated (GxP) environment and able to participate in Quality Systems.
• Demonstrated success working in a high-performing, results-driven environment.

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, 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.