Quality Control Manager

Location
South San Francisco, CA
Posted
Sep 26, 2021
Discipline
Quality, Quality Control
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract

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 QC Manager to join our growing South San Francisco team!

Summary:

The Quality Control Manager is responsible for testing clinical bulk and finished products at Vaxart. This position is also responsible for qualifying assays, the stability program, and managing contract testing laboratories. This QC Manager develops the testing schedules and contributes to the development of departmental objectives. In meeting these goals, the Manager of Quality Control will ensure that the facilities maintain a cGMP compliant state. In addition, this position is responsible for managing the Quality Control staff to meet corporate production schedules as well as influencing related, cross-functional groups to meet these objectives.

Responsibilities:

  • Oversee, qualify, and perform as needed, analytical assays to support the in-process and release testing of bulk drug substance and drug product.
  • Manage the bulk drug substance and bulk drug substance stability testing.
  • Manage contract test labs.
  • Provide analytical testing support to Analytical Development as needed.
  • Ensure that assays are qualified, and if needed, validated.
  • Demonstrated knowledge and experience performing assays used to assess the quality of biopharmaceuticals, including HPLC, SEC, KP, ELISA, q-PCR based residual DNA and UV/Vis.
  • Build and maintain a staff that is both technically qualified and well trained in cGMP, while providing a motivating environment and opportunities for their professional advancement in a safety conscious environment.
  • Define, implement, and optimize testing plans while keeping within the corporate budget.
  • Ensure consistent product quality through appropriate testing programs.
  • Lead the effort of process definition, improvement and troubleshooting by appropriate use of resources and by influencing other groups such as Analytical Development, Manufacturing, and Quality Assurance.
  • Develop, implement, and update all Quality Control SOPs, testing records and other documentation needed for cGMP compliance.
  • Ensure that deviation reports are written accurately and appropriately as they occur. Track and implement corrective actions.
  • Provide reasoned and timely input to Management and others in developing a structure and vision for Quality Control at Vaxart.
  • Contribute to new facilities design and existing facility modifications, as necessary, as part of the project team.
  • Provide a safe working environment for employees.
  • Evaluate employee efficiency and productivity.
  • Customarily and regularly exercises discretion and independent judgment in the performance of the duties described above.
  • Ability to lead equipment installation, validation, calibration, and GLP and GMP qualification.
  • Develop, implement, and improve quality programs to meet worldwide standards for safety, efficacy, and quality.
  • Other duties as assigned.

Requirements:

  • B.S. in Biological Sciences, Pharmaceutics, Engineering, or equivalent work experience.
  • Minimum of 8 years of experience in the biopharmaceutical industry.
  • Minimum of 5 years of experience in testing biopharmaceuticals; virus testing preferred.
  • Minimum of 3 year of personnel management experience.
  • Demonstrated ability to work and communicate collaboratively with other independent workers and to train workers in new procedures, as necessary.
  • Must have strong critical thinking skills, initiative, integrity, and strong interpersonal and leadership skills.
  • The ability to communicate clearly and precisely, both orally and in writing, is essential.
  • Highly motivated, able to multi-task, strict attention to detail and open to be responsible for successful execution of tasks.
  • Ability to problem solve, think critically, and troubleshoot while working independently.
  • Extensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development with prior experience through commercialization is preferred.
  • Ability to safely lift at least 25 pounds.

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.