Quality Control Manager

Location
South San Francisco, CA
Posted
May 04, 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 and eliminate the risk of needle-stick injury.

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 Quality Control Manager to join our growing South San Francisco team!

* Please note that we cannot sponsor Visas at this time.

Summary:

The QC Manager is responsible for testing clinical bulk and finished product at Vaxart. This position is also responsible for qualifying assays, establishing environmental monitoring program, the stability program, and managing contract testing laboratories. This person 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 EM/Microbiology staff to meet corporate production schedules as well as influencing related, cross-functional groups to meet these objectives.

Responsibilities:

  • Manage contract test labs.
  • Manage the environmental monitoring program.
  • Ensure that assays are qualified, and if needed, validated.
  • 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.
  • Oversee daily operation & address lab needs.
  • Responsible for resource management and initiating timely resource planning for the QC/Micro/EM team based on production forecasts and business needs.
  • Support and oversee Qualification activities at the Vaxart facility (Room classification and utilities)
  • 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, Facility, 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.
  • 50% or more of time is spent in work directly and closely related to carrying out exempt functions.
  • Other duties as assigned.
  • Monitor Environmental Monitoring and testing schedule, progress, data, and work quality.
  • Conduct troubleshooting and OOS investigations.
  • Oversee, QC Microbiology testing and method qualification in support of the GMP manufacturing schedule to include in-process and drug substance release (Bioburden, Endotoxin, and assay qualifications)
  • Write and revise Environmental Monitoring and Water Reports, Quality Control Methods, Standard Operating Procedures (SOPs), and Material Specifications
  • Participate in Quality Management Reviews
  • Work with team members to support the GMP QC Laboratory operations and build the infrastructure for a Commercial QC Microbiology laboratory

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 QC EM and microbiological samples.
  • Minimum of 5 years of experience working in GMP Environment.
  • 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, 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.