Sr. QC Analyst

Location
South San Francisco, CA
Posted
Sep 26, 2021
Discipline
Quality, Quality Control
Hotbed
Biotech Bay
Required Education
Bachelors 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 a Sr. QC Analyst to join our growing South San Francisco team!

Summary:

The Sr. QC Analyst is responsible for performing drug substance and drug product in-process, release, and stability testing activities in support of CGMP manufacturing of clinical trial materials. The QC Analyst is also responsible for providing support to R&D for analytical development and other activities as assigned by the supervisor.

Responsibilities:

  • Provides QC support to development and manufacturing in the form of CGMP assay support involving release and stability testing.
  • Performs analytical development and characterization for bulk DS and final DP.
  • Performs product characterization activities, including potency assays, drug product physical characterization, and stability assessment.
  • Acquires, installs, modifies, maintains, and supports QC equipment and performs work necessary to implement procedures appropriate for analysis of drug substance and drug product clinical trial and development materials. Maintains the QC laboratory.
  • Troubleshoots assay/equipment failures when necessary and under supervision of the Director of Quality Control.
  • Evaluate test data against defined criteria and specifications.
  • Work with the quality control management team to continuously improve the quality, compliance, and efficiency of QC operations.
  • Demonstrated knowledge and experience performing assays used to assess the quality of biopharmaceuticals, including KP, Osmolality, HPLC, qPCR, q-PCR based residual DNA and UV/Vis.
  • Experience in Test Method Validation and transfer of test method between Analytical Development and Quality Control.
  • Experience participating in laboratory investigations of Invalid, OOS/OOT results and CAPA initiation.
  • Analyzes and documents results of test methods following CGMP guidelines for reporting test results. This involves method and CGMP training, maintaining a compliant laboratory notebook and utilizing CGMP forms for data reporting.
  • Assists and trains other employees in proper use of procedures and analytical equipment.

Requirements:

  • BS/MS degree in a scientific discipline.
  • 7 years of relevant industry experience, including 5 years of Quality Control experience.
  • 5 years working experience in a cGMP environment.
  • Experience with viral vaccine product processing or analytical development/quality control.
  • Experience with QC support to produce drug products, preferably with live viruses.
  • Mechanical aptitude to operate and maintain complex equipment.
  • Demonstrated ability to work and communicate collaboratively with other independent workers and to train workers in new procedures, as necessary.

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.