Upstream Manufacturing Associate III
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 an Upstream Manufacturing Associate III to join our growing South San Francisco team!
* Please note that we cannot sponsor Visas at this time.
The Upstream Manufacturing Associate III will follow current Good manufacturing Practices (cGMPs) and adhere to Vaxart Quality systems in the execution of Drug Substance Manufacturing Operations. The Manufacturing Associate III will execute Drug Substance Manufacturing Operations such buffer preparation, perfusion, cells infection, cells transfection, Harvest, harvest clarification, filtration, and aseptic technique operations.
This person executes the Upstream activities and contributes to the development of departmental objectives. In meeting these goals, the Upstream Manufacturing Associate III will ensure that the downstream activities are completed in a GMP compliant manner. The Upstream Manufacturing Associate III is expected to support and lead Upstream timelines and daily operations as required to meet accelerated COVID19 and other vaccine manufacturing schedules or resolve problems. Communicates progress to the manufacturing lead, manufacturing manager, Quality Assurance, Project Management, and other organization stakeholders as required.
- Performs and supports buffer preparation and Upstream Drug Substance GMP Manufacturing operations.
- Helps to identify process improvements.
- Helps to identify documentation improvements for Standard Operating Procedures (SOPs), batch records (BRs), material specifications and other documentation needed for cGMP compliance.
- Experience with a minimum of 5 year of cell culture operation of bioreactors preferred.
- Experience with single use technology (SUT) preferred.
- Experience with cell thaw, cell passaging, bioreactor inoculation, cells infection, transfection, clarification, harvest, filtration, and aseptic technique operations.
- Support deviation investigations as needed.
- Support implementation of new technology and procedures into upstream manufacturing.
- Train staff in Upstream Operations and other manufacturing activities as needed.
- Defines, implements and optimizes Upstream Manufacturing Operations to successfully achieve production timelines.
- Supports the effort of upstream process definition, improvement and troubleshooting by appropriate use of manufacturing resources and by influencing other groups such as Materials Management, Process Development, Quality Control, and Quality Assurance.
- Develops, implements, and streamline BR’s, SOP’s, Forms, Logs and other manufacturing documentation under cGMP compliance and Quality focus.
- Initiates deviation reports (DRs) or supports discrepancy investigations per Vaxart Quality systems in a timely manner.
- Performs and executes other duties as assigned by the management team.
- Actively coaches and mentor manufacturing junior associates.
- B.S. in Biological Sciences, Pharmaceutics, Engineering, or equivalent work experience.
- Minimum of 5-8 years of experience in the biopharmaceutical industry.
- Minimum of 4 years of experience in the manufacture of Bulk Drug Substance based on cell culture production.
- Experience with the set-up and operation of cell culture skids is preferred.
- Demonstrated ability to work and communicate collaboratively with others.
- 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.
- Knowledge of quality systems and cGMP operations is Preferred.
- Ability to safely lift at least 25 pounds.
- Good interpersonal skills and attention to detail.
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.