Downstream Manufacturing Associate II
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 Downstream Manufacturing Associate II to join our growing South San Francisco team!
* Please note that we cannot sponsor Visas at this time.
The Manufacturing Associate II will follow current Good Manufacturing Practices (cGMPs) and adhere to Vaxart Quality systems in the execution of Drug Substance Manufacturing Operations. The Manufacturing Associate II will execute process activities across a variety of manufacturing production activities such as filtration operations, Media exchange, chromatography, chromatography column packing and testing, tangential flow filtration, buffer preparation and aseptic operations.
- Performs Downstream and Buffer preparation activities as part of the Drug Substance process under a cGMP compliance for successful batch execution and lot release.
- Understanding of Cell thaw, Cell seed trains, Cell Passage, Bioreactor inoculation, Monitoring of Cell growth, but not required.
- Cross-train and support Upstream activities as needed.
- Trains junior associates in downstream operations to be technically qualified and well trained in cGMP manufacturing activities.
- Develops, implements and updates manufacturing Standard Operating Procedures (SOPs), batch records (BRs), material specifications and other documentation needed for cGMP compliance.
- Supports deviation investigations and reports so they are written accurately and appropriately as they occur and adhering to company’s Quality systems.
- Supports the implementation of new technology and procedures into manufacturing as needed.
- Other duties as assigned.
- B.S. in Biological Sciences, Pharmaceutics, Engineering or equivalent work experience.
- Minimum of 1-5 years of experience in the biopharmaceutical industry.
- Minimum of 3 years of experience in the manufacture of bulk drug substance based on cell culture production.
- Minimum of 1–5 years’ experience with cell culture operation of bioreactors preferred.
- Minimum of 1- year experience with chromatography and TFF systems is preferred.
- Experience working in a GMP environment executing manufacturing operations.
- Experience executing Chromatography operations, Diafiltration (DF) and ultrafiltration (UF) activities as part of tangential flow filtration (TFF) operations using single use technology (SUT).
- Experience with the set-up and operation of single-use chromatography and TFF skids is preferred.
- Experience with chromatography column packing and testing preferred.
- Experience with buffer preparation.
- Experience with cell thaw, seed trains, cell growth passage, Bioreactor inoculation, media exchange, aseptic technique, and filtration operations.
- Attention to detail adhering to cGMP practices, following Standard Operation procedures, and adhering to Quality systems.
- Demonstrated ability to work and communicate collaboratively and effectively with others.
- Must have strong critical thinking skills, initiative, and integrity.
- 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 manufacturing operations and other tasks.
- Ability to problem solve, think critically, and troubleshoot while working independently.
- Familiarity and knowledge of quality systems and cGMP operations.
- Ability to safely lift 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.