Upstream Manufacturing Associate I
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.
The Upstream Manufacturing Associate I will follow current Good manufacturing Practices (cGMPs) and adhere to Vaxart Quality systems in the execution of Drug Substance Manufacturing Operations. The Manufacturing Associate I 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 Upstream activities and contributes to the development of departmental objectives. In meeting these goals, the Upstream Manufacturing Associate I will ensure that the Upstream activities are completed in a GMP compliant manner. The Upstream Manufacturing Associate I is expected to support 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.
- Support deviation investigations as needed.
- Support implementation of new technology and procedures into upstream manufacturing.
- Other duties as assigned.
- B.S. in Biological Sciences, Pharmaceutics, Engineering, or equivalent work experience
- Minimum of 0-2 years of experience in the biopharmaceutical industry.
- Minimum of 0-2 years of experience in the manufacture of Bulk Drug Substance based on cell culture production.
- Good interpersonal skills and attention to detail.
- 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.
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.