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 an MSAT Engineer, Downstream to join our growing South San Francisco team!
The Engineer II/III of Manufacturing Science and Technology (MSAT) will be responsible for technical manufacturing support focusing on the downstream operations in accordance with current good manufacturing practices (cGMP) for Vaxart’s Ph I/III GMP manufacturing at CMO’s. The Engineer II/III initiates MS&T activities and provides leadership for activities to ensure robust and reliable production processes are established through a thorough technology transfer process to enable each site to succeed in product delivery. The MS&T Engineer partners with Process Development, EHS, Quality, and Manufacturing groups to ensure compliance and collaboration. This position will also interface with external CMO’s, providing expertise and process guidance.
- Provides technical process leadership to manufacturing to support Ph I through Ph III cGMP manufacturing. Lead tech transfer efforts for internal and external manufacturing and support activities through process validation.
- Supports manufacturing investigations as required with batch record review, data analysis of results, experimental investigation planning, and writing/review of technical reports. Must be able to work closely with development and Quality SME’s to support investigations. Manage investigations and address deviations and implement change controls
- Recommends equipment design and materials assessment
- Routinely troubleshoots operational issues for process-related operations
- Maintains and manages data collection. Performs statistical analysis and recommends data-driven process improvements
- Generates protocols and reports for any process related studies
- Performs risk assessments including hazard and operability studies
- Manages technology transfer from Development to internal and external manufacturing sites ensuring effective information flow, timeline execution, issue resolution, training, and documentation in accordance with governing tech transfer quality system requirements while leveraging robust risk management practices.
- Be the primary point of contact for at least one CMO and be the person-in-plan (PiP) for critical manufacturing activities.
- Works with Manufacturing staff for the preparation and review of necessary technical documentation (SOP’s, BPR’s, specifications, etc.).
- Trains manufacturing staff on new and improved processes
- Keep current on regulatory and quality requirements and follow Environment, Health & Safety policies.
- B.S. or M.S. in Biological Sciences, Pharmaceutics or Engineering
- Minimum of 8 years of experience in the biopharmaceutical industry.
- Strong downstream technical processing expertise
- Deep technical, operational, and hands-on equipment knowledge related to all downstream operations such as chromatography, defiltration, etc.
- Minimum of 5 years of experience in the manufacture of bulk drug substances based on cell culture production; virus production preferred.
- 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 being responsible for the 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 function in a rapidly changing environment & handle multiple priorities.
- A flexible work schedule is required.
- Ability to safely lift at least 25 pounds.
- Willing to travel to external CMO's, as needed.
Vaxart has implemented a mandatory COVID-19 vaccination policy which requires our employees to be fully vaccinated against COVID as a condition of employment. Vaxart will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. Vaxart prioritizes sound science and available facts to best ensure the ongoing safety of our employees and the community.
Vaxart offers team members a competitive compensation and benefits package, including a robust health plan, 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, and 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.