Upstream Manufacturing Lead
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 Upstream Manufacturing Lead to join our growing South San Francisco team!
The Lead of Upstream Manufacturing is responsible for leading the upstream activities of vaccine drug substance manufacturing operations in Vaxart facilities. This person develops the upstream schedules and contributes to the development of departmental objectives. In meeting these goals, the Upstream Lead will ensure that the upstream activities are completed in a GMP compliant manner. The lead manages day-day upstream operations with a hands-on approach to all aspects of upstream activities. The Upstream Lead is expected to be the internal expert of upstream activities using state of the art single-use systems. Manages upstream timelines and daily operations as required to meet accelerated COVID19 and other vaccine manufacturing schedules or resolve problems. Communicates progress to the manufacturing manager, Quality Assurance, Project Management, and other organization stakeholders as required.
- Leads and coordinate the upstream manufacturing staff in drug substance production.
- Able to demonstrate proficiency as Subject Matter Expert (SME) for operations.
- Performs, instructs, and directs others in upstream production of drug substance.
- Supports Downstream, Buffer Preparation and Drug Product Manufacturing Operations as needed for successful batch execution and lot release.
- Defines implements and optimizes Upstream Manufacturing Operations to successfully achieve production timelines.
- Train staff in Upstream Operations and other manufacturing activities as needed.
- Support 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, owns, and completes deviation reports (DRs) or discrepancies per Vaxart Quality systems in a timely manner.
- Responsible for understanding and applying process transfer and process improvements from process development (PD) to manufacturing.
- Implements new technology and procedures into upstream and other manufacturing areas when needed.
- Provide reasoned and timely input to Management and others in developing a structure and vision for manufacturing operations.
- Contribute to facilities design and existing facility modifications, as necessary, as part of facility design projects.
- Provide a safe working environment for the manufacturing and other teams.
- Actively coaches and mentor manufacturing associates.
- Serves as a management team back-up when needed.
- Perform and execute other duties as assigned by the management team.
- Demonstrates knowledge and proficiency of manufacturing aseptic techniques and processing operations.
- B.S. in Biological Sciences, Pharmaceutics, Engineering, or equivalent work experience.
- Minimum of 8 years of experience in the biopharmaceutical industry.
- Minimum of 8 years of experience in the manufacture of bulk drug substance based on cell culture production.
- Experience with Single Use Technology (SUT).
- Experience in suspension of cell culture operations in shake flasks, incubators along with cell bank production.
- Proficiency in the execution of Cell thaw, cell seed trains, cell growth passages, Bioreactor inoculations, monitoring of cell growth, aseptic techniques.
- Ability to work and quickly adapt in a fast-paced environment.
- Demonstrates critical thinking to solve problems with limited guidance.
- Experience initiating and owning deviations (DRs), CAPAs and Change Controls.
- Significant experience and ability to lead the set-up and operation of single-use bioreactors (≥50L) and can be considered the in-house expert.
- Ability to work and communicate collaboratively and effectively with others.
- Ability to train associates in Upstream process activities and new procedures, as necessary.
- Must have strong critical thinking skills, self-initiative, integrity, and strong interpersonal, leadership and GMP compliance skills.
- Ability to lead day-to-day manufacturing process operations.
- Highly motivated, able to multi-task, strict attention to detail and open to be responsible for successful execution of production schedule and other 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 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.