Associate Director/Director, Upstream Process Development

About Us:

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 Associate Director/Director of Upstream Process Development to join our growing South San Francisco team!

Summary:

The Head of Upstream Process Development is responsible for designing, executing, and reporting experimental activities in cell culture process development laboratory with a focus on developing a next generation Ad5 production process. Will be asked to troubleshoot existing platforms and assist in manufacturing operations as well. Will communicate progress and results to senior management via technical reports and or presentations. Must be able to work closely with Downstream and Formulation Development units as well as Manufacturing organizations to define unit operations that fit manufacturing constraints and corporate timelines. The successful candidate will be expected to work with in-house and partnering development and manufacturing organizations in tech-transfer and manufacturing support roles. Will also be asked to train and mentor junior scientists, to take a leading role in designing and organizing the Cell Culture Process Development laboratory, and to establish a culture of general compliance, safe operations, and proper documentation and communication of results. Familiarity with viral vector production would be a significant asset.

Responsibilities:

• Manages process development staff and contract service providers in upstream drug substance process development activities and technology transfer to Manufacturing. Performs, instructs, and directs others in mammalian cell culture and virus production. Will assist development of robust and cost-effective commercial scale production processes.
• Writes and/or reviews protocols, development reports, batch records, standard operating procedures, and other technical reports in support of manufacturing and process tech transfer. Assures that results are properly archived and communicated.
• Responsible for understanding and applying data generated from experiments and literature used to modify/optimize process parameters. Evaluates new technology and procedures.
• Manages and trains staff as appropriate in laboratory activities. Assures that training and compliance records for themselves and staff are up to date and appropriate. Assures that all safety procedures are followed.
• Proactively communicates with internal and external stakeholders. Establish and foster relationships with contract manufacturing organizations.

Requirements:

• BS or MS in Bioengineering, Biochemistry, and other appropriate fields and 8+ years of relevant industry experience OR a Ph.D. in Bioengineering, Biochemistry, or closely related field and 5+ years of relevant experience.
• At least 2 years of prior management experience.
• Strong Experience Mammalian cell culture in a GMP environment.
• Experience with stirred-tank bioreactor operations and control
• Familiarity with Production and purification of viral products.
• Strong communication and teamwork skills.
• Ability to gain cooperation of others.
• Experience in general or direct supervision to exempt employees and/or skilled non-exempt employees.
• Experience and knowledge of QC issues.
• Expertise Sterile techniques and hazardous/infectious material handling.

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.