Associate Director/Director, Formulation
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 seeking an Associate Director/Director of Formulation to join our growing South San Francisco team!
The Head of Formulation is responsible for designing, executing, and reporting experimental activities in Formulation Process Development laboratory with a focus on developing a next generation Ad5 production process that includes a lyophilized drug substance. The position requires a talented senior-level scientist to lead a new group in Formulation Development. The successful candidate will be asked to troubleshoot existing platforms and to develop new formulations to increase product stability and yield, decrease process time, and improve the robustness of the formulation. Will communicate progress and results to senior management via technical reports and or presentations. Must be able to work closely with Downstream and the Manufacturing units to define operations that fit manufacturing constraints and corporate timelines. Will also be asked to train and mentor junior scientists, to take a leading role in designing and organizing the Formulation 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.
- Manages formulation process development staff and contract service providers in the design, execution, and interpretation of experiments. Will be expected to lead in the construction of a formulation development laboratory. Will lead the development of robust and cost-effective commercial scale formulation that is consistent with manufacturing capabilities and corporate timelines, including lyophilization cycle improvement.
- 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 and establish and foster relationships with contract manufacturing organizations.
- Provides Subject Matter Expertise and leadership to the Drug Product unit.
- Degree in Biological Sciences, Bioengineering, Biochemistry, or other appropriate fields.
- B.S. or M.S. 10 years of relevant industry experience OR Ph.D. and 5 years of relevant experience.
- A minimum of 2 years of leadership and management experience, directly leading teams.
- Demonstrated ability to communicate collaboratively and must have great teamwork skills.
- Ability to gain cooperation of others.
- Familiarity with production and purification of viral products.
- Demonstrated ability to lead and directly supervise employees at all level.
- Knowledge of QC issues.
- Expert with sterile techniques and hazardous/infectious material handling.
- Experience with mammalian cell culture in a GMP environment.
Vaxart offers team members a competitive compensation and benefits package, including a bonus program, stock options, 401(k) 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.