Sr. Scientist, Upstream Process Development

Location
South San Francisco, CA
Posted
Jun 02, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract

About Us:

Vaxart is a clinical-stage company developing tablet vaccines based on its proprietary oral vaccine platform. The lead programs are prophylactic oral vaccines for COVID, seasonal influenza, RSV, and norovirus, as well as a therapeutic vaccine for HPV types 16 and 18. Vaxart vaccines are convenient room temperature-stable tablets that are easy to administer, and that eliminates the risk of needle-stick injury and medical waste associated with injectable vaccines. Vaxart is listed on the NASDAQ exchange under ticker symbol VXRT.

Summary:

The Sr. Scientist is responsible for designing, executing, and reporting experimental activities in the Upstream

Development laboratory with a focus on developing a next generation Ad5 production process that includes a lyophilized drug substance. The position requires a talented Scientist/Sr. 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.

Responsibilities:

  • 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. Establish and foster relationships with contract manufacturing organizations.
  • Provides Subject Matter Expertise and leadership to the Drug Product unit.

Requirements:

  • BS or MS in Biological Sciences, Bioengineering, Biochemistry, or other closely related fields.
  • Ph.D. plus 5 years’ relevant experience.
  • 10 years’ relevant industry experience.
  • At least 2 years of prior management experience.
  • Experience in Mammalian cell culture in a GMP environment.
  • Familiarity in production and purification of viral products.
  • Strong communication and teamwork skills.
  • Ability to gain cooperation of others.
  • Strong experience in general or direct supervision with exempt employees and/or skilled non-exempt employees.
  • Knowledge of QC issues.
  • Expert in 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.