Director, Project Management (CMC)

Location
South San Francisco, CA
Posted
May 28, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

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 a Director, Project Management (CMC) to join our growing South San Francisco team!

* Please note that we cannot sponsor Visas at this time.

Summary:

The Director of Project Management, CMC has a strong technical drug product development background to support its Chemistry, Manufacturing, and Controls (CMC) team leads in coordinating activities related to the development, clinical, launch and commercial manufacturing of drug substances and drug products in its portfolio. The successful candidate will work closely with the CMC leads and others in the Development group to: provide project management support for ongoing development programs as well as planning of launch and commercial activities; coordination of Module 3 regulatory filing activities; management of documentation; tracking of agreements and contracts as well as relevant technical documents and support of meeting scheduling. As a member of the Technical Operations team, the Director will ensure that CMC project management works seamlessly with Vaxart’s program management group and closely with Quality, Regulatory Affairs, CMC leads and others on the project team, as well as key external parties.

Responsibilities:

  • Facilitate development and oversee execution of CMC and Technical Operations’ plans, including planning and execution of development, validation and launch through commercial manufacturing activities. Work closely with Vaxart program management group, project and launch teams to insure seamless communication throughout the organization.
    • Integrate detailed execution and short and long-term development plans across the various CMC and Technical Operations areas, including Process, Analytical and Formulation Development, Drug Substance and Product Manufacturing, Supply Chain, Logistics for a portfolio of projects.
    • Anticipate issues (technical, business, regulatory) and recommends mitigation for emerging risks.
    • Schedule and coordinate internal Tech Ops team meetings, agendas and minutes.
    • Prepare plans and timelines based on input from CMC and Tech Ops teams.
    • Creates gantt charts using Microsoft project software; Tracks tasks and completion status.
    • Ensure alignment with cross functional team project managers; Provide clear directions to meet expectations of all stakeholders.
  • Manage CMC-related activities related to regulatory filings, long range planning, purchase request, invoices, contracts, agreements, technical reports, meeting scheduling.

Requirements:

  • BS with 10-15 years’ experience, or advanced degree with 8+ years’ experience in Pharmaceutical Development or Technical Operations environment. Strong working knowledge of regulatory requirements for product registration and commercial manufacturing. Prior experience with launch preparedness and planning.
  • A minimum of 2 years’ supervisory experience.
  • Strong track record of success in drug development and in understanding cross-functional interdependencies.
  • Outstanding interpersonal skills and excellent oral and written communication skills.
  • Outstanding organizational skills. Detail oriented with the proven ability to excel in a matrix environment. Strong track record of enjoying the details without losing sight of the larger goals.
  • Ability to multi-task and handle multiple projects simultaneously.
  • Fluent with Microsoft project.
  • Proven ability to effectively participate on multi-disciplinary project teams.
  • Organizationally savvy.
  • Strong initiative and desire to work in a fast paced, team-oriented dynamic environment.
  • Able to thrive independently in a fast-paced environment and working with limited support is required.
  • Team-oriented, pro-active, and able to reinforce Vaxart Culture and drive change where needed.

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.