Head of Manufacturing

Location
South San Francisco, CA
Posted
Jun 02, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
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 Head of Manufacturing to join our growing South San Francisco team! This position can also be remote for the right person.

Summary:

The Head of Manufacturing (HoM) is responsible for developing a strategic vision for manufacturing of drug substance and drug product at Vaxart. The HoM will oversee internal and external manufacturing via CDMOs for clinical trial material, scale-up and production of material for rapid commercialization of Vaxart’s COVID vaccine. Additionally, the HoM will develop plans and lead the manufacturing of Vaxart’s pipeline vaccines. The HoM works with internal and external resources to ensure manufacturing schedules meet clinical drug supply requirements and corporate objectives. The HoM along with Quality will ensure that all GMP operations maintain a state of cGMP compliance.

The HoM is responsible for managing all aspects of the operations pertaining to internal and external GMP facilities, including engineering, automation, IT, manufacturing, logistics, EHS, and business excellence. The HoM will lead a group of operators and engineers to perform and oversee production and validation activities working in cross-functional teams. The HoM will communicate plans and progress to the Vaxart executive team, Quality Assurance, Project Management, and other organization stakeholders.

Responsibilities:

Leadership and strategy

  • Participate in defining strategic manufacturing goals and objectives.
  • Create the vision, establish the strategic manufacturing goals and budgets, make policy and infrastructure decisions that ensure linkage to the business strategy.
  • Develop a strategy for clinical through commercial manufacturing using internal manufacturing resources as well as CDMOs.
  • Lead cultural and organizational change, implement operational excellence and lean manufacturing for continuous improvement of competitiveness and financial performance.

Operations and management

  • Lead the design of facilities and equipment and work with Development for the optimization of existing manufacturing processes to deliver FDA compliant production capacity on time and within budget.
  • Implement the appropriate team and departmental structure and establish the required processes and communications to enable the department to effectively deliver on all commitments.
  • Build strong relationships with CDMOs for accelerated advancement of our COVID vaccine as well as pipeline programs.
  • Lead and facilitate the implementation of new systems, software, policies and procedures.
  • Responsible for ensuring consistent product delivery.
  • Responsible for the outgoing quality, safety and efficacy of all finished product, compliance with all applicable specifications, SOP’s, FDA regulations and cGMP’s.
  • Responsible for cGMP compliance by defining, implementing and maintaining appropriate SOP’s and training.
  • Responsible for facility audits by regulatory agencies and funding partners
  • Manage external contractors and consultants to successfully achieve production and validation goals.
  • Responsible for talent management (recruitment, development and retention) in manufacturing department.

Scientific Excellence

  • Provide engineering leadership in the development and implementation of new equipment, processes and approaches that support new and custom product development and sustain and enhance existing products.
  • Lead the effort of process definition, improvement and troubleshooting by appropriate use of manufacturing resources and by influencing other groups such as Process Development, Quality Control, and Quality Assurance.

Requirements:

  • B.S., M.S. or Ph.D. in Biological Sciences, Pharmaceutics or Engineering.
  • 15+ years of leadership and managerial experience directly leading people in a multi-tiered organization including experience leading teams, projects, and programs, and directing the allocation of resources in operations environment.
  • 15+ years’ experience with in-house pharmaceutical manufacturing as well as managing external Contract Manufacturing organizations.
  • Demonstrated ability to work and communicate collaboratively with other internal and external staff.
  • Strong critical thinking skills, initiative, integrity, and strong interpersonal and leadership skills.
  • The ability to communicate clearly and precisely, both orally and in writing, is essential.
  • Extensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development with prior experience through commercialization.

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.