Vaxcyte
Vaxcyte
Vaxcyte is a clinical-stage vaccine biotechnology company developing vaccines against serious bacterial infections. Its pipeline includes broad-spectrum pneumococcal conjugate candidates VAX-31 and VAX-24, alongside earlier-stage programs for Group A Streptococcus and Shigella. The company combines synthetic chemistry with a cell-free protein synthesis platform licensed from Sutro Biopharma to produce complex protein antigens. Its research and development work focuses on preventing invasive disease and addressing the consequences of antibiotic resistance, particularly for vulnerable populations.

Director, Global Drug Substance Commercialization

Lead polysaccharide commercialization, launch readiness, and supply planning at Vaxcyte, a clinical-stage vaccine company. Coordinate technical, regulatory, manufacturing, and cross-functional delivery.

विवरण

  • Lead commercialization workstreams and prepare commercial supply of polysaccharides for glycoconjugate vaccines.
  • Plan and execute technical launch activities, including regulatory filings, facility readiness, and launch supplies.
  • Coordinate teams across Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering.
  • Turn commercialization strategy into execution plans and deliver key technical milestones.
  • Build technical capabilities and inform resource and staffing recommendations.
  • Strengthen process understanding and reliability by monitoring, trending, and optimizing operations.
  • Identify, communicate, and escalate technical and supply risks.
  • Oversee technology transfers, new technologies, internal and external manufacturing sites, and contract manufacturing organizations.
  • Lead process validation and comparability work.
  • Review and prepare regulatory filings, and respond to health authority questions.
  • Explain process performance and the scientific and commercial rationale for polysaccharide processes to internal and external stakeholders.
  • Lead assigned polysaccharide commercialization programs and technical workstreams.
  • Report to the Senior Director and Global Polysaccharide Commercialization Lead.
  • Travel 10–30%.

आवश्यकताएँ

  • Degree in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or a related field, with at least 10 years of relevant experience for a Ph.D., 12 years for an M.S./M.A., or 16 years for a B.S./B.A.
  • Extensive experience with biologic production processes, including bacterial fermentation, recovery, and purification at multiple operating scales.
  • Experience with polysaccharides and glycoconjugate vaccines is highly preferred.
  • Leadership experience in MSAT or Process Development, in supervisory and/or matrixed team roles.
  • Apply deep technical knowledge collaboratively to shape strategic plans and achieve shared goals.
  • Strong organization, problem-solving, and strategic planning skills.
  • Excellent verbal and written communication, including the ability to work effectively with people from diverse backgrounds and perspectives.
  • Recognize needs and challenges and put effective solutions in place.
  • Find and analyze data from varied sources to support decisions and align others with organizational strategy.
  • Bring an entrepreneurial, creative approach to developing new ideas.
  • Able to travel 10–30%.

लाभ

  • Comprehensive benefits package.
  • Equity component.

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