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Director, Global Drug Substance Commercialization, Polysaccharide - Remote

Posted 17 weeks ago
All others
Full Time
CA, USA

Overview

The Director for Drug Substance (DS) Commercialization of Polysaccharides will lead and facilitate launch readiness and commercial supply of the polysaccharides used in glycoconjugate vaccines, focusing on technical launch planning and execution.

In Short

  • Lead and facilitate launch readiness for polysaccharides in glycoconjugate vaccines.
  • Coordinate cross-functional efforts for regulatory filings and facility readiness.
  • Provide leadership for scientific and commercial rationale communication.
  • Collaborate on overall program strategy and critical raw material strategy.
  • Continuously improve process robustness and understanding.
  • Support technical services and manufacturing network.
  • Engage in technical reviewing and authoring of regulatory filings.
  • Build a strong team focused on polysaccharide manufacturing processes.
  • Travel required: 10-30%.
  • Contribute to effective delivery of life-enhancing therapies.

Requirements

  • Degree in Chemical/Biochemical Engineering, Chemistry, or related discipline.
  • 10+ years of relevant experience for Ph.D., 12+ years for M.S./M.A., or 16+ years for B.S./B.A.
  • Extensive experience in biologic production processes.
  • Leadership experience in MSAT or Process Development.
  • Excellent organization and strategic planning skills.
  • Highly skilled in verbal and written communication.
  • Proactive in recognizing needs and challenges.
  • Able to analyze data to support decisions.
  • Creative approach to developing innovative ideas.

Benefits

  • Opportunity to lead in a clinical-stage vaccine innovation company.
  • Collaborative and inclusive work environment.
  • Engagement in meaningful work to protect humankind.
  • Professional growth and development opportunities.
  • Competitive compensation and benefits package.
Vaxcyte logo

Vaxcyte

Vaxcyte is a clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines aimed at protecting humankind from serious bacterial diseases. With a focus on eradicating or treating infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella, Vaxcyte is committed to addressing the significant health consequences of these conditions. The company operates under four core values: rethinking convention, aiming high, leading with heart, and modeling excellence, which guide their collaborative and innovative approach to vaccine development. Vaxcyte is positioned for success in the biotechnology sector, emphasizing quality assurance and regulatory compliance in its operations.

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