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Director for Drug Substance Commercialization - Remote

Posted 2 weeks ago

Overview

The Director for Drug Substance (DS) Commercialization of Conjugation will lead and facilitate launch readiness and commercial supply of glycoconjugate drug substances, including the polysaccharide activation, conjugation, and associated raw materials.

In Short

  • Lead and facilitate launch readiness for glycoconjugate drug substances.
  • Focus on technical launch planning and execution.
  • Coordinate cross-functional efforts for regulatory filings and facility readiness.
  • Communicate scientific and commercial rationale for critical raw material processes.
  • Ensure on-time execution and planning for commercial lifecycle management.
  • Collaborate on overall program strategy.
  • Lead technical and process support for commercial manufacturing.
  • Conduct process characterization experiments in support of validation.
  • Investigate process-related manufacturing issues.
  • Ensure continuous improvement in process robustness.

Requirements

  • Experience in drug substance commercialization.
  • Strong understanding of glycoconjugate processes.
  • Leadership skills in cross-functional teams.
  • Familiarity with regulatory requirements.
  • Excellent communication skills.
  • Ability to manage complex projects.
  • Knowledge of manufacturing science and technology.
  • Experience with process improvement methodologies.
  • Strong problem-solving skills.
  • Commitment to patient outcomes and enterprise value creation.

Benefits

  • Opportunity to lead in vaccine innovation.
  • Collaborative and inclusive work environment.
  • Focus on professional growth and development.
  • Engagement in meaningful work that impacts public health.
  • Competitive salary and benefits package.

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