Senior Director, Drug Substance Manufacturing - Waltham

Only for registered members Waltham, United States

20 hours ago

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Job summary

The Senior Director, Drug Substance Manufacturing is responsible for leading GMP drug substance manufacturing, process performance qualification (PPQ), ensuring commercial supply, and overseeing all CMC activities related to Fab-oligonucleotide conjugates (drug substance).+
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Responsibilities

  • Responsible for bioconjugation activities including validation, characterization, scale-up, clinical and commercial manufacturing.
  • Establish and manage contracts, supply agreements and CDMOs
  • Overssee suppliers and vendors involved in materials planning, inventory control , logistics , distribution to ensure that batch manufacturing is completed on a timely basis

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