Position Summary

The Associate Director, Manufacturing will be responsible for Odonate's drug substance and/or drug product contract manufacturing. Leveraging commercialization expertise, this individual will lead tech transfers, process development and manufacturing operations to support the Phase 3 study. The Associate Director, Manufacturing will serve as drug substance Subject Matter Expert and author drug substance sections for regulatory documents.

Essential Duties and Responsibilities

  • Manage Odonate drug substance CMOs, including PIP responsibilities. Ensure uninterrupted API supply that is manufactured within GMP compliance, CMC regulatory filings and Odonate standards
  • Manage manufacturing operations, including tech transfer, scheduling, logistics, batch record review, change controls, QA investigations, review of validation protocols and reports and development of specifications
  • Oversee late-stage development activities, including DOE and PAR studies, registration and validation manufacturing
  • Author drug substance sections for regulatory documents, including IND amendments, NDAs and MAAs
  • Generate budgets, technology packages and RFPs
  • Negotiate MSAs, WOs and SOWs

Qualifications

  • Minimum 10 years of progressive experience in a manufacturing or supply chain organization within the pharmaceutical industry required
  • Experience in launching and commercializing new products, including both NDAs and ex-European marketing applications a plus
  • Deep knowledge of US and European Good Manufacturing Practices (cGMP) required
  • Excellent strategic thinking skills with demonstrated ability to successfully create and implement both short and long range plans to support the business strategy
  • A willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment
  • Ability to organize and assimilate data/information to prepare contingency plans and future strategies
  • Excellent strategic thinking skills, with demonstrated ability to successfully create and implement both short-term and long-term plans to support the department and business needs
  • Ability to effectively engage and influence internal and external leaders, solicit information, persuade others and shape outcomes
  • Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences
  • Domestic and international travel up to 25% required
 

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