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