Associate Director of Manufacturing (Onsite/Remote)

Location
Remote
Salary
DOE
Posted
Jul 06, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

Position Summary

The Associate Director of Manufacturing will be responsible for Odonate drug substance 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 of 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

  • PhD degree in Life Sciences discipline required
  • 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