Open Position:

Position Title: Director or VP, Quality & CMC Project Management
Location: New York, NY

Avenue Therapeutics is a development-stage pharmaceutical company. Our lead product candidate is intravenous (IV) tramadol. We are looking for a unique individual who can both lead the CMC project management team and serve as head of quality function.

Major Duties and Responsibilities:
Provides project management and leadership skills to support the CMC activities

  • Maintains and executes CMC Project plans, timelines, agendas, resourcing requirements
  • CMO quality management (assess, audit, monitor)
  • Develop, review and approve quality agreements
  • Review/approve of batch records, specifications, analytical methods and batch related data
  • Batch disposition including deviation assessment and compliance monitoring
  • Stability program development and monitoring
  • Support to submission and compliance for NDA
  • Implementation of phase appropriate quality systems and metrics
  • Compliance assessment and reporting to management
  • Review and approve process and product validation protocols
  • Due diligence assessment

Job and Level Requirements:

  • Degree in relevant scientific discipline.
  • 5 or more years of experience in project management
  • 10 or more years of experience in industry as a quality professional involved with clinical development and successful NDA submissions
  • Excellent interpersonal, organizational, negotiation and communication skills; team member that can work collaboratively with colleagues across all functions
  • Excellent analytical, presentation, and writing skills are required
  • Experience managing clinical/commercial quality activities thru CMO’s
  • Ability to travel as needed

If you’re interested in submitting an application to Avenue Therapeutics, please send your resume to