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About the role

  • Director overseeing commercial CMC programs for Telix, a radiopharmaceutical company developing targeted radiation products. Managing manufacturing, CDMO partnerships, supply chain, and clinical-to-commercial execution.

Responsibilities

  • Develop manufacturing and operational plans for commercial and late-stage clinical assets
  • Oversee a team of CMC program leads
  • Ensure execution of CMC strategies through cross-functional collaboration with internal and external partners
  • Coordinate and deliver CMC activities for Precision Medicine Diagnostics and Therapeutics programs
  • Establish global production, supply chain, logistics, and distribution supporting clinical-to-commercial progression
  • Partner with contract manufacturers and serve as liaison and escalation point for the External Contract Manufacturer network
  • Oversee manufacturing, quality, and product development from mid-stage clinical through commercial manufacturing
  • Manage contracts, budgets, cost savings, and capacity management
  • Sustain ECM strategy with Manufacturing Operations, Biologics, Radiochemistry, CMC Programs, Supply Chain, and Procurement
  • Coordinate internal and external communications and resolve business issues
  • Lead development and performance management of Commercial CMC Program Leads
  • Lead supplier performance business reviews
  • Create and populate ECM metrics scorecards and dashboards
  • Manage commercial manufacturing budgets and continuous improvement

Requirements

  • BA or BS degree in Engineering, Biology, Chemistry, Business or other relevant field
  • 10+ years combined experience in cGMP Manufacturing, Contract Manufacturing, Business Development, or Quality
  • Experience managing cross-functional teams, external partners, and CDMOs required
  • Experience managing cross-functional teams and International Contract Manufacturing Organizations
  • Ability to travel approximately 30% - both domestically and internationally
  • Direct experience in Sterile Injectable Filling and Lyophilization of Drug Product/Substances supporting both pre-commercial and commercial products preferred
  • Direct experience in Secondary Packaging of Parenteral drugs preferred
  • Direct experience in complex formulations of bulk drug substances and biologic drug substance manufacturing preferred
  • Strong communication, collaboration, adaptability, ethical behavior, and continuous learning capabilities

Benefits

  • Annual performance-based bonuses
  • Equity-based incentive program
  • Generous vacation
  • Paid wellness days
  • Support for learning and development
  • Competitive salaries

Job title

Job type

Full Time

Experience level

Lead

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

RemoteUnited States

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