Job Description

Description

Summary​
  • Lead and oversee technology transfer activities for processes and/or QC analytical methods, including transfer between development, manufacturing, and external partner laboratories.
  • Define and execute transfer strategies, protocols, acceptance criteria, and readiness assessments to ensure successful implementation at receiving sites.
  • Serve as the primary technical point of contact for external partners, including CDMOs and contract laboratories, ensuring alignment on technical expectations, timelines, and quality standards.
  • Provide scientific oversight of outsourced activities, including issue resolution, deviation investigations and performance monitoring.
  • Support preparation, review, and defense of CMC‑related regulatory documentation associated with tech transfer, outsourcing, and lifecycle changes.
  • Provide scientific input to regulatory interactions, including responses to health authority questions relate...

    • Ready to Apply?

    Take the next step in your AI career. Submit your application to CSL today.

    Submit Application