Description

Manage end-to-end method transfers and validations for late-phase and commercial cell therapy products in a regulated GMP environment.

Lead method transfer and validation activities at internal sites and contract test labs. Develop project plans, timelines, and risk mitigation strategies using PM software. Coordinate cross-functional teams to ensure deliverables meet project schedules. Support change controls and act as the Quality liaison during QC investigations.

Responsibilities

• Own the drug product method lifecycle across a multi-product portfolio.
• Lead method transfer and validation activities at internal sites and contract test labs.
• Develop project plans, timelines, and risk mitigation strategies.
• Coordinate cross-functional teams to ensure deliverables meet project schedules.
• Support change controls and act as the Quality liaison during QC investigations.

Required Skills

• BS or MS in a relevant scientific discipline.
• 5+ years in regulated GMP biopharmaceutical, cellular, or gene therapy environments.
• Deep knowledge of analytical method lifecycle: assay qualification, transfer, validation, and maintenance.
• Experience implementing release methods in commercial QC facilities.
• Proficiency with PM software for tracking progress, action logs, and risk logs.
• Strong technical writing skills for QC lifecycle management procedures.
• Working knowledge of FDA, EMA, ICH, USP, and EP guidelines.
• Experience applying cGMP regulations within Quality Control.

Preferred Skills

• Experience managing external contract testing.

Key Skills

Education

Any Gradute