Consultant

Description:

A confidential gene therapy company in Texas is preparing for its first Process Performance Qualification (PPQ) campaign and is looking for an experienced consultant to lead key strategy and execution activities.

The team has completed a raw material risk-ranking exercise, qualified multiple critical inputs, and onboarded external testing labs, but with most team members going through PPQ for the first time, they need a seasoned hand to guide the process.

Key Responsibilities:

• Lead cross-functional planning and execution of PPQ readiness strategy
• Ensure raw material qualification, documentation, and traceability are PPQ-compliant
• Advise on risk mitigation approaches for materials and methods
• Support gap assessments and inspection readiness activities
• Provide mentorship and structure for a team new to PPQ
• Collaborate with QA, QC, Supply Chain, and Process Development to align CMC deliverables