CMC Process Validation Scientist

Position Overview

We are seeking an experienced Senior CMC Process Validation Scientist with a strong background in advanced therapy products, particularly viral vector-based gene therapies. This role will play a critical part in process validation and compliance activities, partnering with cross-functional teams to support manufacturing readiness and regulatory requirements.

Key Responsibilities

• Partner closely with CMC teams and cross-functional stakeholders to ensure alignment across development, manufacturing, and regulatory functions.
• Navigate complex manufacturing and regulatory requirements for advanced therapy medicinal products (ATMPs), with a focus on gene therapy.
• Develop, implement, and execute PPQ (Process Performance Qualification) strategies for viral vector-based products.
• Lead and support process characterization, risk assessments, and control strategy development.
• Collaborate with QA and manufacturing teams to ensure GMP compliance during all validation activities.

Qualifications

• Proven experience in CMC process validation within the advanced therapy or gene therapy field.
• Hands-on expertise in PPQ, process characterization, and control strategy development.
• Strong understanding of GMP requirements for validation activities.
• Ability to operate effectively in a cross-functional, fast-paced environment.