🛠 Tech Stack

💼 About This Role

You'll be responsible for leading lot disposition activities for gene therapy products at a clinical-stage biotech. You'll ensure all manufacturing and testing data complies with cGMP and regulatory requirements, working closely with CMOs and internal teams.

🎯 What You'll Do

• Review batch records and analytical data for lot disposition.
• Oversee lot disposition processes for internal and CMO materials.
• Evaluate CMO/CTL data for compliance with specifications.
• Support internal and external audits related to lot disposition.

📋 Requirements

• Bachelor's degree in a scientific discipline.
• 5 years QA experience in pharma/biotech.
• cGMP and regulatory knowledge.
• Experience reviewing batch records and quality docs.

✨ Nice to Have

• Experience with CMOs and CTLs.
• Proficiency in MasterControl or similar QMS.