Description

Lead and supervise upstream, downstream, and cell/virus banking teams in a GMP manufacturing facility. Oversee daily operations, ensure compliance with cGMPs, and drive continuous improvement to support gene therapy production.

Requirements

• Prior leadership experience in GMP manufacturing facility
• Experience in (bio)-manufacturing unit operations
• Hands-on experience writing and reviewing documentation
• Ability to adhere to regulatory policies (EMA, FDA)
• Bachelor's degree in Life Sciences or Engineering

Responsibilities

• Supervise, train, and mentor upstream, downstream, drug product, and banking teams
• Primary contact for troubleshooting and issue resolution
• Oversee routine and critical operations including commissioning and validation
• Ensure documentation meets good documentation practices
• Respond to CMS alarms on-call including off-hours and weekends