Associate Director, Manufacturing Science and Technology - Drug Product

PTC Therapeutics seeks an Associate Director to provide technical and operational oversight of drug product manufacturing for small molecule programs at contract manufacturers. The role encompasses formulation support, technology transfer, process validation, regulatory interactions, and on-site production monitoring to ensure GMP and ICH compliance.

Responsibilities

• Serve as person-in-plant technical contact; troubleshoot manufacturing, equipment, and material issues
• Lead technology transfer, validation, and process improvement initiatives with manufacturing partners
• Coordinate manufacturing, packaging, and labeling activities; ensure regulatory and GMP compliance
• Collaborate on deviation investigations, root cause analyses, and corrective action plans
• Author and review CMC sections for regulatory submissions and manufacturing protocols

Requirements

• Bachelor's degree in chemical engineering or related scientific discipline
• Minimum 8 years progressive small molecule drug product formulation and manufacturing experience
• Minimum 3 years person-in-plant, technology transfer, and process validation experience
• Knowledge of oral solid and liquid dosage form development and manufacturing processes
• Demonstrated expertise with GMP, GCP, and ICH guidelines for clinical and commercial operations
• Experience with process validation and packaging validation regulatory requirements