Associate Director, Drug Substance Development

Kardigan is looking for a Associate Director/Director to join the Drug Substance team within the Technical Operations department. The Associate Director will be responsible for the implementation of oligonucleotide and small molecule manufacturing technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (global guidance documents, process control strategies, process risk assessments, etc), inspection readiness, and technical regulatory submissions.

Requirements

• Lead process and technology transfers, change management, and technical process support clinical and commercial Oligonucleotide and small molecule products.
• Owner of process control strategies including process risk assessments and process validation.
• Comprehensive data analyses using historical process experience and characterization studies to identify trends in process performance and drive changes in the process control strategy and risk assessments
• Lead production related investigations, ensuring compliance with internal standards and regulatory requirements.
• Own process validation (PV) reports including process monitoring of manufacturing processes to understand process capability and performance drift over time.
• Provide necessary technical analysis to support impact assessments and investigations.
• Develop, execute and implement manufacturing process improvement activities in accordance with the overall life cycle plan for the product
• Share operational and process learnings with the rest of the manufacturing network