The selected candidate will play a pivotal role within CatalYm, developing and executing the CMC strategy in accordance with CatalYms development programs by ensuring timely supply of all clinical trial material and product quality required for non-clinical and clinical development.
In this role the selected candidate will lead and develop the CMC and supply team and provide operational excellence to the development program team. The (Senior) VP CMC will report to the Sr. VP Product Development
 
Your responsibilities
 

• Developing and executing the technical development and manufacturing strategy for the visugromab program, ensuring all CMC-related activities within agreed timelines/milestones, budget, quality and commercially viable COGS are achieved
• Ensuring GMP-compliant technical development of drug substance and drug product, resulting in robust and high yielding (low COGS) processes and a well-characterized high-quality product
• Ensuring the manufacturing and release of drug substance and drug product for non-clinical and clinical activities according to the agreed timelines. Managing and monitoring the clinical supply chain and ensuring in-time availability of clinical trial material according to the program plan
• Managing external service partners CDMOs: Defining requirements and criteria, building strong relationships/partnerships with CDMOs, leading negotiations together with COO, coordinating and monitoring external technical development and manufacturing.
• Ensuring that the CMC and supply department is represented in the cross-functional program team and fully supports it achieving corporate goals