Karim Dudum is a biotech consultant at SynerG, where he supports advanced therapy developers in translating complex science into compliant, reliable GMP operations that protect both product quality and patient safety.

Karim brings a multidisciplinary background spanning product development, manufacturing operations, and large-scale capital projects. Prior to consulting, he spent time as a development engineer working on a tissue-engineered combination product, where he led cross-functional efforts across product and process development, product lifecycle management, and verification and validation — taking multiple products from concept and feasibility through clinical release. He later transitioned into life sciences consulting, supporting biopharmaceutical organizations with facility start-up, validation programs, CQV strategy, and technical operations for complex GMP environments.

He holds a bachelor’s degree in Biomedical Engineering, a master’s degree in Regenerative Medicine and Stem Cell Biology, and an MBA. Karim is particularly passionate about helping emerging ATMP companies build phase-appropriate systems that enable speed without sacrificing compliance — ensuring innovative therapies can reach patients safely and efficiently.