Michael Capaldi

Mike Capaldi is an accomplished biopharmaceutical leader with over 20 years of experience in Large Molecule Chemistry, Manufacturing, and Controls (CMC). As Scientific Director in Protein Therapeutics API Development at Johnson and Johnson, he leads multidisciplinary teams delivering biologics drug substance development across diverse modalities ─ from early-phase process design through clinical development, validation, and commercial approval. Mike has directed and coached high-performing teams of scientists and engineers, driving successful technology transfers, process optimization, intensification initiatives, and regulatory submissions that have secured approvals of multiple novel oncology therapeutics across global markets. His extensive experience spans downstream operations, strategic process optimization, regulatory submission strategy, and risk management ─ consistently achieving on-time, on-budget delivery with full compliance to international health authority requirements. A strong advocate for talent development and cross-functional collaboration, Mike pairs deep technical knowledge in protein purification and process validation with the leadership skills to navigate complex projects through clinical and commercial milestones. He holds a Master’s in Biology from Villanova University, with a focus on molecular and immunobiology, and a Bachelor’s in Biotechnology from Pennsylvania State University. Based in Malvern, PA, Mike enjoys sports, traveling, and outdoor activities with his family.