Kevin J. Bittorf, PhD, MBA, PEng
Kevin J. Bittorf is a seasoned executive and consultant specializing in pharmaceutical development, technical innovation, and regulatory strategy. With extensive experience in GMP compliance, business development, contract manufacturing, and long-term strategy, Kevin collaborates with CEOs and executives to drive pharmaceutical advancements by evaluating strategic approaches, securing regulatory approvals, and implementing emerging technologies that improve the drug development lifecycle.
As the Founder of SCxCMC, Kevin provides expert consulting to small and medium-sized pharmaceutical and biotechnology companies, focusing on pharmaceutical development, process chemistry, formulation, regulatory affairs, quality assurance, supply chain, and packaging. His work ensures that companies efficiently navigate CMC challenges, optimize manufacturing strategies, and successfully transition from early development to commercialization.