Pharmaceutical Materials, Testing and Regulatory Affairs, Chemistry Manufacturing and Controls

Dr. Quin Christensen has 20 years of experience in industry and academia, including 8 years in global regulatory affairs for pharmaceuticals. He has played a critical role in advancing regulatory strategies for diverse modalities, including biologics, gene therapies, and small molecules. His combined expertise in scientific research and regulatory affairs makes him a valuable asset in pharmaceutical development, ensuring compliance, conducting due diligence, and facilitating successful product approvals.

Dr. Christensen has led end-to-end CMC regulatory planning for both early- and late-stage clinical programs, contributing to successful IND, BLA, NDA, and MAA submissions. He has managed regulatory interactions with global health authorities, including the FDA and EMA, to ensure compliance and accelerate product development. His expertise extends to lifecycle management, post-approval changes, and regulatory risk mitigation.

He has authored multiple peer-reviewed publications, accumulating over 700 citations, reflecting the impact of his research in microbiology and biochemistry. His collaborative work with international researchers has advanced the scientific community’s understanding of bacterial enzyme functions and metabolic pathways.

Dr. Christensen’s experience spans pharmaceutical starting materials, drug substances/APIs, adventitious agent (viral and microbiological) safety testing, potency testing, strain development, and due diligence of data supporting pharmaceutical product manufacturing claims.

He holds a Ph.D. in Microbiology from the University of Illinois Urbana-Champaign, where he studied in the laboratory of Prof. John E. Cronan, and completed a postdoctoral fellowship at the University of Washington with Prof. E. Peter Greenberg. Contact Quin.