I am the founder and principal consultant at Bento Consulting, LLC with over 26 years of operational and leadership experience in developing cell/gene/regenerative medicine therapeutics across the CMC operation, MSAT, process development and analytical development in both academic and biopharmaceutical industry to support early to late-stage clinical development and commercialization.I have built and qualified multiple cGMP manufacturing facilities, established quality organizations from scratch and led regulatory CMC activities for INTERACT, pre-IND, IND and BLA submissions. Additionally, I have extensive experience in selecting, qualifying, and managing global Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), and Contract Testing Laboratories (CTL) ensures seamless technology transfer and process scale-up/out, optimizes cost and timeline, while maintaining phase appropriate level of quality. My operational expertise covers the entire vein-to-vein supply chain logistics as I have actively managed and supported critical aspects of clinical supply operations, overseeing biological starting material collection centers, raw materials, and reagents (e.g. pDNA, mRNA, viral vectors, peptides) suppliers, courier service providers, and storage/distribution partners. With a keen eye for detail and a focus on quality, while mitigating risks throughout the process, I ensure smooth operations at every step, right up to product administration at clinical sites.Furthermore, with my training in medical technology and passion for process and analytical automation I am well versed in navigating the rapid world of emerging technologies. I have a proven track record of successfully launching cell engineering manufacturing enabling platforms and consumables with proficiency in technology selection, adoption, platform design, development, validation, and lifecycle management.