CPCI™ Board of Directors

As a not-for-profit 501(c)(3) organization, CPCI™ is required to have a Board of Directors. Directors should be individuals that are stakeholders in the activities and success of the organization. Consequently, CPCI™ has comprised its Board with Members from the ASTM Cleaning Standards Team who helped create the ASTM E3106 Standard Guide "Science-Based and Risk-Based Cleaning Process Development and Validation". In addition, CPCI™ Board members have been selected from current and former CPCI™ employees and individuals who have shown an interest in the activities and success of CPCI™.

The following people are the current members of the CPCI™ Board of Directors
Alfredo Canhoto, Ph.D
Alfredo has been involved with the ASTM Standards creating process since its beginnings in 2007. Alfredo is a Senior Manager at Alnylam Pharmaceuticals and has over 20 years of industry and consulting experience specialized in biopharmaceutical validation, process and cleaning validation, development and program implementation, laboratory experimentation and instrumentation qualification, authoring articles and chapters and speaking on the same.
Parth Desai
Parth is the Validation Manager at Nostrum Laboratories. While working at Stevens Pharmaceutical Research Center (SPRC), Parth  managed three (3)  studies on visual inspection, the development of Total Organic Carbon and conductivity analyses, and the application of design of experiments in cleaning process development for a cosmetic product. Parth's visual inspection studies were published in Pharmaceutical Online in 2017. Parth has over 12 years of experience in the pharmaceutical industry.  In his current role, Parth is responsible for leading and managing the validation and technology transfer group, calibration group, serialization group, product launch and OpEx initiatives at multiple Nostrum sites.  Parth holds an MS in Pharmaceutical Manufacturing and Engineering from Stevens Institute of Technology.
Jayen Diyora
Jayen has over 13 years of experience in the biopharmaceutical industry and recently joined CPCI™ as a Principal Validation Specialist managing the CPCI™Laboratory. Prior to CPCI™ Jayen was a Senior Manager for Cleaning Validation Engineering at Bristol Myers Squibb (BMS) where he held a multi-faceted role of implementing and maintaining an effective cleaning validation lifecycle for a multi-product biologics manufacturing facility. Prior to BMS, Jayen worked for 6 years at Alnylam Pharmaceuticals as a Principal Validation Engineer where he led cross-functional teams focused on cleaning verification programs and was the site lead for the qualification of facilities, equipment, and utilities. Prior to that, Jayen worked at Biogen for four years, specializing in cleaning and sterilization validation. Jayen holds an MS in Engineering Management from Tufts University and an MS in Pharmaceutical Manufacturing and Engineering  from Stevens Institute of Technology
Igor Gorsky
Igor has been involved with the ASTM Standards creating process since 2015. Igor has been a pharmaceutical, biopharmaceutical and medical device industry professional for over 36 years. He held multiple positions with increasing responsibility at Alpharma (Actavis), Wyeth (Pfizer) and Shire (Takeda). He worked in Production, Quality Assurance, Technical Services and Validation including aa a Head of Validation of the Global Pharmaceutical Technology at Shire (Takeda). He is currently holding a position of a Senior Consultant at ValSource, LLC.  Igor has published numerous articles and white papers in pharmaceutical professional magazines and textbooks. He holds a BS degree in Mechanical/Electrical Engineering Technology from Rochester Institute of Technology.
Mariann Neverovitch
Mariann is a Senior Manager at Bristol Myers-Squibb. Mariann is a Cleaning Validation Subject Matter Expert with 15+ years of experience in cleaning verification method development and support. Mariann has been leading cleaning verification program in Support of Clinical Supply Operations for ten years. She has presented a number of papers on Cleaning Validation Lifecycle management and co-authored number of papers along with the international team of industry experts on Cleaning Validation in the 21st Century.
Ovais Mohammad
Ovais has been involved with the ASTM Standards creating process since its beginnings in 2007. Ovais is a Subject matter expert on cleaning/process validation, quality assurance and quality risk management with more than 20 years of experience working in regulated pharmaceutical environments and has published several articles on cleaning validation issues. Ovias' technical expertise covers many areas of product/process development, validation and quality assurance including – life cycle management of product and processes, quality by design, quality risk management, quality planning, root cause analysis, formulating corrective and preventive actions, technology transfer, equipment qualification, validation of cleaning and manufacturing processes, and dossier preparation and review. Ovais has extensive experience in technical writing including authoring policies, master plans, protocols, company procedures and reports.
Osamu Shirokizawa
Osamu has been involved with the ASTM Standards creating process since its beginnings in 2007. Osamu is President and CEO of LifeScientia a consulting company in the Life Sciences in Japan. In addition to being a CPCI™ Board Member, Osamu is also on the Board of Directors of the Parenteral Drug Association (PDA)
Ruijin Song, MS
Ruijin is a Senior Validation Specialist at Beigene supporting cleaning validation at their new facility in Hopewell, New Jersey. Prior to her position at Beigene, Ruijin was a Senior Validation Specialist at CPCI™ for 7 years where she was engaged in extensive research on cleanability studies, including determination of "hardest-to-clean" products, cleaning agent selection studies, "time-to-clean" studies, and design of experiments to optimize cleaning processes for internal research and for CPCI™ clients. Ruijin also has extensive experience in TOC and UV-Vis method development and validation, swab recovery studies, and the qualification of Visual Inspection. Ruijin has an MS in Chemical Engineering from Columbia University and an MS in Material Science from Tongji University.
Joel Young
Joel is an Executive Director at Bristol-Myers Squibb, leading the global analytical organization responsible for method development in support of Phase 1 drug substance processes, release and stability testing of pharma clinical supplies, method validation, method transfer, registrational stability testing and commercialization of analytical methods.  Joel has been involved with the ASTM Standards creation process since its beginnings in 2007.