Profile

Mr. Norman Goldschmidt

Contact Details

Bio

Norman Goldschmidt has almost 35 years of Life Sciences experience in roles spanning the many operations necessary to bring Life Science products to from bench to market. From his start at a Penicillin plant in Syracuse, NY - through assignments in R&D, OSD, High Containment, Biotech, Sterile Manufacturing and ATMPs to his leadership of Global Capital Strategy and Design at Bristol-Myers Squibb; Mr. Goldschmidt has been “hands-on” with every type of facility and process. He now serves as the President of Genesis AEC, a full service Consulting, A&E, Construction and CQV firm specializing in highly technical facilities for regulated companies.

 

Norman is internationally recognized as an Expert in Control of Critical Environments for regulatory compliance and risk management in Life Sciences. He has extensive experience in engineering and regulation for BPC API, Oral Dosage, ATMPs, Sterile filling, Vaccine and Biotech API processing, Pharmacies /Dispensing and associated R&D. He is a regular instructor for ISPE and other professional societies or regulatory agencies (FDA, USDA, NIH, HCA, TGA and MHLW) providing training to Life Science professionals around the world. At the Graduate level, he has been an adjust professor for NJIT’s Masters in Pharmaceutical Engineering program. Mr. Goldschmidt holds 4 patents for innovations in HVAC and Pharmaceutical Processing, is an International Standards Organization (ISO) cleanroom expert/author and convenor for the ISO standard for separative devices (Isolators and RABS).

He has been a contributing author/editor of 7 ISPE Guides in addition to numerous articles and papers and a reviewer for many more. Norman has served as the Chair and Co-chair of the HVAC and sustainability COP and has helped moderate the forums for this COP. Norman has authored and taught the HVAC and environmental control class for over 15 years as well as the Aseptic and other ISPE classes.