Edward N. Pedersen
Mr Pedersen has over 40 years of experience in the design and management of facility projects for biologics, biopharmaceuticals, cell and gene therapy, antibodies and biosimilars. His experience spans site evaluation, concept design through construction, building code analysis, construction site technical support and project management for labs, warehouse, administrative, utilities and site security systems. He has worked with the numerous teams as Process Architect and Master Planner to interpret PFDs for equipment needed, the sequence and space for unit operations, and the product material inputs and utilities, inclusive of considerations for adjacencies of unit operations with layouts as well as FDA regulatory requirements. Mr. Pedersen has extensive experience in programming of API, primary and secondary manufacturing, lab module requirements for R&D, macro bench scale-up, stability, virology, pharm/tox, immunology/cell biology, microbiology, chemical, pharmaceutics, genetics, combinatorial chemistry, analytical microbiological, trace-level radio isotopes, robotics, QA/QC, raw material sampling and testing labs. Ed is a member of the American Institute of Architects, the International Code Council and ISPE where he has completed courses in cGMP, GLP, barrier technologies/potent compounds, aseptic processing and biotechnology facility design as well as serving as past local chapter board member, program committee chairman, newsletter editor and presenter at various national chapter forums. Ed received his Bachelor of Architectural degree from Pratt Institute and his commission in the USNR upon graduation where he served as Asst Public Works officer in the Seabee base in Gulfport, MS. After completing military service he attended Columbia University and with a MS in Urban Planning.