Genesis AEC supports the Life Sciences from Discovery through Production with Engineering, Architecture, Consulting, Construction, Commissioning, Qualification and Asset Management. As the President of Genesis I keep the organization aligned with industry trends and needs. As an ISPE international Board member, ISO TC 209 (14644) US expert and author, international trainer and regulatory consultant - I work to help guide the industry to embrace science in all facets of our work.I also actively support our clients by leveraging my extensive experience in BioPharmaceutical Manufacturing and R&D including: Sterile filling / Vaccine and Biotech API processing / Cell & Gene Therapy / and operations management.Our dedicated, innovative and experienced staff combine business insight with technical expertise to deliver projects and services with exceptional value and speed. My Specialties include:Management - Strategic Planning - Energizing and Developing People - Process Improvement / Change Mgmt. - Capital Planning - Program and Project ManagementTechnologies - Pharmaceutical Manufacturing Operations, Engineering and Regulation - Environmental Control and ComplianceBiotechnology Facilities and Process Integration - Cell and Gene Therapy Facilities and Operations - Aseptic Facilities and Processes - Medical Device industry - Pilot Plant Engineering and Regulation - Risk Management - Sustainability & Energy Conservation - Critical Environments / HVAC /Utilities - Environmental Monitoring - BMS/ EMS Computer System Validation - Facility & Process Validation - Validation documentation and Validation activities
Listed skills include Validation, Gmp, Pharmaceutical Industry, Cross Functional Team Leadership, and 45 others.