PROCESS DEVELOPMENT, SCALE-UP & OPERATIONS EXECUTIVE Leadership Expertise: Widely respected and recognized as a leader and has served as a resource for senior management. Led teams from small, short-time focused groups to a 100-person department with six direct reports. Led development of twelve processes to NDA submission. Long history of mentoring junior level engineers by providing guidance and direction as they progressed within the company. Process Development Expertise: Expert in process understanding, process development, and process scale up. Utilizes first principle understanding of process parameters and their effect on quality attributes. Comfortable working with Quality by Design principles including Target Product Profiles, Design of Experiments, process statistics, control strategies, troubleshooting, and root cause analyses. Operations Expertise: Experience in all aspects of drug development operations including working with CDMO / CMOs, regulatory documentation, cGMP compliance, sterile design, SIP, CIP, validation, CMC product teams, clinical manufacturing, operations, pharmaceutical equipment design, FATs, P&IDs, PFDs, process descriptions, quality assurance, risk analyses, SOPs, and batch records. Seeking VP or SVP Position in Process Development and/or Operations in a small or virtual Pharmaceutical / Biotech company.Contact: paul.fritz.herbert@gmail.com