Nicholas O. Markel
Vice President
Nicholas O. Markel is Vice President at Toscano Consulting Group, Inc. (TCG). Mr. Markel brings over 30 years of experience in the Pharmaceutical and Biopharmaceutical field. The first 15 years of his career were spent with top Biopharmaceutical companies such as Genentech, Alexion, and Idec (now Biogen). He also worked for an autologous cell therapy company (Xctye Therapies). He has held roles including Associate Director and Director of Manufacturing and GMP Operations and has helped to design, build, and quality several facilities for the manufacture of recombinant proteins, monoclonal antibodies, and autologous T-cells.
Since 2006, Nicholas has provided general and strategic consultation to domestic and foreign clients in the Biotech and Pharmaceutical industries, assisting with manufacturing issues, development of quality systems, and regulatory strategies. This work has included a wide variety of projects providing technical consulting services, person-in-plant services, third-party batch review and certification, optimization of fermentation and purification processes, execution of over 100 audits and assessments, design and redesign of quality systems, writing and reviewing CMC portions of a variety of Regulatory Filings such as INDs, CBE-30s, and 32A1 sections of BLAs, as well as provided assistance with a variety of remediation activities including responding to 483 inspectional observations, warning letters, and import alerts.
Nicholas’ areas of expertise include techniques used in biopharmaceutical production for human use, revision and development of Quality Systems, conducting cGMP compliance audits, deviation investigation, CAPA and Effectiveness Check generation and implementation, person in plant oversight of manufacturing contractors and manufacturing activities, overall project management, design and commissioning of new and revised facilities, assisting clients with overcoming regulatory actions (e.g. Import alerts and Warning Letters), and authoring procedures, FDA submittals, plans, protocols, and reports.
As Vice President of TCG, Mr. Markel assists foreign and domestic companies in the pharmaceutical and biologics industries with developing and implementing sustainable solutions to various technical and quality-related problems as part of proactive, continuous improvement efforts.
Mr. Markel previously served as the Vice President of Pharma Biotech North America for NSF Health Sciences. He has a Bachelor of Science Degree in Biology from St. Mary’s College of California in Moraga, CA.