TOSCANO CONSULTING GROUP - Key Persons
Job Titles:
- Associate at Toscano Consulting Group, Inc
Job Titles:
- President of TCG
- President of Toscano Consulting Group, Inc
George Toscano, President of Toscano Consulting Group, Inc. (TCG), has more than 20 years of experience helping companies in the global pharmaceutical, biologic and medical device markets develop and execute comprehensive quality systems solutions. He is a recognized Data Integrity expert and has conducted numerous audits and assessment to evaluate quality systems. In addition, he has led global remediation activities related to Data Integrity deficiencies to help clients both domestic and international address regulatory enforcement actions.
Mr. Toscano's technical background and broad range of experience includes validation, vendor qualification, auditing, batch record review, product release and stability, investigation of non-conformances, and current Good Manufacturing Practices (cGMP) training. He has provided hundreds of companies with expert counsel on laboratory and manufacturing investigations, Corrective and Preventive Actions (CAPA)
development and implementation, training, stability programs and other quality systems. He also has served as project lead and expert consultant on compliance initiatives involving corporate 483 responses, warning letters, consent decrees and application integrity policies (AIP).
As President of TCG, Mr. Toscano assists companies in the pharmaceutical, biologic and medical device industries, both foreign and domestic, in developing compliant quality and regulatory strategies. Mr. Toscano also specializes in supporting companies address quality system deficiencies through conducting GMP assessments.
Mr. Toscano previously served as the Vice President of Quality Systems, NSF Health Sciences Pharma Biotech Consulting where he managed the consulting practice. He has also held senior executive positions for several pharmaceutical and biotechnology companies. Mr. Toscano has an MBA from Florida Atlantic University and a Bachelor of Science degree from the University of Central Florida.
Job Titles:
- Director of Operations at TCG
- Director of Operations at Toscano Consulting Group, Inc
Jera B. Lindsey, Director of Operations at Toscano Consulting Group, Inc. (TCG) has over 10 years of experience strategically managing organizational and operating systems at various companies. She has extensive experience in managing project timelines, budgets, over 80 consultants and project deliverables on numerous high-profile Pharmaceutical, Biotechnology, and Medical Device client accounts; to ensure quality compliance with various regulatory entities. She has also served as a project manager on project initiatives including corporate 483 responses, Corrective and Preventive Action (CAPA) development and implementation plans, and remediation projects.
As the Director of Operations at TCG, Mrs. Lindsey manages client engagements and coordinates client deliverables to ensure timelines are achieved through the utilization of tactical project planning, management, training, and timely communication. She also specializes in team building strategies, nonprofit management, organizational behavior and theory.
Mrs. Lindsey obtained her business degree in Organizational Leadership and Management from Fresno Pacific University with a certification in CMTC Export Strategy & Acceleration Systems.
Job Titles:
- Associate at Toscano Consulting Group, Inc
K. Rao Gurijala, Ph. D. MBA, Associate at Toscano Consulting Group, Inc. (TCG) has more than 20 years of quality systems experience in global Pharmaceutical, Biologic and Medical Device industries. He is certified Lean Six Sigma Black Belt and ISO lead auditor. He has conducted numerous audits and assessments to evaluate quality systems. He is a globally recognized expert in Aseptic Processing, Microbiology, Sterilization Sciences, and Environmental Monitoring.
Dr. Gurijala's technical background and broad range of experience includes method validation, auditing, batch record review, product release and stability, investigation of non-conformances, and current Good Manufacturing Practices (cGMP) training. He has experience in laboratory and manufacturing investigations, Corrective and Preventive Actions (CAPA), microbiology, aseptic processing, and stability programs.
Dr. Gurijala previously served as Business Unit Leader of Global Quality at Bausch and Lomb, where he managed the quality operations at 35 distribution centers world-wide and corporate center for microbiological excellence. Prior to that he has held senior executive positions for several pharmaceutical and biotechnology companies.
Dr. Gurijala received his Ph. D from Cornell University in Environmental Microbiology and an MBA from University of Rochester. He received MS from Punjab Agricultural University and BS from Andhra University, both in India.
Laura Furr, Consulting Practice Manager at Toscano Consulting Group, Inc. (TCG) has over 10 years of diverse experience in marketing and communications roles. She also has several years of experience as a Regulatory Affairs Associate with expertise in electronic submissions for the FDA, working with device companies and industry consultants. As the Consulting Practice Manager at TCG, Laura facilitates clear communication among TCG consultants and clients. She helps ensure the quality and delivery of client work product and manages various consulting practice needs. Ms. Furr obtained her MA degree in Advertising from the Moody College of Communication at the University of Texas in Austin and her BA in Communications from Elon University in North Carolina. She also specializes marketing with a specialty in advertising, social media and nonprofit fundraising. In her spare time, she enjoys travel, cooking and volunteering.
Job Titles:
- Vice President at Toscano Consulting Group, Inc
- Vice President of TCG
Nicholas O. Markel, Vice President at Toscano Consulting Group, Inc (TCG) 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 been providing general and strategic consultation to domestic and foreign clients in the Biotech and 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 the development and implementation of sustainable solutions to a variety of technical and quality related problems and as part of proactive continuous improvement efforts.
Immediately prior to joining TCG Nicholas previously served as the Vice President of Pharma Biotech North America for NSF Health Sciences. Mr. Markel has a Bachelor of Science Degree in Biology from St. Mary's College of California in Moraga, CA.