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Replies to post #152839 on Avid Bioservices Inc (CDMO)
Avid Leadership Team
Gene Yoshioka
Director, Manufacturing
Gene Yoshioka heads the Manufacturing Department at Avid Bioservices and oversees the cGMP manufacturing operations, with almost 20 years of experience working in the industry. Gene originally joined the organization in 1995 working for Avid’s parent company, Peregrine Pharmaceuticals where he was involved in various aspects of the organization including Quality Control, Manufacturing, Supply Management, and Research & Development. Upon Avid’s inception in 2002, Gene served as the Project/Production Manager helping to establish Avid as a successful Contract Manufacturing Organization. Gene earned his B.S. in Biology at the University of California, Irvine and has also garnered experience at Amgen Incorporated and IDEC Pharmaceuticals.
April Loui
Director, Quality Assurance
April brings over 19 years of experience in the industry and leads Quality Assurance Operations for Avid Bioservices. Her leadership principles are based on maintaining a cGMP compliant operation and providing safe, quality supply to the patient without compromise. Prior to joining Avid, April was on the core team to build and start up a greenfield Fill/Finish Facility for Genentech in Oregon. She formerly managed commercial U.S. and International contract manufacturing operations (CMO) in cGMP Aseptic Filling, Labeling and Packaging for Genentech, SSF. She made significant contributions to commissioning new facilities, product launches and establishing quality systems for standardized CMO management. Prior to joining Genentech, April held progressive positions in Process Development, Manufacturing, Quality, and Regulatory Affairs at Bayer. Her roles supported the startup of a new cGMP facility (Cell Culture through Fill/Finish) and international licensure of new and existing drug products. April earned her Master’s in Business Administration from St. Mary’s College, Bachelor of Arts in Integrative Biology from UC Berkeley, and has completed post-baccalaureate studies in Epidemiology. She has also completed executive leadership programs at Harvard Business School and is an ASQ-Certified Six Sigma Black Belt.
Jaime Kennedy
Senior Manager, Business Operations
Jaime Kennedy brings over 13 years of experience in the industry and provides a single point of contact for all client relations, as well as one standard policy/format for all proposals and communications. Jaime joined Avid in 2007 and has extensive experience in process tech transfer, development and validation, as well as designing programs to support clinical and commercial supply. By working closely with Avid’s customers, she creates customized timelines for each client that includes all client projects, with expected completion dates and deliverables. Prior to joining Avid, Jaime was with ISTA Pharmaceuticals and Focus Diagnostics. She holds a Bachelor of Science Degree in Biology from California State University, Fresno.
Michael S. Molony
Director, Quality Control
Michael Molony started as Director, Quality Control in July of 2013. Mike is responsible for ensuring the integrity of Avid QC’s methods and accompanying results for GMP lot release, stability and raw materials. Prior to joining Avid, Mike served most recently as Director of Analytical Testing and CMC Projects at Allergan and Associate Director of QC and Analytical Development at Gilead Science. He has also served in various Quality Control and Analytical Development roles at Biogen-Idec, Genentech and Applied Biosystems over the span of his 25+ year career. His areas of expertise include statistical analysis, process analytical technology (PAT), analytical method development, product characterization and CMC sections of regulatory filings. His CMC related experience range from individual contributor to CMC team leader and he has been involved in 20+ regulatory filings for molecules at various stages from phase I to commercial. Mike earned his Master’s degree in cell and molecular biology from San Francisco State University and his Bachelor’s degree in microbiology from the University of California, Santa Barbara.
Ray Marzouk
Associate Director, QC Microbiology
Ray Marzouk heads the Quality Control Microbiology Department and is responsible for Avid’s environmental monitoring program and microbiological testing functions, as well as the visual inspection program. Ray joined Avid in 2007 and prior to that, he was with B. Braun Medical Inc. and has over 18 years in the biopharmaceutical and pharmaceutical industry. He has a Bachelor of Science Degree in Microbiology and Molecular Genetics from University of California, Los Angeles. Ray is a Specialist Microbiologist with the National Registry of Certified Microbiologists, [SM]NRCM.
Steven Chamow, Ph.D.
Head of Technical Services
Steven Chamow, Ph.D. has over 20 years of experience in biopharmaceutical product development. Previously he served as Senior Vice President, CMC at Intradigm Corporation, a private biopharmaceutical company focused on developing RNAi therapeutics. Prior to Intradigm, Dr. Chamow was Vice President, Process Sciences at Genitope Corporation and at Abgenix, Inc., where he established the company's process sciences department and helped lead the design and construction of its award-winning production facility in Fremont, CA. He served as Director of Biopharmaceutical Development at Scios, Inc. and as a Scientist and Senior Scientist in Genentech's Process Development department. During his career, he contributed to the development of three commercial biotherapeutics: Avastin®, Natrecor®, and Vectibix®. He earned a B.A. in biology from the University of California Santa Cruz, a Ph.D. in biochemistry from the University of California Davis, and completed postdoctoral training at the National Institutes of Health. He is author or co-author of more than 45 scientific publications and patents and is co-editor of a 1999 book entitled Antibody Fusion Proteins.
Teresa Berry
Director, Engineering and Facilities
Teresa Berry heads the Engineering and Facilities Departments at Avid Bioservices. With over 22 years of experience in the biopharmaceutical industry she oversees the day to day facilities’ operations from Preventative Maintenance and Calibrations to construction projects. Teresa established robust cGMP programs for equipment and utility systems when she originally joined the organization in 2001 working for Avid’s parent company, Peregrine Pharmaceuticals, Inc. In 2002, Teresa was an integral team member involved in the launch and establishment of Avid Bioservices as a successful Contract Manufacturing Organization. Teresa has her Bachelor of Science Degree in Health Sciences from the University of California, Long Beach and is a member of the International Brotherhood of Electrical Workers, as a Journeymen Inside Wireman. In addition, she is a long standing member of the ISPE. Teresa got her start in biotechnology with XOMA and Agensys. She also has over 12 years of experience in the construction industry; this expertise allows her to service Avid’s needs.
http://www.avidbio.com/about-us/avid-leadership-team.html
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