Quality Systems Specialist
Committee Member, Speaker Outreach & FDA Liaison
Since 2003 Amy has held multiple positions within the Quality Organization at Amgen, most recently as a Quality Systems Specialist in External Affairs. While at Amgen she worked to develop, implement and helped to maintain the GMP Regulatory Intelligence Program, which includes surveillance, analysis and communication of GMP related regulations, guidance and enforcement activities. She is co-founder of the Regulatory Intelligence Discussion Group (RIDG), an industry group working together sharing best practices and knowledge in relation to GMP and GDP Regulations. She is an active member of PDA and other industry and local organizations. Previously Project Manager (PM) for PDA Technical Report No. 74 Reprocessing of Biopharmaceuticals and currently, PM for the PDA Team on Achieving ″Zero″ Defects for Visible Particles in Injectables. Amy received both her Bachelor of Science and her MBA from California Lutheran University.
Western Region Sales Manager
Particle Measuring System
Chairperson, Membership & Corporate Outreach
Over 20 years' experience in pharmaceutical raw material supply chains and sterility assurance, primarily with Spectrum Chemical and Thermo Fisher. Currently assisting Particle Measuring Systems client's with technology-driven environmental monitoring process improvements using scientific methods, while achieving GMP compliance and regulatory approvals. Over the last 5 years Gary has been involved in initiatives bringing cutting edge Process Analytical Technologies and Rapid Microbial Methods that improve quality and process to the life sciences community.
Validation Technologies, Inc.
Chairperson, Vendor Outreach
Committee Member, San Diego Events & Program Committee
Mr. Matheson has been working within the Life Sciences industry for over 35 years after graduating from Michigan State University with a B.S. in Microbiology and Public Health. During that time, he has worked for both operating companies and service providers within the Engineering and Quality Assurance departments in positions mostly related to the commissioning and qualification of facilities and processes.
For the past 23 years he has been the co-founder and President of VTI Life Sciences (formerly Validation Technologies) and has been responsible for providing commissioning and qualification services to companies within the FDA regulated life science industries both within the United States and internationally.
I look forward to bringing my experience as a service provider and as a business owner who recognizes the importance of professional development to employees, to assist the SoCal PDA to provide continuing education to professionals involved in the pharmaceutical and biopharmaceutical industry.
KGI Graduate Institute
Student Chapter President, 2018-2019
Committee Member, Events & Programs
Indah is a second-year Master of Business and Science student, majoring in Regulatory Affairs at KGI. She obtained her Bachelor of Science in Molecular Environmental Biology from University of California, Berkeley. Prior to KGI, Indah worked as an Immunology Research Associate at a diagnostic reagents company. She also had the opportunity to perform a pre-clinical study on microbiome and Crohn's disease at Sarkis Mazmanian Lab, Caltech in collaboration with AbbVie Inc. She is currently doing her regulatory affairs summer internship at MicroVention Inc. As the President for the SoCal PDA Student Chapter, Indah is dedicated to advancing the chapter's mission by connecting KGI community with professionals in the life science industries.
Chairperson, Student Chapter & Young Professionals
Jason Kerr is a QA Manager at Amgen's External Affairs Quality department and stays up to date on GMP changes in the global landscape. Prior to Amgen, Jason has worked with Shire Pharmaceuticals for two years in material qualification for extractable and leachable on single-use systems and raw material validation. He received his Bachelors in Biochemistry from UCLA in 2014 and his master's in business and Science (MBS) focusing on Clinical and Regulatory Affairs from the Keck Graduate Institute (KGI) in 2016. He also holds a Certificate in Bioscience Industry Law and Practice from the Southwestern Law School in 2016 and received his MBA through Smartly in 2017.
Jason is currently on the planning committee for the 2019 PDA Annual Meeting representing Young Professionals.
Director of Business Development
Committee Member, San Diego Events & Program Committee
Committee Member, Student Chapter & Young Professionals
Molly Blazek is the Regional Sales Manager for the Western U.S. for OCEASOFT, an environmental monitoring company specializing in wireless sensors and data transmission, data integration in back-end information systems, calibration, IOT and software platform development. Molly has been in the life science industry for 6 years, starting with data management at the Salk Institute for Biological Sciences. She is an active member of PDA, assisting with the development of San Diego and the Student Chapter/Young Professionals. Molly obtained her Bachelor of Arts and Master of Arts at University of California, San Diego, and San Diego State University, respectively.
Business Development Manager
Committee Chairperson, San Diego Events & Program Committee
Corporate Recruiter, Life Sciences Division
The Recruiting Collective
Committee Chairperson, Philanthropy & Donations and Events & Venues