Alex Armendariz has worked in pharma/bio for over 19 years applying his knowledge and expertise to manufacturing and quality systems. He has worked to develop state-of-the-art technical training and quality programs in a cGMP environment. His career began by working as an aseptic operator in a contract manufacturing sterile injectable facility, followed by various roles in quality documentation control, manufacturing management of APA areas, and training.
Alex has increased recordable and effective training events consistently year to year. He has implemented systems for compliance, employee onboarding, training event tracking, and job requirement competencies. Alex has developed compliance training programs on topics including but not limited to GxP refreshers, audit responses, regulatory updates, and Corrective Action Preventive Actions (CAPAs).
Alex has experience leading key initiatives and establishing new processes in a remediation environment. He has led key continuous improvement initiatives including skills balancing, cycle time reduction, and reducing defects.
Alex Armendariz has a B.A. in Communications, an M.S. in Instructional Design and Technology, and is a certified Lean Six Sigma Black Belt. He is currently a Doctoral Candidate in Organizational Change and Leadership at the University of Southern California.
Dr. Pinar Cicalese has held various technical and management roles at GSK, EMD Pharmaceuticals, and Sequel Genetics during her over 15 year career in the biopharmaceutical industry. Her experience encompasses early R&D, late stage development and commercial manufacturing support of bioprocesses. Her skills span bioprocess engineering, molecular biology and technology transfer of mammalian and insect cell cultures. Dr. Cicalese has led scale-up and process transfers for clinical and commercial manufacturing processes using batch, fed-batch, and perfusion technologies. She has a proven track record of managing technical teams for process development, new product launches and validated products with successful process improvements.
In her current role as Global Product Owner, Dr. Cicalese provides leadership to various business units by ensuring process understanding, control, and capability is maintained over a product’s global supply chain. She is responsible for management of changes and potential risks via cross-functional planning, negotiation and influence at all levels of the organization.
Earlier in her career, Dr. Cicalese was an Assistant Professor in Molecular Biology and Genetics and taught various Chemical Engineering and Molecular Biology related courses in a variety of universities.
Dr Cicalese obtained her Ph.D. in Chemical Engineering from Drexel University where she was the recipient of the Mollye and Mitchel Glick Scholarship and The Merck Scholar Award. She was also a Fulbright Scholar during her Ph.D. She has a Master in Science and Bachelor in Science degrees in Chemical Engineering from Bogazici University in Turkey.
Dan has served in various technical and management roles at GSK, Stryker, and Eli Lilly over his 25 year career in the biopharmaceutical industry. His experience has encompassed both R&D and commercial manufacturing support of bioprocesses involving bioreactors and chromatography purified and lyophilized proteins. His skills span bioprocess sciences, bioprocess engineering, and technology transfer from bench-top to pilot plant mammalian and algae cell culture, as well as large-scale yeast and microbial fermentation. Dan has led scale-up and process transfers for early and late stage clinical trial manufacturing processes using batch, fed-batch, perfusion, and packed-bed technologies. He has a proven track record of managing GMP technical support teams of both new product launches and validated legacy products with successful process improvement efforts.
In his current role as a Product Owner, Dan provides leadership by ensuring that process understanding, control, and capability is maintained over a product’s global supply chain throughout its commercial life on the market. Knowledge management involves capturing both historical development knowledge of, and tacit awareness about, a process and making sure it is available, shared, applied, and refreshed as time evolves. Management of changes and assessing potential impact and risks are key aspects for this role, in addition to cross-functional planning, negotiating and influencing at all levels of an organization.
During his career, Dan has been a member of the Vermont Technical College Biotech Advisory Board, a Business & Education Partnership trainer in New England’s Upper Valley, and was recognized with a world class rating in the Gallup Organization’s Great Manager Program. He is a life member of the Tau Beta Pi Engineering Honor Society and rotates membership in the American Institute of Chemical Engineers, American Chemical Society, International Society for Pharmaceutical Engineering, and Parenteral Drug Association. He has contributed to over ten industry publications and presentations.
Dan has a Masters in Science of BioChemical Engineering from Tufts University where he was a recipient of the Stanley Charm Scholarship in Food & Biotechnology and the INDA Council of Universities Academic Research Grant, and a Bachelor of Chemical Engineering degree from The Catholic University of America. Dan grew up in, and is now a current resident of Pennsylvania, but has also lived and worked in Maryland, Massachusetts, Indiana, and New Hampshire.
Rod Goodson received his BS in Engineering from California Polytechnic University, San Luis Obispo, and his MS in Quality Assurance from California State University, Dominguez Hills.
Rod has spent his professional career as a senior and staff engineer in research, product/process development, manufacturing, and quality assurance. His engineering experience in precision materials and electronic manufacturing includes GTE, Smith International, Form Physics, and Printronix. Rod also served as a senior and staff engineer at the following medical device and biotechnology companies in San Diego: Advanced Tissue Sciences, Pilkington Barnes-Hind, Smith & Nephew Wound Management, and Illumina. Rod has extensive experience in design development, medical device manufacturing, and quality improvement techniques. He has been a project manager for design, scale-up, and transfer of processes from laboratory through manufacturing. He is proficient in validations, Statistical Process Control, Design Reviews, Q.S.R. requirements, design of experiments, capability studies, and other statistical methods. Rod founded Good-Engineering Consulting and continues to provide professional engineering services to life sciences companies.
Joe Lingle joined the Sandoz North America team in December 2013 to lead the organizational effectiveness, learning and development function, having previously worked in another division of Novartis (Vaccines & Diagnostics) since May 2009. Joe started at Novartis as the Head of Bulk Manufacturing at the Holly Springs, NC site where he was responsible for leading the bulk manufacturing team as well as the acceleration of their adjuvant line. In October 2009, Joe was appointed Head, Global Program Integration and joined the TechOps Leadership Team. In this role, Joe was responsible for leading global, cross-functional project teams in developing integrated strategic and operational plans, improving operations, and ensuring efficient governance of the operations management team. During his tenure, Joe also worked on a development assignment in Global HR where he supported the Global Public Health & Market Access (GPHMA) team as their HR business partner.
Prior to joining Novartis, Joe held manufacturing, logistics, supply chain, and engineering positions of increasing responsibility with Merck and GSK. Joe’s role at GSK at his time of departure was Director of Facility Operations. Prior to working in the pharmaceutical industry, Joe spent 8 years with a design/consulting engineering firm.
Joe has a Bachelors and Masters in Engineering, both from Villanova University. He is also a licensed Professional Engineer in the Commonwealth of Pennsylvania and a Senn-Delaney (Leadership Edge/Live The Values) accredited facilitator.
Dr. Ben Locwin is a highly-sought after author, speaker, and leader in the pharmaceutical industry, where his focus is on strategic leadership, quality improvement, statistical process control, and interpersonal psychology. He also is an active professor of business management and psychology/neuroscience courses, and consults for a variety of industries including pharmaceutical, chemical, food and nutrition, academic, psychological sciences, and forensics.
He has been elected to the Association for Psychological Science, the American Psychological Association, the American Society for Training and Development, the Society for Industrial and Organizational Psychology, and is on the board for the Association for Pharmaceutical Sciences Nutraceuticals and Natural Products Chemistry Focus Group. He frequently writes about a number of science and healthcare-related topics in magazines and books.
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