Jun Edo Orlanes, MBA, DBA, LSSMBB, ASQ, GxP, ISO, PMP

Global Alliance Director, Liaison, GMP, CMO/API Tech Transfer Remediation, FDA PAI, OpEx at Taiho Oncology, Inc.

Jun Edo Orlanes, MBA, DBA, LSSMBB, ASQ, GxP, ISO, PMP has an extensive work experience in project management, operations, regulatory affairs, and quality management. They have held various leadership positions in prestigious organizations such as Takeda, Taiho Oncology, The Janssen Pharmaceutical Companies of Johnson & Johnson, Moderna, Emergent BioSolutions, Vizient Inc, Kaizen Institute, MetLife Japan, Greenway Health, and FDA.

Throughout their career, they have managed multiple projects and initiatives related to CMO/Tech-Transfer, CMC/RA, PMDA/MHLW NUVAXOVID COVID-19, MODERNA Logistics OpEx, GMP, CMO/API Tech Transfer Remediation, FDA PAI, CAR-T, CARVYKTI, GxP Mfg Ops, MA, CMC, RA, QA/QC, Clinical Trial, COVID mRNA-1273 LNP, GMP Manufacturing, Scale-up, Tech-Transfer Lonza, Global Medical Countermeasure, RA, FDA/Health Canada, BLA, MPOX/VIG, Supply Chain, GPO, EUA/COVID19, DHS/ASPR/BARDA/USA Mass Vax Initiative (Pfizer/Moderna/J&J), Agile/Lean MBB Management Consultant (Japan & APAC Point of Contact), Lean Six Sigma Management System Director, ALICO Japan Post M&A, Regulatory Affairs, Lean/Sigma QMS ISO, Private Equity M&A, OIG Remediation, and PMO Regulatory Affairs/Change Management/Design Thinking/Lean Six Sigma MBB.

Their expertise extends to areas such as global alliance management, liaison, GMP, compliance, process optimization, lean and agile methodologies, ISO standards, and regulatory affairs. Mr. Orlanes has played a pivotal role in delivering results and driving continuous improvement in their respective organizations.

Jun Edo Orlanes has a diverse education history with a focus on business administration, healthcare, and various other fields of study.

Jun started their education at UCLA, where they pursued a Bachelor of Science (BSc) degree in Anthropology & Molecular Cell Biology, with a specific focus on genomic/mRNA/tRNA/snRNA/UTR/Telomere/Centromere/Translation.

They later attended the University of Maryland - Robert H. Smith School of Business for an Executive MBA degree. Their studies in this program concentrated on Strategy-Operations, Healthcare Administration/Management, Finance, and Accounting.

Jun also studied at Waseda University, where they completed the School of International Liberal Studies, focusing on Economics, Politics, Society, Culture, and Japanese Language.

Furthermore, they pursued Japanese Language Studies at Sophia University through the JPLT Program.

Jun also engaged in Visiting Research at Kanda University of International Studies, studying Aesthetics of Culture & Music.

To enhance their expertise in Lean Six Sigma methodology and process improvement, Jun completed a Certification Program at Villanova University, earning a Lean Six Sigma Master Black Belt Certification (ISO 9001:2008: ASQ Methodology) and a Lean Six Sigma Black Belt Certification (ISO 9001:2008: ASQ Methodology).

They also obtained certifications from the Institute for Healthcare Improvement (IHI) and the Kaiser Permanente School of Allied Health Sciences (KPSAHS) in Project Management Professional (PMP) and PMI Foundational Certifications.

Jun further expanded their education by enrolling in various certification programs. They completed the IHI Improvement Advisor Certification Program and obtained a Comprehensive Unit Based Safety Program Certification (CUSP) from the Agency for Healthcare Research and Quality (AHRQ).

Additionally, they pursued the Project Management Professional Certification Program (PMP-PMI PMBOK) at the University of California, Berkeley.

Jun earned a Master of Public Health (MPH) degree from the UCLA Fielding School of Public Health, specializing in Community Health Science, Health Policy, International Health, Maternal-Child Health, and Epidemiology.

Continuing their academic journey, Jun is currently pursuing a PhD in Business Administration & Management at The University of Manchester, School of Business Doctoral College.

Furthermore, Jun participated in a High School Internship through an International Exchange Program at Universidad de Guadalajara.

In addition to their formal education, Jun has completed various executive seminars and programs. They have obtained certificates in Design Thinking: Customer Experience from Lynda.com, as well as completed executive seminars in Financial Management & Accounting, Strategic Human Resources, Entrepreneurial Marketing, and Practical Leadership from MIT Sloan School of Management. They also completed executive seminars in Essential of Microeconomics, Applied Economics for Managers, Strategic Management, and Consulting from the University of California, Berkeley, Haas School of Business. Jun further enrolled in seminars on Entrepreneurship & Power and Negotiations at UCLA Anderson School of Management.

Overall, Jun's education encompasses a wide range of disciplines, including business administration, healthcare, economics, culture, and language studies, providing them with a diverse skill set and knowledge base.

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Timeline

  • Global Alliance Director, Liaison, GMP, CMO/API Tech Transfer Remediation, FDA PAI, OpEx

    July, 2018 - present

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