Leading and Leadership in Lean Bio-Manufacturing Operations

Leading and Leadership in Lean Bio-Manufacturing Operations

  • Lean applications in Bio-Manufacturing is both complex and simple
    Sustaining lean performances in Bio-Manufacturing is both science and art
    Good versus Great Lean leadership… It matters
    Successful OE polynomial equation for Lean Bio-Manufacturing = … ?

Jacks Lee is an industry executive with global experiences in biopharmaceutical, small molecule drugs and vaccines. His 25+ years of experiences spans across technical, operational and strategic leadership roles in Science-Technology, Engineering, Quality, Supply Chain and Manufacturing. He currently serves as the Senior Vice President of Merck Manufacturing Division-Global Vaccines Operations. Jacks joined Merck in 2007 as head of Global Technology & Engineering. Prior to that, he was with Sanofi and its predecessor companies in varying capacities including serving as heads of US Biological Operations and Global Pharmaceutical Products Division. He is a member of the Vaccines Advisory Board, and was previously nominated and served on the United States Pharmacopia (USP) Expert Committee of Biostatistics.

Panel: Disrupting the Biotech Industry- How Small & Mid-Sized Innovators Create a Competitive Advantage

Panel: Disrupting the Biotech Industry- How Small & Mid-Sized Innovators Create a Competitive Advantage

  • Advantages of smaller more agile organizations’ ability to react to patient, regulatory & market pressures
  • Discussing internal innovations in production technologies and working with external partners to do the same
  • How do we adapt our leadership, organizational structure and people management strategies?
  • Lean implementations as a Smart Risk management tool
  • Leveraging collaborations with big pharma to foster innovation and increase speed to market


Alison Moore is Senior Vice President, Process Development for Amgen serving both Operations and R&D organizations. She has held a number of senior roles within Amgen overseeing operations technology, process and product engineering , and corporate manufacturing where she oversaw supply chain, contract manufacturing, global distribution, manufacturing technologies, and operations risk management. She also headed up Amgen’s Fremont, California, manufacturing facility (AFR). Before heading up the AFR facility, Moore was a director in chemistry, manufacturing and controls regulatory affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the process development organization. Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England.


Tina M. Larson is Vice President of Technical Operations at Achaogen, a biopharmaceutical company committed to the discovery, development, and commercialization of novel antibacterials to treat multi-drug resistant gram-negative infections. Ms. Larson is accountable for Process Development, Manufacturing, Supply Chain, Quality Assurance and In Vitro Diagnostic Devices. Prior to Achaogen, she was at Genentech/Roche for 20 years where she was involved in every commercial biologic product launched by Genentech through roles of increasing responsibility in Automation Engineering, Manufacturing Science and Technology, Process Development, and Global Business Operations. Ms. Larson was a member of both Genentech’s and Roche’s Technical Development leadership teams, leading functions in the U.S. and Europe. She was recognized nationally in 2012 as a Healthcare Businesswomen’s Association (HBA) Rising Star. Ms. Larson received her B.S. in Chemical Engineering from Colorado State University.

Ashraf AmanullahVP of Biologics Development and Manufacturing of aTyr Pharma, is a drug development and manufacturing executive with more than 20 years of demonstrated leadership experience in global pharma and biotechnology organizations, with expertise in process development, technical operations, cGMP clinical manufacturing, commercialization and life cycle management of antibody therapeutics, vaccines, gene therapy, cell-based therapeutics and recombinant proteins. Prior to joining aTyr Pharma, Ashraf was Senior Director at Gilead Sciences where he built a world class CMC organization, Director of CMC Development at Genentech. Prior to Genentech, Ashraf held various positions at Merck & Co. Inc. over nine year tenure, with responsibility for process development, cGMP manufacturing, and technology transfer and commercialization of vaccines. He is the author of 55 peer-reviewed publications, and his work has been presented at over 90 conferences. Ashraf received his Ph.D. in Chemical Engineering from The University of Birmingham (UK) and conducted post-doctoral studies with The University of Birmingham, Novo Nordisk, Merck & Co. Inc. and University College London.

Mayo Pujols is currently VP Global Head Car-T Operations and Technology at Celgene located in Summit, New Jersey. Prior to Celgene, he was the SVP of Technical Operations at Advaxis, Inc., a clinical-stage biotechnology company located in Princeton, New Jersey. He leads a team responsible for manufacturing, quality operations, process/analytical development, engineering, supply chain/logistics, and project management. Prior to this role, he was Advaxis’s VP of Technical Operations. Prior to that role he was Executive Director of Technical Operations at Merck supporting the vaccines and biologics franchises. Mayo has also worked in a number of other global and domestic roles throughout his career, including the areas of technology transfer, new product launches, validation, regulatory submissions/inspections, commercial/clinical manufacturing, and quality assurance/systems at Astra-Zeneca (MedImmune), Schering-Plough, and Merck.

Heidi Hoffmann, Senior Director, Supply Chain and CMC Team Lead of Sutro Biopharma, has 22 years of experience in biotechnology, specializing in process development, technology transfer, and manufacturing of vaccines and biological therapeutics. She began her career at Aviron working on vaccines for EBV, PIV, and influenza (FluMist®). She then joined Valentis, where she led the team responsible for process development, technology transfer, and clinical production of plasmid DNA for gene therapy. Dr. Hoffmann returned to vaccine work by joining VaxGen, working on process development and manufacturing of anthrax vaccine. Later, she transitioned into a technology transfer role, hiring and leading the VaxGen oversight team for the successful transfer of production of Bristol-Meyer Squibb’s Orencia® (abatacept) into the Celltrion manufacturing facility in South Korea. Dr. Hoffmann joined Sutro in February, 2011 and currently heads CMC and directs outsourced cGMP manufacturing for protein therapeutics and ADCs.


Panel: Looking Forward – Where are Biopharmaceutical Manufacturers Going, and How Should We Get There?

  • Talking about the state of the biotech industry today: Which emerging trend will see the most growth?
  • People and technology: How are these forces working together to grow and mature our industry?
  • Discussing challenges in capacity planning, make-buy decisions, and supply chain management
  • What is the next big challenge and the next big opportunity facing our community? Are we ready for it?


Patrick Yang, Former EVP, Technical Operations, Genentech

Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management functions in General Electric, Merck, Genentech and Roche. He was Executive Vice President and Global Head of Roche Pharmaceuticals Technical Operations based in Basel, Switzerland from January 2010 to March 2013. In this role, he was accountable for Roche’s pharmaceutical and biotech manufacturing operations, and process development. He and as previously Executive Vice President of Product Operations of Genentech, based in South San Francisco. Dr. Yang worked for Genentech for 10 years, from 2003 until his retirement in October 2013. Prior to joining Genentech, Dr. Yang spent 11 years at Merck & Co. in various leadership positions including Vice President, Supply Chain Management, and Vice President, Asia/Pacific Operations. Before joining Merck in 1992, Dr. Yang spent 12 years at General Electric (1980-1992), serving in research, engineering, technology, and manufacturing leadership roles with increasing scope of responsibilities. Dr. Yang holds a Ph.D. degree in engineering from Ohio State University, Columbus, Ohio. He a member of Board of Directors of Tesoro Corporation, Codexis, Celladon, Amyris, and PharmaEssentia.


Joanne Beck, EVP Global Pharmaceutical Development & Operations, Celgene Corporation

Dr. Joanne Beck is EVP Global Pharmaceutical Development and Operations at Celgene where she oversees the company’s Pharmaceutical Development, Global Manufacturing Operations, Engineering and Quality. Prior to Celgene, she was SVP of Pharmaceutical Development at Shire. Prior to Shire she held roles of increasing responsibility in Process Development at Genentech and Amgen and in Operations at Abbott’s Pharmaceutical and Vascular Divisions. Beck holds a BA in Chemistry from Lewis and Clark College, a Ph.D. in Biochemistry and Molecular Biology from University of Oregon Medical School, and completed a postdoctoral fellowship in the department of Pharmaceutical Chemistry at the University of California, San Francisco.

Sally Dyer, Director of Manufacturing for the Boulder Manufacturing Center, MedImmune

Sally Dyer joined AstraZeneca/MedImmune in 2016 as the Director of Manufacturing for the Boulder Manufacturing Center. In her current role, Sally is accountable to build and prepare the manufacturing organization for the introduction and on-going production of biologics for the newly acquired site. Prior to joining AstraZeneca/MedImmune, Sally spent time at Amgen, Inc. in various site and global manufacturing roles including site start-ups in Colorado, Puerto Rico and most recently at Amgen’s Next Generation manufacturing plant in Singapore. Sally holds a B.S. Degree in Biological Science with an emphasis in Molecular Cell Biology from the University of California at Davis.

Andrew Mica, Sr. Director, Global Supply Chain, NA Commercial Supply, Biogen

Andrew Mica is the Senior Director, North America Supply Chain at Biogen overseeing product lifecycle management, manufacturing planning and logistics, and commercial product distribution centers. He is directing new product launch and network strategy initiatives including a global assessment of Biogen’s distribution network and operating model aimed at modernizing current capabilities and preparing for the future portfolio. Prior to joining Biogen in 2014, Andrew worked with Amgen, in various commercial and clinical supply chain roles with leadership roles in Commercial Supply Chain organizational transformation and Supply Chain Segmentation initiatives. Andrew began his career with GSK in plant support, process improvement and new product introduction roles both domestically and abroad. Andrew served in the US Marine Corps, has a Bachelor of Science degree in Environmental Engineering from North Carolina State University and an MBA from California State University. He is a licensed Professional Engineer and certified Lean Six Sigma Master Black Belt.

Ken Green, Head of Manufacturing Science and Technology, Shire

Head of MS&T function at Shire with responsibility for commercial product technical support and CMC lifecycle activities. Over 18 years’ experience in the Biotech/Pharma industry with previous roles at Pfizer, Amgen, Lonza and GSK supporting manufacturing supply networks, biologics product commercialization and post-approval lifecycle management. Experience with process development, process characterization (QbD), validation, technology transfer and commercial manufacturing. I have a passion for continuous improvement with application of six and lean sigma methodologies and strategic deployment. In addition, I also enjoy leading high performing teams and a trained facilitator and innovation coach.