A live interview with the former Alpine Formula 1 CEO on Peak Performance Leadership
The 2024 TechOps Leadership Accelerator Program Highlights and Key Learnings
2025 TechOps Leadership Accelerator Program Launch
Tina Self is a dynamic leader with over 20 years of experience in the biotech and pharmaceutical industries, specializing in quality and manufacturing. Currently, she serves as the Senior Vice President of Global Biologics Manufacturing and Berkeley Site Head at Bayer. Tina has been with Bayer for over eight years, where she has held several key leadership roles, including Vice President of Manufacturing Operations and Vice President of Quality. She is recognized for her strategic oversight of manufacturing processes, commitment to quality assurance, and her ability to drive continuous improvement. Tina holds an MS in Biotechnology from The Johns Hopkins University and an MBA in International Business from Florida Atlantic University.
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Assessing Changes in the CMC Ecosystem: Are We Overbuilding Capacity Again?
Uniting for Success: Strategies to Prevent Fragmentation and Foster Collaboration in Biomanufacturing
Pioneering New Ventures: Reasons to Establish a New Company Today and Anticipating Future Growth in the Business Ecosystem
Evaluating Production Platforms for Emerging Modalities: Which Platforms Will Best Serve the Future of Medicine?
Navigating the Future of Existing Platforms: Efficiently Addressing Market Needs for Established Therapies such as mAbs, ADCs, and mRNA-based Treatments
Discussing the most important new technologies in biomanufacturing today, with a special emphasis on what we want to do as our industry matures
Debating how talent and workforce development in our industry is changing, and what we should do about it
Listing the current factors affecting speed of development and efficient manufacturing. How do we continue to improve in a changing business landscape with special reference to IRA and the BIOSECURE Acts?
Understanding the current Regulatory environment with an eye for how things are going to evolve into the future
How can we improve the access of biologic medicines?
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.
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Science outpacing Industrialization of Technology: Reviewing next generation cell and gene therapy platforms/technologies, gene editing technologies to unlock new possibilities.
Manufacturing to Scale: Scaling up to meet demand, comparability challenges, production capacity, AI tools and AAV production will drive speed to market/approval
Regulatory Evolution: evolving regulatory frameworks and innovative products necessitate industry and local and global regulatory collaboration to define efficient pathways to approval
Economic/Global Expansion: expanding access to ATMP’s in new regions, reducing cost of goods via production efficiency, expanding global infrastructure to facilitate access to new patients
C. Greg Guyer, Ph.D, joined BioMarin in May 2020 and currently serves as Chief Technical Officer and Executive Vice President of Global Manufacturing and Technical Operations, responsible for overseeing our manufacturing, process development, quality, supply chain, engineering and analytical chemistry departments. From 2015 to 2019, Dr. Guyer served in a number of increasingly responsible positions at Bristol Myers Squibb (BMS), primarily leading all of operations and biologic development. Prior to BMS, Dr. Guyer worked for Merck & Co., Inc., from 1994 to 2015, leading various global organizations in biologic and pharmaceutical operations, quality, regulatory, emerging markets strategy and enterprise systems. He currently serves on the Board of Directors for the University of Georgia Research Foundation.
Dr. Guyer earned his Ph.D. in analytical chemistry from American University, Bachelor of Science degree in chemistry from the University of Georgia and Master of Business Administration degree from Lehigh University
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Dr Mire-Sluis is currently Head of Global Quality at AstraZeneca. He was previously Vice President, North America, Contract, Singapore and Product Quality at Amgen Inc. Prior to working at Amgen, he was Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego.
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Jamie Moore is currently Senior Vice President of Technical Development responsible for the CMC development of drug substance and drug product for Gilead’s pharmaceutical and biologic product portfolio. She has over 20 years of experience as a chemist and pharmaceutical scientist working in both large and small Biopharmaceutical companies including CytomX and Roche. At CytomX, she was Senior Vice President on the executive team leading the Protein and Process Sciences, and Manufacturing organizations. Previously she spent a significant portion of her career at Genentech/Roche where she held multiple technical and managerial leadership roles within Pharma Technical Operations including Head of Pharmaceutical Development and Global Head of Manufacturing Science and Technology for Commercial Products. Externally, Jamie is serving as the President- for the Board of Directors for CASSS, an organization that brings together industry, academic and regulatory leaders to resolve scientific challenges impacting CMC development and regulation. She has a B.S. in Chemistry and received her doctoral degree in Chemistry and Chemical Biology from UCSF.
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Søren Thuesen Pedersen is Senior Director, External Affairs, Regulatory Policy and Intelligence at Novo Nordisk. He is a Chemical Engineer by education and has been working 30 years in Novo Nordisk. During that that time he has been engaged and lead different areas within Manufacturing, QC-Laboratory and CMC Manufacturing Development. He has been one of the founding fathers of the Novo Nordisk External Requirements’ Process; How does Novo Nordisk ensure compliance of new external requirements? Mr. Pedersen is currently responsible for the External Representation and Advocacy strategy out of Novo Nordisk’s GMP&Q area and represents Novo Nordisk in various associations ISPE, EFPIA, IFPMA and BIO. Specifically, Mr. Pedersen is a member of the EFPIA Manufacturing Quality Expert Group (MQEG) since 2019 and member of the Board of Directors in IQ Consortium.
He has furthermore been member of the Novo Nordisk Board of Directors for 12 years as an elected employee representative.
His spare time interests include Danish and EU Politics.
Martin P. Müller joined Novo Nordisk in 2014 and currently directs development projects for innovative technologies within Aseptic Manufacturing, with particular focus on formulation, filling, wash & sterilization, and environmental monitoring.
Before moving to production in Novo Nordisk, Mr. Müller has served 10 years in Device R&D, driving the digital agenda of the area, external affairs and QMS-processes and project management, among others.
Mr. Müller earned his Master of Arts from Humboldt University Berlin, Germany, and his Master of Business Administration from Copenhagen Business School, Denmark.
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Thomas has been serving as the Senior Vice President of Cell Therapy Development and Operations at BMS since August 2023. Before joining BMS, he held multiple roles with Merck & Co, where he gained experience in basic research, early and late-stage process development, capital project management, site-based technical operations, commercialization, manufacturing science and technology, and supply chain. Before that, Thomas worked for startup, GlycoFi, founded at Dartmouth College, where he conducted post-doctoral research after receiving his PhD in Bioprocess Engineering from the University of Cape Town in South Africa.
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In his current role as the Senior Director of Validation at Spark, John leverages over 24 years of expertise in the compliance and validation of enterprise computer systems, applications, and equipment regulated by the FDA and EU. John is a compliance and validation thought leader and has a deep understanding of 21 CFR Parts 210, 211, 606, 820, 11, and Annex 11. John’s experience spans a variety of analytical systems, including HPLCs and spectrophotometers, as well as computer systems such as ERP, LIMS, EDMS, EMS, PCS, and DCS, serving major pharmaceutical, medical device, and blood management companies. Before joining Spark in May of 2015, his career included roles at Pfizer, AstraZeneca, TEVA, Smith & Nephew, GE Healthcare, DSM, Haemonetics, and the American Red Cross, where he has consistently ensured compliance with predicate rules, 21 CFR Part 11, and GAMP 5 guidance. John holds a Bachelor of Science degree in Computer Information Systems from the Florida Institute of Technology.
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John Pinion has over 30 years of global biotech leadership experience across multiple modalities, including gene therapy, and spanning multiple functions across CMC and translational sciences.
John joined Ultragenyx in July 2015 and provides leadership for Quality, Compliance and Translational Sciences to include Pharmacology, Toxicology, Research and Bioanalytical Development. As an executive leader, he contributes to corporate strategy and portfolio management.
Prior to joining Ultragenyx, Mr. Pinion held senior leadership roles at Roche and Genentech departing the organization as Senior Vice President, Global Head of Quality and Compliance. Prior to Genentech, Mr. Pinion spent 17 years in operational and global senior leadership roles at Baxter International.
In addition to his position at Ultragenyx, John is currently COO of Amlogenyx, a subsidiary of Ultragenyx and is a member of the Board of Directors of Aroa Biosurgery Ltd.
He holds a B.S. in Mechanical Engineering from West Virginia University.
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Andrew “Andy” Ramelmeier, Ph.D. is Adverum’s chief technology officer responsible for leading the company’s technology and operations organization, including process development and manufacturing. Dr. Ramelmeier has more than 30 years of experience in the development and manufacturing of biopharmaceuticals, including monoclonal antibodies, vaccines, gene and cell therapy products and therapeutic proteins. Most recently, Dr. Ramelmeier served as executive vice president, head of technical operations at Sangamo Therapeutics, where he was responsible for quality, process and analytical development, manufacturing and supply chain of viral vector and cell therapy pipeline products, as well as the oversight of two internal GMP facilities and multiple contract manufacturing organizations (CMOs)/contract research organizations (CROs) for manufacturing and quality control (QC) activities. Prior to Sangamo, Dr. Ramelmeier served as senior vice president, technical operations at Portola Pharmaceuticals, responsible for the process development, technology transfer, manufacturing, and supply chain of small and large molecule pipeline products. Before that, Dr. Ramelmeier held positions of increasing responsibility at several companies, including BioMarin Pharmaceuticals, Johnson & Johnson and Merck Research Laboratories.
Dr. Ramelmeier earned his B.E.S. in Chemical Engineering from Johns Hopkins University and a Ph.D. in Chemical Engineering from University of California, Berkeley. He conducted post-doctoral work at The Institute of Enzyme Technology affiliated with the Heinrich-Heine-University of Dusseldorf.
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Karin Ann Payne is the Vice President of Corporate Quality in BMS.
In this role, Karin provides strategic quality and compliance leadership in the GxP development and implementation of an integrated QMS across the Enterprise including Research and Early development, Global Drug Development, Global Product and Supply and Medical Affairs and in support of the product lifecycle.
Prior to joining BMS she was the VP of NA Quality for Bayer where she was responsible for ensuring that Bayer remained committed to the highest standards of quality, which is paramount to the patients and customers it serves every day. She joins Bayer from Reckitt Benckiser, where she most recently held the role of Head of Global Corporate Quality Compliance. In this role, she was responsible for managing the company’s Global Quality Management System, Corporate Quality audits, and its Global metrics and Computer System Validations teams. She also managed the Europe and North America Commercial Quality teams, responsible for managing market quality. Prior to that, she held a variety of roles in Quality Assurance and Compliance including positions at Actavis and Pfizer, managing the unique challenges and opportunities of both the consumer health and pharmaceutical industries.
She holds an MLS in Pharmaceutical law (High Honors) from Seton Hall, MBA in Financial Management (High Honors) with a Certificate in International Finance from Iona University and a Bachelor’s in Biological Sciences from Rutgers University.
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Koustuv Chatterjee is the Senior Vice President of External Manufacturing & Supply, in the Manufacturing & Supply division of Sanofi. Prior to joining Sanofi in 2023, Koustuv has held several leadership positions in Merck & Co, Teva Biopharmaceuticals USA, and Amgen Inc. Koustuv’s career started in process development and has spanned across manufacturing operations, network strategy, product and device development, Manufacturing Science & Technology, internal and external manufacturing operations. Koustuv obtained his Bachelor’s degree in Pharmaceutical Technology from Jadavpur University, Kolkata, India, Masters. in Industrial Pharmacy from University of Toledo Ohio, and Ph.D. in Pharmaceutics from University of Minnesota.
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Kevin has over 20 years of biologics manufacturing experience for both innovators and CDMOs in all phases of molecule lifecycles. He currently leads Just’s innovative J.POD continuous manufacturing site in Redmond, WA.
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