Speakers

Edgardo Hernandez (he/him/his) is executive vice president at Eli Lilly and Company and president of manufacturing operations.

Ed served as senior vice president of global parenteral drug product, delivery devices and regional manufacturing from 2018 until 2021. In this role, he was responsible for global parenteral manufacturing, emerging markets manufacturing, drug-product contract manufacturing, packaging, and distribution operations. Ed provided oversight for manufacturing sites in 12 countries across North America, South America, Europe, and Asia; that manufacture the final parenteral product (non-oral) formulations of Lilly medicines.

Previously, Ed was vice president of Fegersheim Operations for Lilly’s manufacturing site located in France. Before that, he served as site head for two other Lilly manufacturing sites: Indianapolis Active Pharmaceutical Ingredient manufacturing from 2014 until 2016, and PR06 in Puerto Rico from 2012 until 2014. Ed joined Lilly in 2005 as an engineering services leader for Lilly del Caribe in Puerto Rico, after working for several years in positions for Pfizer and Pharmacia.

Ed is a native of Puerto Rico and holds bachelor’s and master’s degrees in chemical engineering from the University of Puerto Rico and North Carolina State University, respectively.

Laura Alquist joined Kite in 2016 and currently serves as Vice President and Global Head of Technical Operations.

She has more than 25 years of experience in all aspects of technical operations including manufacturing, supply chain, quality and information systems. Laura served as Vice President of Global Supply Chain at Kite before being named Global Head of Manufacturing in 2023. Under her leadership, Kite’s manufacturing team has improved its industry-leading track record for reliability and speed. Additionally, Laura successfully led the team in navigating the COVID-19 pandemic with zero supply disruptions to the patients and providers who rely on Kite’s therapies. Before joining Kite, Laura spent 20 years at Amgen in a range of global and operational roles of increasing responsibility across supply chain, manufacturing, quality and IT.

Laura holds a bachelor’s degree in business management from California Lutheran University and is APICS certified in supply chain operations.

Dr. Advant has served as Savara’s Executive Vice President, Global Technical Operations since March 2024. With approximately three decades of experience in the biopharmaceutical sector, he has considerable expertise in drug substance, drug product, and analytical development with early- and late-stage clinical and commercially approved biologics. Dr. Advant also has extensive expertise in technology transfer, scale-up and cGMP manufacturing (both internal and external) in a highly regulated environment. To date, Dr. Advant has helped launch multiple biologic assets across several therapeutic areas. Prior to joining Savara, he was VP, Manufacturing Operations at GSK, where he was responsible for multi-site drug substance and drug product operations. Previously he held roles of increasing responsibility at Celgene Corporation (acquired by Bristol Myers Squibb), Kemwell BioPharma, ImClone/Lilly, and Diosynth Biotechnology (now FujiFilm Diosynth Biotechnolgy), among others. Dr. Advant holds a Ph.D. in Pharmaceutics from the University of Connecticut.

Dr. Pat Yang is one of the most accomplished biotech manufacturing executives and technical operations leaders in the industry.

From 2017 to 2019, Pat was executive vice president at Juno Therapeutics, a leading CAR-T biotech company (now part of BMS) based in Seattle.

Previously, from 2009 to 2013, Pat was Executive Vice President and Global Head of Technical Operations at F. Hoffman-La Roche based in Basel, Switzerland. In this role, he was responsible for Roche’s biopharma process research and development, analytical sciences, engineering, quality, technical regulatory, supply chain and all manufacturing plants with approximately 15,000 employees around the world. From 2003 to 2009, Pat was Executive Vice President of Product Operations at Genentech. He assumed his role as Global Head of the combined technical operations of Roche and Genentech upon the acquisition of Genentech by Roche in 2009.

Before Genentech, Pat worked for 11 years at Merck & Company from 1992 to 2003, based in New Jersey, in various leadership positions including vice president of Asia Pacific Operations and vice president of Global Supply Chain Management. Prior to joining Merck in 1992, Pat spent 12 years at General Electric, serving in research, engineering, technology, and manufacturing leadership roles with increasing scope of responsibilities.

Pat holds a Bachelor of Science from the National Chiaotung University in Taiwan, a Master of Science from the University of Cincinnati, and a Ph.D. in engineering from Ohio State University.

Pat is a member of the Board of Directors of three public companies, Amyris, Codexis and PharmaEssentia. In addition, he is on the board of several private companies, including Acepodia, AltruBio, Antheia and Sana Biotechnology.

Brendan O’Callaghan leads Sanofi’s Manufacturing and Supply organization, a global network of close to 40 internal manufacturing sites, supported by a network of strategic external supply partners. Sanofi’s ambition is to build an Industry leading manufacturing and supply chain capability, based on a future-ready organization and network that will ensure the flawless launch of Sanofi’s rich and diverse late-stage pipeline and the continued, reliable supply of essential, high-quality, affordable and sustainable medicines and vaccines for patients, worldwide. Sanofi will leverage the latest in scientific, digital, technology and workforce solutions to achieve this ambition.

Brendan joined Sanofi in 2015 as Global Head of Biologics, later taking leadership of the integrated Manufacturing and Supply network supporting our Specialty Care portfolio, prior to taking on his current responsibilities in September 2021. He has played a key role in enabling Sanofi’s transformation to a fully integrated BioPharma company and advancing the modernization and digital transformation of our manufacturing teams and network, building capabilities and capacities to support Sanofi’s growth in Biologics, Vaccines and Small Molecule Manufacturing, as highlighted by continued investments into state of the art, digitally advanced and future ready facilities such as the 2020 ISPE Facility of the Year award winning site in Framingham, MA and Sanofi’s agile and industry leading Modulus platforms in Neuville (FR) and Singapore.

Prior to Sanofi, Brendan worked with Merck / MSD, Mallinckrodt and Schering-Plough, where he led Tech Ops organizations of increasing scope and responsibility, across a variety of site and global leadership roles.

Brendan graduated in Chemical Engineering from the University College of Dublin, where he currently serves as an honorary adjunct Professor of Chemical and Biochemical Engineering.

He is married with four sons. A keen sports enthusiast, Brendan is a UEFA qualified soccer coach.

Sanat Chattopadhyay is responsible for the company’s (approx.  $64 billion revenue) worldwide manufacturing and supply operations across a global network of sites for pharmaceuticals, vaccines, biologics and animal health products. Merck is known as MSD outside of the U.S. and Canada.

Sanat joined Merck in 2009 as Senior Vice President of Global Vaccines & Sterile Manufacturing Operations, spearheading the transformation of manufacturing and supply chain to grow and globalize its Vaccine business. Under Sanat’s leadership, Merck is currently executing a significant expansion of its biologics and vaccines manufacturing capacity with planned capital investments of more than $20 billion from 2020 through the end of 2024, to reach more patients around the globe.

Before joining Merck, he served as Senior Vice President, Technical Operations & Product Supply, for Wyeth Pharmaceuticals. Previously, he worked at Aventis and its predecessor companies as Senior Vice President, Industrial Operations, having served in many positions with increasing responsibilities for global supply chain, technology and manufacturing sites across North America, Europe and Asia Pacific. Sanat started his career with Hoechst Pharmaceuticals in 1983 and worked in many senior leadership assignments.

Sanat is a graduate in Chemical Engineering and holds a post-graduate degree in Industrial Engineering from India.

Outside of Merck, Sanat is a member of the Board of Directors of Ashland Inc.

Susan Abu-Absi, Ph.D. is a strategic operations executive with over 20 years of experience in product development and supply in the biopharmaceutical industry. She joined Be Bio in March 2025 as Chief Operating Officer, responsible for driving all operational aspects of the business to unleash the power of engineered B cell medicines as therapeutics for patients with serious diseases.

Prior to Be Bio, Susan was Chief Technology Officer at 2seventy bio where she led the Technical Development, Supply & Quality organization. Her team provided deep execution capabilities in autologous cell therapy manufacturing resulting in the launch of Abecma and the translation of four novel therapies with complex layered technologies into the clinic.

Prior to 2seventy bio, Susan led technical development & operations at bluebird bio, a pioneer in ex vivo gene therapies, where she played an integral role in the approvals of Zynteglo and Skysona.

Prior to joining bluebird, Susan held leadership roles in the Global Product Development and Supply organization at Bristol Myers Squibb. She started her career in the Process Sciences organization at Bayer Healthcare.

Susan earned a Ph.D. in Chemical Engineering from the University of Minnesota, where she conducted research in the laboratory of Professor Wei-Shou Hu as a National Science Foundation Fellow, and a B.S. in Chemical Engineering, Summa Cum Laude with Honors, from the University of Toledo.

Andrea (Andi) Goddard serves as Chief Technical Officer at CatalYm. She brings three decades of global biotechnology experience, spanning all levels of operations — from the manufacturing floor to the C-suite. Andi joined CatalYm from Roche Pharma and Genentech, Inc. where she most recently was the Chief Quality Officer for Roche Pharma Technical Operations. In this role, she led a global team delivering end-to-end quality and compliance for Roche’s pharmaceutical commercial products and clinical pipeline. During this time, Andi was also a member of the Genentech, Inc. Executive Committee. Previously, Andi held various operational and executive roles in manufacturing, technology, and quality across Roche and Genentech. Andi holds a BA in Human Biology from Stanford University.

Stephen Hill is the Chief Operating Officer at Lyell. He is responsible for research and end-to-end development and supply of cell therapies to support Lyell’s clinical and commercial aspirations.

Hill was formerly Head of Biologic Operations at AstraZeneca where he was responsible for end-to-end supply of the commercial and late-stage clinical portfolio for Biologics that included oversight of six manufacturing sites across the US and Europe and five commercial products.

As Vice President Operations, Site Head at the AstraZeneca Frederick Manufacturing Center, Hill was responsible for the largest biologics manufacturing facility within the company’s global network. The site consists of a licensed, large-scale cell culture facility and recently commissioned small-scale facility.

Prior to AstraZeneca Hill served as Vice President Bulk Manufacturing at Amgen’s Puerto Rico facility and as Executive Director leading commercial formulation and filling and commercial drug substance operations.

Hill also served prior roles as Executive Director, Manufacturing Technologies leading manufacturing global networks and as Executive Director, Plant Manager leading clinical drug substance operations. In his corporate role he led manufacturing of the future, operations strategy, high reliability performance and manufacturing global network initiatives. In his plant manager role he was an effective change agent driving productivity improvement to deliver multiple pipeline new product introductions annually.

Hill joined Amgen from ICOS Corporation where he executed GMP clinical plant start-up and led manufacturing, ultimately transitioning the operation into a contract manufacturing business. Hill started his career at Immunex Corporation as an operator manufacturing Enbrel.

Hill holds a Master in Business Administration (MBA) and Bachelor’s in Microbiology (BS) and Political Science (BA) from the University of Washington.

Aine’s career in the biomanufacturing sector spans roles in the UK, Ireland, and the US, with a strong focus on developing innovative solutions to expedite the delivery of medicines to patients. Aine Hanly has recently rejoined Amgen as Vice President, Quality. In this role, Aine will lead a global team accountable for all aspects of quality oversight for Amgen’s products, from early product and process design to manufacturing and product supply to ensure that quality standards are met and in compliance with applicable regulatory requirements.

Prior to her return to Amgen, Aine spent the past 4 years with Vir Biotechnology, an immunology-based biopharmaceutical company developing medicines for infectious diseases and other serious conditions. Aine was the Chief Technology Officer (CTO) and EVP Technical Operations, leading the company’s technical operations function, which included responsibility for end-to end GxP Quality and Data Strategy.

Prior to Vir, in her almost decade-long tenure at Amgen, Aine led teams across several Amgen sites (ACO, AML, AMA and ATO) including oversight of clinical manufacturing and clinical supply (MCS). Her leadership roles in Process development supported the commercialization of Amgen’s pipeline products and technical support for ongoing manufacturing operations. As the site head at Amgen’s Cambridge facility, Aine also led the site’s transformation and staff expansion.

Prior to joining Amgen in 2012, Aine held roles of increasing responsibility in Pfizer (formerly Wyeth) Process Development, Product Supply and Quality including site head of Quality for Pfizer’s Grange Castle Manufacturing site in Ireland.

Aine earned her bachelor’s degree in biological chemistry and her Ph.D. in physical organic chemistry from the University of Ulster in Northern Ireland. She completed her post-doctoral fellowship at Creighton University School of Medicine before joining Yale University and CuraGen Corporation as a lead scientist, where she focused on gene isolation and validation using various molecular biology techniques.

Pascal leads Russell Reynolds’ operations in New York and Canada. He works closely with our healthcare clients around the globe, advising them on their talent strategy, including leadership assessment, succession planning, and the recruitment of directors, CEOs, and other senior executives.

Within the healthcare industry, Pascal specializes in biotech and pharma technical operations, including process development, manufacturing, quality, engineering, and supply chain leadership.

Pascal received his Bachelor of Engineering Physics degree from the Royal Military College of Canada and trained as an aerospace engineer with the Royal Canadian Air Force. He also earned master’s and doctorate degrees in business administration from Athabasca University in Canada, where he focused his research and dissertation on CEO succession. Pascal speaks fluent French and English.

SVP, Head of Global CMC at WuXi Biologics. Reporting directly to Dr. Chris Chen, CEO, leads the CMC function with responsibility for the overall CMC teams’ project delivery and key account management.

Prior to joining WuXi Biologics, Nuno was the SVP, Head of Biologics Development at Bayer Pharmaceuticals, member of the Pharmaceutical Supply Biotech Senior Leadership Team, responsible for all process development and clinical manufacturing of all cell therapy, gene therapy and recombinant protein therapeutics in both Berkeley, CA, USA and in Wuppertal, Germany.

Prior to joining Bayer in January 2021, Nuno was the Executive Vice-President of Technical Development at Coherus Biosciences, Redwood City, (Silicon Valley) CA, USA, member of the Executive Committee, reporting directly to the CEO and accountable for Process Development, Process Engineering, Tech-Transfer and Clinical Manufacturing (DS and DP) up to and including Process Validation/PPQ.

Prior to joining Coherus Nuno was Executive Director of Process Science (PD and Clinical MFG) at Boheringer-Ingelheim in Fremont CA where he worked for 7 years, and prior to that Nuno spent 9 years at Genentech (CMC Leader, group leader) and 4 years at a CDMO in Europe (Biotecnol SA.) as head of purification and analytical development.

Nuno has 20+ years of industrial experience in bioprocess development (cell line, cell culture, purification, analytical, formulation, drug substance and drug product) and GMP manufacturing of Biologics in both bacterial and mammalian expression systems. Vast experience in management, having led large groups (of up to 120p.), has been a member of executive and site leadership teams, reporting to CEOs and Site-Heads, responsible for large budgets, product portfolios, and strategic leadership of a wide range and scope of activities in all domains of Technical Development and Operations. During his career, Nuno, has significantly contributed to the clinical and commercial CMC development of more than 20 clinical products, 3 of which reached the commercial market.

Nuno is particularly passionate for technology innovation management, and in that context has led teams which made significant contributions to novel bioprocessing tools and techniques.

Nuno has a PhD in Biochemical Engineering, a Post-graduation (MBA equiv.) in Commercialization of Science and Technology, a Masters in Molecular Biology and an BSc. in Applied Chemistry.

A chemical engineer by training with a Ph.D. in Chemical Engineering from The Technical University of Denmark, Hanne Bak started at Regeneron in 2004 as a Research Engineer in Preclinical Manufacturing and Process Development (PMPD). First, Hanne enjoyed increasing levels of responsibility within PMPD while also developing an Analytical team providing high throughput analytical support to PMPD. In 2015, Hanne transitioned into overall leadership of the PMPD department. In this role, she was responsible for all aspects of process development ranging from
molecule and cell line assessment and selection through technology transfer and post launch process optimization activities. Since joining Regeneron, Hanne and her team have been involved in the development and technology transfer of well over 100 novel manufacturing processes for mAbs, bispecifics, Adeno Associated Virus (AAV), Antibody Drug Conjugates (ADC), and Antibody Tethered Ligand (ALT) to eleven different Regeneron manufacturing suites, provided subject matter expertise for technology transfers to external contract manufacturing and partner sites, and contributed to or fully developed manufacturing processes for all of Regeneron’s thirteen (13) approved pharmaceutical drugs. Hanne has also overseen the digital transformation of PMPD, including extensive laboratory, process and data automation efforts and data architecture. In 2025, Hanne expanded her role to lead a newly formed function named Product, Analytical, and Process Development (PAPD), encompassing all aspects of process development through drug product, including extended analytical characterization, assay and reagent development supporting Regeneron from research through commercial manufacturing. Hanne is also the executive sponsor for Regeneron’s LGBTQ+ employee user group and serves on Regeneron’s Responsibility Committee.

Dr. Yun Mao is an accomplished leader in the pharmaceutical industry with over two decades of experience. She currently holds the position of Vice President of Drug Product Development within Global Product Development and Supply (GPS) at Bristol Myers Squibb. Yun earned her Bachelor of Science in Chemistry from Peking University, China, followed by a Ph.D. in Analytical Chemistry from the University of Minnesota.

Her career began as a Senior Research Chemist at Merck & Co., after which she progressed through roles of increasing responsibility, including serving as Executive Director overseeing an analytical sciences organization dedicated to all aspects of drug substance analytical development. In 2018, Yun joined Celgene to manage the company’s alliance portfolio, subsequently expanding her scope to lead portfolio strategy and the integration group at BMS.

As head of Drug Product Development, Yun leads efforts to develop innovative and patient-centric products for all small molecules and biologics at BMS. Outside of her professional commitments, Yun has been married for 28 years and is the mother of twin sons who recently graduated from college. In her personal time, she enjoys spending time with her family and friends, as well as caring for her dog, Simba.

Rodrigo Muradas is Vice President and Head of R&D GMP Quality at Takeda, where he leads the company’s global GMP Quality organization supporting all programs under development including medical device and digital health across Takeda portfolio. He is recognized as an international leader in transforming Quality from a compliance function into a strategic enabler of innovation.

With more than 20 years of global leadership experience across North America, Europe, and Latin America, Rodrigo has led large-scale organizational transformations, supported groundbreaking therapies, including cell and gene therapies and guided organizations through complex regulatory approvals while advancing digital and AI-enabled quality capabilities.

Passionate about innovation, science, and digital transformation, Rodrigo is committed to helping organizations harness emerging technologies to improve decision-making, accelerate development, and ultimately deliver better outcomes for patients. He has completed executive education at Harvard Medical School, MIT Sloan, Yale School of Management, Duke University, and IMD Business School, with a focus on healthcare innovation, digital transformation, executive leadership, and organizational performance.

At the Biomanufacturing World Summit, Rodrigo will share his vision for how AI is transforming Quality into a strategic business partner accelerating innovation, strengthening risk-based decision-making, and enabling the next generation of biopharmaceutical development.

Nick Warne is currently Vice President of Pharmaceutical Research and Development at Pfizer.  Nick has 36 years of industrial experience focusing on biologics formulation development, dosage form design and manufacturing process development.  He and his team have been fortunate to have contributed to the licensure of 25 biologics including clotting factors, growth proteins, mabs, vaccines and ADCs.  Nick holds numerous protein formulation patents and, with his group, has made over 100 presentations at national meetings and in journals.  Prior to his position at Pfizer, Nick had positions of increasing responsibility at Wyeth and Genetics Institute, and has been based in Andover, Massachusetts.  Nick received his PhD in Chemistry from Purdue University under the guidance of Professor Michael Laskowski Jr. He received his BS in Biochemistry, with Distinction in Research, from the University of Rochester.

Kawa Chiu is the Chief Technical Officer of Abdera Therapeutics Inc. Kawa joined Abdera in 2022. She brings to Abdera more than 25 years of global manufacturing, supply chain and CMC experience across broad modalities.

Prior to Abdera, Kawa served as the vice president of CMC supply chain at Lyell Immunopharma, a cell therapy company focused on solid tumors. During her tenure, Kawa oversaw CMC programs that enabled three IND approvals, established the company’s autologous patient supply chain, and implemented a progressive cloud based, integrated manufacturing systems. Prior to Lyell, Kawa spent 14 years at Genentech in South San Francisco and at Roche in Basel, Switzerland in roles including head of Oceanside drug substance manufacturing, global head of technical operation strategy, global head of biologics operational excellence and global head of supply planning. Kawa started her career and held a number of manufacturing positions at Merck & Co., Inc.

Kawa holds a B.S. in operations from The Ohio State University, a M.Sc. in Engineering from University of Pennsylvania, an MBA from New York University, and a Master in Public Health from U.C. Berkeley.

Siegfried Hackl, PhD, is Senior Vice President of Product Supply at Ultragenyx, where he has led External Manufacturing and Global Supply Chain Management since February 2017. He is responsible
for clinical and commercial supply across gene therapy, small molecules, biologics, and nucleotide
modalities. In this role, Dr. Hackl develops and executes manufacturing strategies and oversees a
global CMO and distribution network to ensure a robust, responsive, and financially accountable
supply system. He also contributes significantly to CMC development across Ultragenyx’s diverse and
innovative product pipeline and plays a key role in shaping the company’s quality mindset and continuous improvement culture, while actively supporting talent development, workforce agility, and
inclusion and diversity.

Prior to joining Ultragenyx, Dr. Hackl spent more than two decades at Boehringer Ingelheim (1993–
2017), holding a variety of senior leadership roles across Europe and the Americas. His positions included Head of Microbial Fermentation (Austria), Head of a European Manufacturing Alliance Project
(Germany), Vice President of Fill & Finish for all biotech molecules (Germany), Plant Manager and
Vice President of the BI manufacturing site in Mexico, Head of Systems Quality Assurance for BI Germany, Global Head of Biotech Performance Management and Lean Transformation, and Head of
Lifecycle Management for a blockbuster respiratory device platform.

Dr. Hackl holds an MSc in Biotechnology from the University of Vienna and a PhD in Pharmaceutical
Technology from the University of Berlin.

Craig Beasley is the Chief Technical Officer at BlueRock Therapeutics. Prior to joining BlueRock, Craig was the Vice President, Cell Therapy Supply Chain at BMS, where he oversaw supply chain for BMS’s clinical and commercial stage cell therapy assets. Previously, Craig was Head of Manufacturing and Supply Chain at Juno Therapeutics and Vice President of Next Generation Manufacturing at Biogen. Prior to working in biotechnology, Craig worked for Union Carbide in process development. Craig holds a B.S. in Chemical Engineering from Purdue University.

Rakesh Kakkar serves as Head of Manufacturing & Supply, Vaccines, US at Sanofi, where he leads vaccine manufacturing operations for over 2000 Sanofian’s across US sites. In this pivotal role, he oversees a comprehensive portfolio spanning manufacturing operations for Drug Substance and Drug Product, Supply Chain, Quality, Strategy, Technical Services, Engineering, Project Management, and Operational Excellence. His leadership has been instrumental in driving Sanofi’s vaccine manufacturing capabilities and ensuring the delivery of life-saving vaccines around the globe.

With over 25 years of distinguished experience in the biotechnology industry, Rakesh brings deep expertise in vaccines and therapeutic oncology immunoconjugates. Prior to his current role, he served as Head of Biologics Manufacturing at Sanofi, managing Drug Substance Manufacturing at the Swiftwater site. Before joining Sanofi in 2016, he spent 16 years at Pfizer Biotech/Wyeth in roles of increasing responsibility, where he led vaccine manufacturing operations and successfully localized vaccine manufacturing in emerging markets in Turkey, Russia, Argentina & South Africa.  His strategic acumen encompasses CMO evaluations, manufacturing process transfers, quality systems implementation, regulatory strategy for product launches, and the deployment of new technologies to maximize operational efficiency.

Rakesh’s contributions extend beyond operational excellence to strategic partnerships and significant capital investments. He has collaborated extensively with HHS/BARDA on pandemic influenza vaccine projects, demonstrating his commitment to public health preparedness. Under his leadership, the expansion of Swiftwater sites has included the building and licensing of new facilities representing over $1.2 billion in investment. His regulatory expertise is evidenced by his extensive interactions with FDA, EMA, ANSM, PMDA and various global regulatory agencies, as well as his service on the USP expert panel.

Dr. Kakkar holds a Ph.D. in Biochemistry from Guru Nanak Dev University, India, and an M.S. in Clinical Pathology from the University of Saskatchewan, Canada, where he also completed Post-doctoral fellowship at the College of Medicine. He has authored more than 33 peer-reviewed publications and is an active member of ISPE. Additionally, he served as co-executive sponsor for Sanofi’s VETS Employee Business Resource Group through December 2025, reflecting his commitment to fostering an inclusive workplace culture. Rakesh’s strategic vision and operational leadership continue to advance Sanofi’s mission of protecting health and enabling access to vaccines for communities in the United States and across the globe.

Jose Torres-Vorshirm is Senior Vice President of Global Technical Operations at BioNTech, where he oversees the end-to-end technical operations supporting the company’s pipeline and operations. His responsibilities encompass advancing a broad range of modalities—including antibodies and mRNA-based therapeutics—through development, manufacturing scale-up, and commercialization.

With more than 25 years of leadership experience in biopharmaceutical technical operations, global supply chain, and manufacturing, Jose has built expertise in delivering complex biologics and advanced therapies at commercial scale. Prior to his current role at BioNTech, he served in leadership roles at AstraZeneca, Eli Lilly and Company, and Novavax.

Jose holds a Master’s degree in Technical Management from Johns Hopkins University, a Postgraduate degree in Business Management and Supply Chain from the University of Warwick in England, and a Bachelor’s degree from the University of Puerto Rico-Mayaguez. He is a recognized leader in driving technical operations strategy and execution to bring innovative therapies to patients.

Angela Jung specializes in recruiting transformational technology executives for global Fortune 500, private equity, venture capital, and growth-stage firms.

Based in New York, Angela is a leader in our global cybersecurity team and a member of our Technology Practice. She excels at recruiting Chief Information Officers, Chief Information Security Officers, Chief Technology Officers, Technology Operating Partners, and board directors. During her career, Angela has proven herself as a trusted advisor, delivering tailored leadership solutions to ensure her clients succeed in a rapidly evolving technology landscape.

Prior to joining Russell Reynolds Associates, Angela served in the US Army as a Military Intelligence Officer and was one of the first women assigned to an Infantry Battalion. She rose through the ranks from Lieutenant to Captain and held multiple leadership positions across information security, operational security, and anti-terrorism in support of a Brigade Combat Team’s operations in the Pacific Theater.
Angela received her BS in biology from the University of Miami and her MBA from Columbia Business School. She also speaks fluent Korean.

Sebastian Stening leads Roche’s global Device & Packaging organization, ensuring manufacturing readiness and orchestrating cross-functional collaboration across device development, procurement, quality, regulatory, supplier management, and site operations. He also serves as Global Head of Device, Packaging and Distribution Manufacturing Science & Technology, with responsibility for device industrialization strategy, end-to-end platform implementation, and medical device portfolio performance across Pharma TechOps.

Sebastian joined Roche from Bayer, where he established and led the Global Medical Device MSAT organization, spanning device development, industrialization, and technical lifecycle management for a broad portfolio across biotech, oncology, and cell and gene therapy. At Bayer, his responsibilities also included the development, industrialization, and launch preparation of the Eylea 8 mg drug-device combination product.

Prior to Bayer, Sebastian held multiple leadership roles at Sanofi across device development and industrialization, working on Dupixent across multiple functions to support submission and launch readiness. He holds B.Sc. and M.Sc. degrees in Business Administration and Engineering, with a focus on physics and medical devices, from the University of Applied Sciences Münster, and is a certified Six Sigma Black Belt.

Miranda Neville joined Autolus in 2018 from the consulting firm AllianceBio where she spent four years as a Partner and supported several clinical stage CDMO and commercial biopharmaceutical companies. Following her BS at West Virginia University, she started her career at Human Genome Sciences, Inc. She spent 10 years at HGS in a variety of roles including Manufacturing, Engineering & Program Management, prior to its acquisition by GlaxoSmithKline.

Satarupa Das leads commercial product CMC teams, providing end-to-end technical CMC leadership for regulatory submissions and approvals, yield and CoGm improvements, and strategies that support uninterrupted supply, business continuity, and risk mitigation. She also serves as the Operations representative for pipeline products, helping drive operations readiness for new product launches. In her current role, she leads a team focused on agile CMC approaches for accelerated approvals, as well as the implementation of alternative raw materials to improve cost of goods, sustainability, and supply resilience across the product lifecycle. Before joining AstraZeneca, Satarupa worked at Novavax in Manufacturing Quality Control and technology transfers and at Covance as a Lead Scientist in clinical studies. She holds a PhD in Biochemistry and completed her postdoctoral training at the National Cancer Institute, NIH.

Nidhi Shah is a pharmaceutical and biotechnology leader with over 30 years of experience in biopharmaceutical manufacturing, cell therapy, aseptic operations, quality control, and business leadership. As Senior Director of CAR-T Cell Therapy Manufacturing Operations at Bristol Myers Squibb, she leads manufacturing operations supporting innovative cell therapy treatments. Recognized for her results-driven leadership and operational excellence, Nidhi has extensive expertise in strategic operations, quality systems, regulatory compliance, and commercial manufacturing within highly regulated environments.

A recognized industry thought leader, Nidhi represented the United States as a delegate in the global revision of ISO Standard 14644-5, collaborating with international experts to shape best practices and standards for cleanroom operations. Throughout her career, she has successfully supported and participated in inspections and audits conducted by health authorities worldwide, reinforcing a strong culture of quality and compliance.

Nidhi has been an active contributor to several leading industry organizations. She has served on the Planning Committee for PDA’s CCS (Contamination Control Strategy) Workshop and has been a featured speaker at industry forums. She also co-authored the “Global Sterile Manufacturing Regulatory Guidance Comparison & Assessment Tool” for the Parenteral Drug Association (PDA), collaborating with four industry colleagues, and has presented on this work at PDA workshops.

In addition, Nidhi previously served as an Executive Board Member of the ISPE New Jersey Chapter and currently contributes to the ISPE Global Aseptic Conference Planning Committee. She also serves as a liaison and panelist for Women in Pharma, advocating for professional development, leadership advancement, and diversity within the biopharmaceutical industry.

Krista has been in the pharmaceutical industry for 30 years and brings expertise across both large pharmaceutical organizations and startup biotech environments. She is a results-driven leader specializing in GxP quality management throughout all phases of drug development. Krista is passionate about advancing modern, risk-based quality strategies that foster a strong culture of quality, maximize resources, and reduce non-value-added activities. Recognized for delivering exceptional results in rapidly changing environments, she has a proven track record of building cultures of quality, empowerment, and accountability across global, cross-functional, and matrixed organizations.

Kara has over two decades of global experience in the development and manufacturing of a broad range of biologic therapeutics. Trained in chemical and biological engineering, she began her career at Merck & Co., where she contributed to the development and manufacturing of live-virus vaccines. Kara subsequently joined Genentech, a member of the Roche Group, where she spent over 14 years working in areas of increasing responsibility across process development, manufacturing sciences, CMC team leadership, and global technology strategy.

Prior to joining Enlaza Therapeutics, she served as Senior Vice President, Head of CMC & Process Development and a member of the executive team at NGM Biopharmaceuticals. In that role, she led a multi-disciplinary team to deliver three successful first-in-human molecules in less than 12 months and built capabilities to support registrational trials for two lead programs.

Kara completed her Ph.D. and M.S. in Chemical Engineering at Stanford University, where she was a National Science Foundation Graduate Fellow conducting research in cell-free protein synthesis. She received her B.S.E. in Chemical Engineering with a certificate in Engineering Biology from Princeton University.

In his current role as SVP Technical Development at BioMarin, Ganesh Vedantham is responsible for strategic and technical oversight of Process & Product Development, Clinical Manufacturing, and CMC Lifecycle Management. Previously, Ganesh spent more than two decades at Amgen/Immunex in increasingly senior roles across the organization in various sites. He is known for demonstrating strategic vision, the ability to build and lead diverse and high-performing teams, and encouraging open, collaborative, supportive, and driven cultures. Ganesh earned a Ph.D. in chemical engineering from Carnegie Mellon University, a M.S. in chemical engineering from Rensselaer Polytechnic Institute, and a B.Tech in chemical engineering from the Indian Institute of Technology, Kharagpur.

Alec Nielsen is co-founder and CEO of Asimov, a Boston-based mammalian synthetic biology company. He holds a B.S. in Bioengineering and Electrical Engineering from the University of Washington, and a Ph.D. from MIT Biological Engineering, where he researched foundational biochemistries for synthetic biology, computer-aided genetic circuit design, and machine learning applications in biosecurity. Alec’s mission is to advance humanity’s ability to design living systems, enabling biotechnologies with outsized benefit to civilization.