Concord, Massachusetts, United States
Summary of leadership and technical CMC experience Experienced professional and leader with 20+ years of experience in biopharmaceutical development and manufacturing sciences, including the past 6+ years in cell and gene therapy. Have led both Process Development and MSAT functions at different companies, sites, and in support of diverse therapeutic modalities. Leadership roles that span the CMC life-cycle: Phase 1 to Phase 3 product and process development, technology transfer, regulatory approval, launch, commercial manufacturing, and post-approval life-cycle management. Diverse leadership roles at a large, multinational biopharmaceutical company (Amgen) and a pioneering cell and gene therapy company (bluebird bio). o Functional area leadership and organizational design o Served on leadership teams at site level and large organizations with 100+ staff o Responsible for setting organizational goals, accountability, and alignment with broader organization/company strategy o Budget and resource accountability o Partnering with and influencing Quality, Manufacturing, Attribute Sciences, Regulatory, other CMC functions, and external partners to drive CMC life-cycle product development and business objectives/strategy o Led and managed teams and staff that span a broad set of technical/scientific responsibilities and process scales within CMC: mammalian cell culture, purification, viral vector production, data analytics, material science, fill/finish, and autologous hematopoietic stem cell (HSC) production o Led MSAT team that supported several $1B+ annual revenue products o Leadership role in planning and executing complex technology transfers involving ~$200M capital expenditure and $1B+ products Served on Joint Steering Committees with external CMOs and external development partners (e.g., Celgene/BMS for Abecma®) to drive strategy, execution, and alignment of priorities. CMC life cycle experience across a diverse set of modalities: protein-based therapies, mAbs, biosimilars, viral vectors (LVV), CAR-T, and genetically modified HSCs for autologous cell and gene therapy. Drives and fosters an attribute-focused, QbD approach to process and product development. Track record of successful FDA licensure for commercial products: most recently, autologous CAR-T (Abecma®) and three autologous HSC therapies (Skysona™, Zynteglo™, Lyfgenia™)
Providing executive level and strategic consulting in CMC, Commercialization, and Technical Operations for biologics and cell and gene therapies March 2025 - January 2026: Strategic CMC consulting for StealthCo immuno-oncology company
Vice President: Process, Data, and Manufacturing Sciences (July 2021 to Present) Senior Director, MSAT (December 2019 to July 2021) Overview of roles: From December 2019 to July 2021, I led MSAT (i.e., Process Engineering team) at bluebird bio after transitioning from the lead of Viral Vector Process Development. The MSAT team had ~30-40 scientists and engineers who provided commercial support, process engineering, and CMC life-cycle support for lentiviral vector used for Abecma®, a CAR-T, and three autologous HSC gene therapy products at evolving stages of CMC life-cycle. During that time, bluebird bio and Celgene/BMS submitted a BLA and obtained approval in March 2021 for Abecma®, the first approved CAR-T for the treatment of Multiple Myeloma. In November 2021, bluebird bio had a spin-off of its oncology franchise (2seventy bio). From there and due to specific product and CMC life-cycle needs, the MSAT team and I remained at bluebird bio. Over the next several years, I rebuilt critical organizational capabilities, reorganized the team to serve CMC and business needs, and ultimately formed the current team: Process, Data, and Manufacturing Sciences. The scope of the team spans Process Development responsibilities across lentiviral vector (LVV) and autologous cellular therapy, Data Systems and Analytics, MSAT across both LVV and autologous cellular therapy manufacturing at CMOs, and technical raw material support (i.e., Material Science). To date, we and our cross-functional partners are serving patients with these pioneering approaches to curative cell and gene therapy. Further, we continue to work towards improving manufacturing success rate and patient experience for autologous cell and gene therapies via post-approval CMC life-cycle management
Overview of past role: I led a team of ~25-30 cell culture and purification scientist and engineers who formed an organization called Vector Process Development. The team was responsible for developing and characterizing lentiviral vector (LVV) processes for CAR-T, TCR and gene therapy applications, next generation suspension LVV process, technology transfer of clinical stage assets, and authoring pertinent sections of regulatory filings. In addition, I served on the bluebird bio/Celgene Joint Manufacturing Committee and Joint CMC Team in support of the BCMA CAR-T program (eventually Abecma® product). Reorganized team to integrate upstream and downstream process skills for talent management and build organizational resiliency Became a key member of the bluebird bio/Celgene/BMS Joint Steering Committee and CMC teams to drive strategy and CMC life-cycle Engaged with CMC partners on comparability package and approach to support to transition from adherent LVV process to suspension LVV process across multiple autologous cell therapy products Served on Process and Analytical Development leadership team Authored bluebird bio scientific/technical job leveling guidelines in support of talent management and staff development Team accomplishments from August 2018 to December 2019 Approval of Zynteglo in EU Technology transfer of suspension LVV process to CMO and to bluebird bio’s facility in North Carolina Successful implementation of suspension LVV (sLVV) platform for BCMA and LentiG FDA approval of suspension comparability and filing package for introduction of sLVV into bb21217 clinical study (next gen BCMA product) Comparability and filing package submitted to FDA for sLVV LentiG Successful engineering runs of LentiG sLVV in preparation for PPQ Successful technology transfer of BCMA sLVV process to bluebird’s Research Triangle site in North Carolina Completion of sLVV process characterization studies for BCMA and LentiG products
Director of Process Development, Amgen Inc. March 2017 to August 2018 Kendall Square, Cambridge, MA Amgen Process Development Pivotal Drug Substance Bioprocess Sciences and Technologies (Interim role: Material Science) (June 2017 to January 2018) Overview of past role: I led a team of 25 cell culture and purification scientist and engineers who formed an organization called Pivotal Drug Substance Bioprocess Sciences and Technologies. This organization was within Amgen’s Process Development organization. The team was responsible for phase 2 and 3 (i.e., pivotal) process development for drug substance, encompassing QbD-based process design that focused on product attributes, process characterization, developing process and attribute-related control strategies, and authoring relevant CMC sections of regulatory filings (IND and BLA). The team advanced Amgen’s pipeline, including biosimilars and immuno-oncology assets, through partnerships with internal functions as well as external partnerships with CDMOs (contract development and manufacturing organization). Overview of interim role (Material Science): In addition to my primary role, I took on an interim role in leading the Material Science function from June 2017 to January 2018. The team included 5 scientist and several dotted line reports located at several domestic and international Amgen sites (Puerto Rico and Singapore). In this role, I participated in the redesign of the organization as well as leading the team to deliver its standard business and technical outputs. The technical responsibilities of the group spanned several raw material categories: media, chemicals, excipients, chromatography resins, filters, and single-use systems.
Director of Process Development, Amgen Inc. March 2016 to March 2017 Kendall Square, Cambridge, MA Amgen Process Development Pivotal Drug Substance Purification Process Development Overview of past role: Prior to the formation of the new Pivotal Bioprocess Sciences and Technologies organization, I led the Pivotal Purification Process Development organization, specializing in bioseparation technologies as part of the responsibility of advancing Amgen’s late-stage pipeline. This organization had responsibility for process development of Phase 2 and 3 assets, encompassing process design to authoring CMC sections of filings. Managed budget and resource allocation for a team of ~45 staff distributed in Massachusetts and Thousand Oaks Team’s technical responsibilities spanned harvest to final filtration of bulk drug substance Manage direct reports who had 10-15+ years of industry experience Collaborated with lead of Cell Sciences and Technologies to allocate resources, select cross-functional leads and plan execution of Amgen’s late-stage biosimilar, innovator and life-cycle management of biologics products Team accomplishments Submission of BLA for Aimovig® Submission of BLA for Enbrel® life-cycle management program Development of ultra-filtration/final formulation process to support high concentrate/high dosage of life-cycle management program Supported 10+ pipeline and biosimilar programs at various stages of process design, process characterization, PPQ and BLA authoring Site move from temporary site in Alewife, MA to renovated Amgen facility at Kendall Square while maintaining business continuity and safety performance
Director of Process Engineering, Amgen Inc. Juncos, Puerto Rico Amgen Manufacturing Limited I led the Process Engineering function within the Drug Substance Process Development organization at Amgen’s largest manufacturing facility. The Process Engineering function at Amgen is analogous to Manufacturing Sciences and Technology (MSAT) organizations at peer companies. The function had subject matter expertise in commercial scale GMP manufacturing processes, spanning large-scale mammalian cell culture (15kL scale), fermentation, harvest, and purification. The function had responsibility for commercial support, regulatory inspection support, process validation, process monitoring, life-cycle management and technology transfer while ensuring quality and compliance. Managed budget and resource allocation for a team of ~25 staff Manage direct reports who had 10-15+ years of industry experience Led team that supported two manufacturing facilities: a mammalian cell culture facility and a microbial facility Led team that supported multiple products that generated more than $1B revenue for Amgen Led and supported team through increase in production and initiation of 3 technology transfers to the site Designed teams and allocated resources to execute complex technology transfer projects (~$200M capital projects) Managed staff who led regulatory inspection support and prior approval inspections (PAI) Interfaced daily with Quality leadership, plant managers, and site leadership Team accomplishments Successful technology transfer, PPQ, PAI and approval of Nplate® Successful PPQ and regulatory approval of Prolia®/Xgeva® life-cycle management program With team’s support the microbial facility won Amgen’s Best Plant award in 2016 With team’s support the mammalian cell culture facility won Amgen’s Most Improved Plant award in 2015