Jared Bee

About Jared Bee

Senior biopharmaceutical leader with a PhD in Chemical and Biological Engineering and over 15 years of experience in technical operations and biologics product development. Proven track record of building and leading high-performing teams to advance programs from preclinical development through BLA submission. Broad expertise across biologics and advanced modalities, including high concentration monoclonal antibodies, antibody-drug conjugates, engineered and multispecific proteins, AAV gene therapies, enzymes, and vaccines. Highly collaborative and strategic leader recognized for authoring regulatory submissions and influencing internal and external stakeholders to drive successful outcomes.Key Skills • Strong understanding of CMC functions and activities including cell line development, cell culture, purification, formulation, fill-finish, technical transfer, and analytical development. • Managed complex product development projects involving several functions and activities requiring effective communication with multiple internal and external stakeholders.• Collaborated extensively with research, pre-clinical development, supply chain, project management, product manufacturing, quality control, quality assurance, regulatory affairs, clinical supply and development, medical affairs, commercial, legal, and finance.• Direct experience leading analytical sciences and formulation & drug product development groups in multiple organizations.• Managed department budgets and prioritized the use of resources to meet project timelines and objectives. • In-depth understanding of FDA, ICH, and EMA guidelines and their impact on process and product development.• Highly experienced at writing clear and compelling documents for regulatory agency interactions, numerous INDs, and multiple BLA submissions including for Imfinzi®, Fasenra®, Lumoxiti®, Saphnelo®, Margenza®, and RGX-121 (ongoing). • Performed process risk assessments, developed strategies, and led the execution of late-stage characterization and validation activities aligned with an overall control strategy.• Proficient in process-related residuals and extractables and leachables risk assessments and workflows. • Authored and/or reviewed CQA assessments, justification of specifications, analytical method development, and analytical validation reports. • Championed innovation and use of technology realized in the form of 10 patents, 36 scientific publications, and multiple presentations. • Track record of building high-performing teams, mentoring staff, and developing talent.

Experience

1. Head of Formulation and Drug Product Development

   REGENXBIO

   Mar 2019 — Present

   Led a team developing adeno-associated virus (AAV) gene therapy drug products suitable for various administration routes.• Identified and implemented strategies to minimize material required for development activities.• Designed and transferred robust drug product process steps to external CMOs for both clinical and late-stage programs.

Education

• University of Colorado Boulder

  PhD, Chemical and Biological Engineering

• University of Oxford

  M.Chem., Chemistry