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    Amanda Pace

    Director, Cell Therapy Process Development at Bristol Myers Squibb

    Professional Background

    Amanda Pace is a distinguished engineering leader in the biopharmaceutical industry, bringing forth a wealth of experience and expertise in cell therapy and biologics. With a commendable career shaped by pivotal roles in major pharmaceutical companies, she has emerged as a critical figure in the development and commercialization of monoclonal antibodies. Amanda excels in formulation technical development project activities and has mastered the intricacies of cell therapy process development and transfer. Her innovative approach has been instrumental in formulating liquid drug products for both intravenous (IV) and subcutaneous administration, specifically targeting the needs of Phase III clinical trials and the final stages of commercial development.

    Throughout her illustrious career, Amanda has demonstrated her capability in investigating product issues, addressing customer complaints, and providing insightful solutions. She has worked diligently to ensure a seamless transfer of drug product processes for both antibody and cell therapy to internal Good Manufacturing Practice (GMP) facilities and external contract manufacturing organizations.

    Her tenure at prestigious organizations such as Bristol Myers Squibb and Juno Therapeutics has further solidified her reputation as a skilled engineer and manager. Her broad skill set includes a deep understanding of design of experiments (DOE) and Quality by Design (QbD) principles, which she employs to design and characterize liquid parenteral formulations adeptly. Proficient in the use of the JMP statistical software, Amanda effectively facilitates the analysis and implementation of complex data, driving her projects toward success.

    Amanda is not only a proficient engineer but also an accomplished researcher. She has developed an in vitro UV hemolysis assay to assess the impact of high concentration formulations administered subcutaneously, highlighting her commitment to safety and efficacy in drug delivery.

    Education and Achievements

    Amanda Pace pursued higher education at The Johns Hopkins University, where she obtained both her Master of Science in Engineering (MSE) and Bachelor of Science (BS) in Chemical and Biomolecular Engineering. Her educational foundation laid the groundwork for her impressive career, where she has continued to expand her knowledge and skills continually.

    During her time at Johns Hopkins University, she engaged in various research projects, developing a strong understanding of chemical and biomolecular engineering principles. This educational background has served her well as she has advanced through various roles in the biopharmaceutical industry.

    Career Progression

    Amanda's career began at Genentech, where she started as a Research Assistant and progressively ascended through roles including Research Associate, Senior Research Associate, and Engineer II. Her practical experience at Genentech equipped her with the foundational skills needed to tackle complex engineering challenges in the biopharmaceutical sector.

    After honing her skills at Genentech, Amanda transitioned to Juno Therapeutics, Inc. as a Senior Process Engineer, where she further perfected her process engineering skills in cell therapy. Her exceptional performance and leadership qualities led her to Bristol Myers Squibb, first as an Associate Director and later as a Director. In these capacities, she has provided strategic direction and oversight on critical projects related to drug development and commercialization.

    Notable Achievements

    • Process Characterization and Validation: Amanda has authored CMC sections for various regulatory submissions, including Biologics License Applications (BLA), supplemental BLAs, Marketing Authorization Applications (MAA), Investigational New Drug Applications (IND), and more. Her comprehensive understanding of the regulatory landscape has made her invaluable in guiding drug formulations through the complexities of clinical trials.

    • Expertise in Various Techniques: Her technical proficiencies encompass key areas such as Chromatography (including IEC, SEC, and CE-SDS) and Biophysical characterization (including Differential Scanning Calorimetry (DSC), Circular Dichroism (CD), Rheology, and Atomic Force Microscopy (AFM)). This extensive skill set allows her to address the chemical stability of antibodies effectively, mitigating issues like deamidation and isomerization in biopharmaceutical products.

    • Thought Leadership: Amanda has showcased her expertise at numerous industry conferences, including her presentation at the American Chemical Society (ACS) Conference in Dallas in 2014. There, she discussed biochemical technology related to the correlation of Fc Methionine Oxidation Detection Methods, contributing to the body of knowledge in biopharmaceutical engineering.

    In addition to her technical and managerial accomplishments, Amanda is recognized for her ability to lead diverse teams and manage direct reports effectively. Her strong communication skills foster collaboration and ensure that project teams remain aligned in their objectives and efforts.

    Community Engagement and Professional Affiliations

    Beyond her professional endeavors, Amanda's commitment to the engineering community is noteworthy. As a dedicated professional, she is not only focused on personal success but also on the growth and advancement of her field. She embraces the importance of mentorship and actively seeks opportunities to guide and support the next generation of engineers and scientists.

    Amanda Pace continues to be a powerhouse in the realms of engineering and biopharmaceutical development. Her relentless pursuit of excellence, deep well of knowledge, and inspiring leadership affirm her status as a key player in her industry. As drug development evolves, Amanda remains at the forefront, ready to tackle new challenges and lead innovative solutions that enhance patient care worldwide.

    Related Questions

    How did Amanda Pace develop her expertise in cell therapy and biologics?
    What are some specific challenges Amanda Pace has faced in drug development projects?
    In what ways has Amanda Pace contributed to regulatory submissions in the biopharmaceutical industry?
    How has Amanda Pace's educational background at Johns Hopkins University influenced her career trajectory?
    What innovative techniques has Amanda Pace employed in her role at Bristol Myers Squibb?
    Amanda Pace
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    Location

    Seattle, Washington