Kate Watts Email & Phone Number

Seattle, Washington, Us

• Lead a team of 10 scientists and engineers to develop upstream cell culture, downstream purification, formulation, and aseptic fill processes for viral vector manufacturing in support of pre-clinical and clinical stage allogeneic CAR-T cell therapy programs. • Lead cross-functional CMC sub-team for viral vector to drive the strategy and execution of CMC deliverables under rapid timelines. • Author relevant CMC sections for IND and IMPD regulatory filings.• Oversee non-GMP pilot plant operations, technology transfer into manufacturing, and GMP production activities for Master and Working Cell Banks, plasmids, and viral vector drug substance intermediate.

Seattle, Washington, Us

Led viral vector upstream process development, pilot plant operations, and technology transfer to GMP manufacturing in support of the advancement of allogeneic CAR-T programs into regulatory filings and clinical trials.

Seattle, Washington, Us

• As part of Technical Operations / CMC development for cell and gene therapies, performed diligence on cell lines, including pluripotent stem cell and immortalized human cell lines, and developed strategies for cell banking and clinical manufacturing readiness.• Partnered with architects and site operations to design, build and start-up a new pilot plant.

North Chicago, Illinois, Us

Cell Line Development and Cell Culture Process DevelopmentProcess Sciences, Oncology• Led upstream process and manufacturing activities for a late-stage ADC program, including CMO partnership evaluation, tech transfer to internal and external commercial manufacturing sites, risk assessments in support of process characterization and validation, on-floor support of PPQ batches, and BLA/MAA preparation.• Led a cell line development and upstream process development team to establish workflows, timelines, and platform processes using multiple CHO expression systems for production of monoclonal antibodies, bispecific antibodies, and other recombinant proteins. • Partnered with multiple AbbVie sites to develop expression technology strategies for research and commercial use, led alignment initiatives for cross-site Development Sciences and Operations teams, and worked cross-functionally to develop CMC transfer workflows for programs progressing from early to late stage development.

South San Francisco, California, Us

Cell Line Development and Cell Culture Process DevelopmentProcess Sciences, Development Sciences• Led stable CHO production cell line development and upstream process development of antibodies for ADC therapeutic candidates from DNA to Master Cell Bank and GMP production under rapid CMC timelines.• Led upstream manufacturing design and start-up of an internal single-use GMP manufacturing facility for production of multiple ADCs in support of Phase I/II US and EU clinical trials.• Authored cell line and cell culture CMC sections for multiple IND filings that enabled first-in-human clinical studies of ADCs for treatment of solid tumors.• Represented CMC on the Lung Cancer Product Development Team to drive timelines and strategies for moving programs from preclinical to clinical development, and oversaw transitions of programs from Research/Discovery target validation into development.• Implemented automation technologies including FACS single-cell cloning with plate imaging to support clonality and the ambr250 automated micro-bioreactor system to support clone selection, process optimization, and cell line stability studies.

Rahway, New Jersey, Us

Upstream Process DevelopmentBioprocess Development, Biologics New and Enabling Technologies• Developed upstream cell culture and fermentation processes for recombinant proteins expressed in CHO, Pichia pastoris, and E. coli through design and execution of experiments in support of clone selection, genetic stability assessment, and process optimization in 2L to 2,000L bioreactors• Coordinated technology transfer activities and provided on-floor support in pilot and GMP manufacturing plants for production of preclinical and clinical batches• Led technology development projects for single-use bioreactors, process intensification through high-cell density perfusion, and harvest/primary recovery systems• Co-designed and performed prototype testing of the ambr250 automated micro-bioreactor system in partnership with TAP Biosystems (acquired by Sartorius Stedim)

Dallas, Texas, Us

Staff leader at summer camps serving children with chronic illnesses and major physical disabilities.

Durham, North Carolina, Us

Engineer working to repair medical equipment in local hospitals and clinics in El Salvador.