Kathy Leach Email & Phone Number

Experienced professional providing technical and strategic consulting for the biologics and cell/gene therapy industries. Focus on CMC activities including process & analytical development, health authority interactions. Have supported early- and late-stage clinical products.

New York, Ny, Us

Responsible for the process and product development for a clinical-stage lentiviral vector-transduced hematopoietic stem cell product for hematologic disease. Develop and implement CMC strategies for process control, specifications, stability, raw materials, residuals for both the lentiviral vector as well as the cell product. Oversee commercial process and analytical method development at contract manufacturing organizations and contract test laboratories.

Seattle, Wa, Us

Responsible for the Quality strategy and management for key CMC programs across all Juno’s cell-therapy products. These include the test method lifecycle, product specification, stability, and product quality trending programs. Accountable for the oversight of Quality Control operations at contract manufacturing and testing organizations on behalf of Juno. Lead a team of Quality professionals and analytical scientists.

Seattle, Wa, Us

Responsible for communication, infrastructure projects, and meeting management for Juno Therapeutics Technical Operations Department.

Seattle, Wa, Us

Responsible for the internal and external communications and infrastructure for the Process & Analytical Development group. Provide project management support for departmental programs.

Seattle, Wa, Us

Leading the Analytical Development department with broad responsibilities in helping Juno characterize its products and control their manufacturing processes.

Thousand Oaks, Ca, Us

Business Process Owner – Establish goals for continuous improvement of early- and late-stage process development business process (requirements, deliverables) and ensure timely progress toward goals is made and communicated to clients, stakeholders, and management. Provide necessary training and enable feedback mechanisms to ensure that process improvements are well integrated. Led team to design and implement new business process for formulation development and commercialization.Project Manager – Provide team support through management of team interactive site (SharePoint), team timeline (using Microsoft Project) and team communications (meeting agendas and minutes, announcements, etc). Proactively track, manage, and communicate team goals through use of dashboards or milestone charts.Cross-Functional Team Lead – Lead or co-lead teams within Process and Product Development (P&PD) or between P&PD and other internal client/partner groups for departmental initiatives (process improvements) or company initiatives (Quality by Design). Develop team charter, project goals and timeline. Communicate project status to peers and management through formal presentations, informal updates (e-mails, Sharepoint announcements), and team meeting minutes and documentation.

Thousand Oaks, Ca, Us

Product Quality Team Leader – Responsible for ensuring that Amgen’s products are suitable for their intended uses and embody uncompromised product quality. ○ Manage the quality risks to patients and ensure the safety, identity, strength, purity and quality of the product. Own and justify product specifications. Ensure analytical methods are fit-for-purpose. Coordinate the development of sample plans to ensure on-process testing is sufficient to support future development of in-process controls or specifications. Own and/or support nonconformance investigations in QC and manufacturing to ensure patient safety. Author analytical comparability protocols and reports to ensure that process changes are successfully supported though regulatory filings. Develop and manage timeline for Quality Team deliverables to ensure on-time completion of critical tasks.○ Proactively assess technical issues and ensure that consistent standards are applied across all products at all stages of the development lifecycle. Write CTA sections, respond to questions from heath authorities. Ensure platforms are current with changing regulatory climate and appropriate for new international jurisdictions.○ Coordinate operational strategies with process development, drug product & device development, formulation development, supply chain, manufacturing, regulatory, finance, and environmental health and safety.Projects – Led cross-functional team focused on implementation of consistent analytical and inspection methods for the detection and reporting of visible and subvisible particles within clinical operations and quality. Liaised with Process Development and Drug Product groups on particle related topics. Represented Quality on QbD team on Process Change Management. Served as Clinical Quality business process owner for commercial process development.

Thousand Oaks, Ca, Us

Analytical Chemistry – Developed chromatographic methods for the quality control and characterization of antibodies. Transferred methods to Quality Control (QC) for GMP testing of clinical products. Authored CTA sections to support clinical studies. Managed GLP testing lab for 8 months. Served as AWA Analytical Sciences (AS) representative on Method Commercialization and Analytical Method Qualification Guideline teams. Served as trainer for AS and QC staff on Method Qualification Guideline.Project Team – Led interdisciplinary and cross-site teams (AMG 479 Process Team, Enbrel Drug Product Team, and AMG 162 CP3 Process Team) responsible for the progression of an antibody products from research candidate through clinical product. Led Media Development Technology Development Team a cross-site research team focused on developing and implementing new cell culture media recipes, including fully-defined media.

Us

Formulation work – Conducted pre-formulation studies to determine key instabilities of protein molecules and to optimize formulation (pH, ionic strength, excipients, etc) for maximal stability; Developed models for prediction of long-term refrigerated storage stability from short term (accelerated) stability studies; Set up real-time stability studies in advance of GMP stability studies for early evaluation of product shelf-life; Member of project teams, representing ACF and supporting any needs for formulation changes or stability studies; Member of technology transfer teams, representing ACF for the transfer of formulation information to manufacturing and fill/finish facilities.Drug Delivery work – Determined the feasibility of various drug delivery technologies and made recommendations for application with approved Immunex products or molecules in development; Coordinated and supported feasibility studies combining appropriate drug delivery technologies with Immunex molecules (e.g. PEGylation, intradermal infusion, injection systems); Member of project teams representing formulation group and providing presentations on drug delivery options for product enhancements.

Seattle, Wa, Us

Worked with Buddy Ratner and Allan Hoffman (Bioengineering Department)Surface functionalization of polymeric materials. Part of University of Washington Engineered Biomaterials (UWEB) program which was set up to study the benefits of biomaterials with engineered surfaces to direct the process of healing. Learned polymer surface modification and characterization techniques, cell culture systems, and cell function assays.

Phd, Biology And Medicine

Sb, Chemical Engineering