Kathleen Thorson Email & Phone Number

Durham, North Carolina, Us

Durham, North Carolina, Us

Provided quality assurance support to manufacturing processes, disposition operations, and analytical sciences as part of the contract manufacturing organization for clinical and commercial drug products. - Supported numerous NPI and PRI (New Product Introduction and Product Re-Introduction) campaigns through the review and approval of master batch records and related documentation. - Provided support of multiple client programs through the review and approval of technical reports, both new and revised SOPs, test methods, forms and stability protocols. - Reviewed and approved change controls, deviations and CAPAs related to the manufacturing process and analytical sciences.

Durham, North Carolina, Us

Performed review and verification of cGMP analytical method data, qualification/validation reports, technical documents, and batch summaries for manufactured clinical and commercial drug products.

Thousand Oaks, Ca, Us

Performed analytical method transfers, validations, troubleshooting, quality control testing, and ensured data integrity in a commercial manufacturing environment.• Participated in analytical method validations that included review of validation protocols and re-ports, assay performance, and data verification.• Successfully managed and participated in method transfers, training, and troubleshooting activities with teams at multiple sites in the United States, Puerto Rico and Germany.• Demonstrated proficiency in the performance of complex bioassays (proliferation, reporter gene, and phosphorylation), including utilization of Tecan automation, for stability study testing support.• Trained analysts in cell line maintenance and propagation (adherent and suspension cell lines).

Thousand Oaks, Ca, Us

• Qualified and validated host cell protein and impurity ELISAs for supporting process and product characterization activities. Authored and co-authored protocols and reports, determined ac-ceptance criteria, performed assays, and summarized results to pre-determined criteria.• Responsible for the transfer of ELISA and SDS-PAGE analytical methods among four sites. Man-aged the timelines and deliverables, transfer criteria, data generation, and documentation including: protocols, reports and summaries. Povided regular project updates to cross-site project teams.• Authored several peer-reviewed abstracts and posters at annual site-wide symposia for the pur-pose of information sharing and best practice discussions.

Thousand Oaks, Ca, Us

Provided analytical support to the Process Development and Analytical Sciences departments.• Demonstrated expertise in performing and troubleshooting ELISAs and Western blots. Supported investigations and problem solving activities for process development by providing data and analytical knowledge to members of diverse teams.• Performed numerous SDS-PAGE silver and Coomassie stained gels, Western blots, and LAL analytical methods to determine purity and identity of lot release, stability, process development and validation samples.

Responsible for discovery and development of various polymer drug delivery systems; document control. - Co-Author of Patent # 6261583, Issued July 17, 2001, Title: Moldable Solid Delivery System

Fort Collins, Co, Us

Research and development with M. leprae and M. tuberculosis bacteria in Biosafety Level 2 and 3.

Arlington, Virginia, Us