Pam Witte Email & Phone Number

Seattle, Washington, United States

Seattle, Washington, United States

-Team lead for technical development activities for clinical NGS products in the New Indications team of the Molecular Product Development (MPD) group. Support development and validation activities for new Laboratory Developed Tests (LDTs) and single-site IVD product applications within a matrixed core-team environment. -Initiate and manage IVD-level verification and validation studies, providing innovative strategies to adhere to appropriate regulatory guidance, specifically CLSI, abiding by study timelines, product development plans, design trace matrices and other Design Control related requirements.

Seattle, Washington, United States

-Design transfer, development, optimization, and validation of NGS IVD assay and associated methods for regulatory submission for clinical use.-Process engineering including working with automation to enable high-throughput processing.-Process improvements, identification and testing of controls, stability testing.-Technology tranfer to production environment.-Draft technical regulatory documents for FDA level submissions.

Seattle, Washington, United States

-Analytical validation support for assays, related substances, and equipment.-Method development, stability analysis and QC support for products.-Experimental design development and execution, including technical writing of Method Validation Plans and Reports.-Document control, LIMS, CLIA/CLEP/CAP, extraction, PCR, NGS, SOP, technical writing.

Bellevue, Wa

-Clinical sample processing using a novel blood biopsy assay and next generation sequencing to determine the specific genetic mutations underlying various cancers and to determine the best treatment options based on individual patient results.-Biochemical Assays. NextGen sequencing technology (Illumina). Cancer diagnostics. Blood biopsy, Clinical assays. CLIA.

Bainbridge Island, Wa

-Custom gene to structure crystallography service provider.-Team lead for cell culture, protein production, and protein assay core teams.-Built and managed a seven day a week operation for large scale protein production (mammalian and insect cell) and analysis. -Coordinated cross functional efforts working with as many as ten project managers on multiple projects per manager to provide results and advice to complete projects for clients, which ranged from large pharmaceutical companies to small academic labs. -Acquired and implemented new processes on an ongoing basis to continually increase efficiency, decrease timelines and reduce costs with the goal to continue full-scale operations while investigating trial methods.-Maintained fast-paced, highly customized projects in multiple areas of research with a wide array of targets. -Molecular Biology, Cell Biology, Protein Expression, Protein Purification, Assay Development, Protein Stability Assays, Enzyme Kinetics, Small Molecular Inhibitor Studies, Drug Discovery, External Collaboration, CRO interactions.