Experience

A-Alpha Bio

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Process Engineer

  • May 2022 - Present

  Seattle, Washington, United States



Adaptive Biotechnologies Corp.

• United States
• Biotechnology
• 500 - 600 Employee

• Scientist I, Supervisor

  • Oct 2021 - Mar 2022

  • Led a team responsible for the execution of CLIA and IVD-level verification and validation studies on the clonoSEQ and T-Detect assay platforms including assigning tasks and responsibilities, providing training and development opportunities, and assessing performance of direct reports. • Managed study preparation and execution in close collaboration with New Indications study leads by drafting appendices and the study execution of protocols, creating work orders and training slides for… Show more • Led a team responsible for the execution of CLIA and IVD-level verification and validation studies on the clonoSEQ and T-Detect assay platforms including assigning tasks and responsibilities, providing training and development opportunities, and assessing performance of direct reports. • Managed study preparation and execution in close collaboration with New Indications study leads by drafting appendices and the study execution of protocols, creating work orders and training slides for operations, procuring samples, reserving critical reagents, contriving samples, overseeing execution in collaboration with sample management and laboratory personnel, documenting experimental details in spreadsheets, and assisting with report writing. • Provided cross-functional support for study execution. • Managed timely completion of documentation and online entries into document control system. • Provided onboarding training pertaining to laboratory operations and assay workflows for all new members of the New Indications team • Managed lab resources, reagents, shared lab samples, and other resources.. • Led process improvement projects from MPD pertaining to studies run through laboratory operations. • Responsible for developing and maintaining employee onboarding tools • Handled all personnel manners for team members, such as, staffing, training, coaching, and other related activities. • Regulatory responsibilities per Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).

• Senior Research Scientist

  • Jan 2021 - Oct 2021

  • Led study execution of IVD-level verification and validation studies. • Managed study preparation and execution by reading and understanding laboratory protocols, procuring samples, reserving critical reagents, contriving samples, overseeing execution, documenting experimental details in spreadsheets, and assisting with report writing. • Provided cross-functional support for study execution. o Used existing LIMS processes and outputs to ensure correct study execution. o Worked… Show more • Led study execution of IVD-level verification and validation studies. • Managed study preparation and execution by reading and understanding laboratory protocols, procuring samples, reserving critical reagents, contriving samples, overseeing execution, documenting experimental details in spreadsheets, and assisting with report writing. • Provided cross-functional support for study execution. o Used existing LIMS processes and outputs to ensure correct study execution. o Worked with Clinical Development to create study plans to incorporate available samples into protocols for CV and AV studies. o Worked with the Operations Lab and Biological Sample Management (BSM) to generate sales force orders, sample manifests, and schedule study execution. • Led the contriving of samples in the operations laboratory and execute development studies to optimize validation parameters prior to AV execution. • Managed timely completion of documentation and online entries into document control system. • Supported technology transfer to production environment. • Regulatory responsibilities per Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).

• Validation Scientist II

  • Mar 2020 - Jan 2021

  Seattle, Washington, United States • Contributed to the overall product development planning and implementation for IVD assays and other methods used in the Adaptive clinical laboratory • Developed verification and validation protocols under Design Control • Executed and/or supervised development work, verification and validation studies • Analyzed study data and write study reports • Participated in cross-functional teams (including comp. bio., software, clinical operations, manufacturing, quality and… Show more • Contributed to the overall product development planning and implementation for IVD assays and other methods used in the Adaptive clinical laboratory • Developed verification and validation protocols under Design Control • Executed and/or supervised development work, verification and validation studies • Analyzed study data and write study reports • Participated in cross-functional teams (including comp. bio., software, clinical operations, manufacturing, quality and regulatory) • Drafted technical regulatory documents for FDA level submissions

• Validation Scientist I

  • Oct 2017 - Mar 2020

  Greater Seattle Area • Systematically identified high-impact production laboratory bottlenecks/inefficiencies or other critical improvements needed in existing processes • Worked with production lab personnel, automation engineers and LIMS developers to design optimization solutions. • Performed and document risk-assessments and change control requirements • Executed and document validation of new optimization solutions for deployment to production • Assisted or lead training of key personnel in new… Show more • Systematically identified high-impact production laboratory bottlenecks/inefficiencies or other critical improvements needed in existing processes • Worked with production lab personnel, automation engineers and LIMS developers to design optimization solutions. • Performed and document risk-assessments and change control requirements • Executed and document validation of new optimization solutions for deployment to production • Assisted or lead training of key personnel in new processes • Documented associated updates and changes to SOPs, PROs, METs, and other controlled documents. • Routinely supported additional validation group activities, as needed. • Timely completion of documentation and online entries into document control. • Adhered to CLIA/CAP/GLP systems and processes in the lab; maintain a high quality and accuracy of work.

• Production Associate II, Team Lead

  • Mar 2014 - Oct 2017

  Greater Seattle Area General duties: Assisted Clinical Laboratory Scientists in daily operations of the lab, maintained inventory and restocked the lab, trained new employees, attended meetings to help develop LIMS and other process improvements. Lab processes performed: • Accessioned of all incoming clinical and research samples • Cell isolation using Ficoll or RBC Lysis methods • FFPE extraction from blocks and slides • Bone marrow smear slide extractions • Cellular DNA extraction using Qiagen… Show more General duties: Assisted Clinical Laboratory Scientists in daily operations of the lab, maintained inventory and restocked the lab, trained new employees, attended meetings to help develop LIMS and other process improvements. Lab processes performed: • Accessioned of all incoming clinical and research samples • Cell isolation using Ficoll or RBC Lysis methods • FFPE extraction from blocks and slides • Bone marrow smear slide extractions • Cellular DNA extraction using Qiagen kit method • DNA extraction using Kingfisher method • Cellular isolation using beads method • Monitored temperature logs • Prepared reagents • Performed equipment maintenance • Created sample batches



Strada Communication, Inc.

• TypeWell Transcriber

  • Oct 2013 - Mar 2014

  Remote Provided realtime communication access for deaf and hard of hearing students using TypeWell software.



Genomic Health

• United States
• Biotechnology Research
• 100 - 200 Employee

• Histology Assistant

  • Jan 2012 - Dec 2012

  Redwood City, CA Assisted histotechnologists and pathologists in daily operations of histology lab by managing and organizing inventory, assisting in research studies, batching samples, verifying specimen labeling, specimen preparation including sectioning, staining and macrodissection of FPET tumor samples, gathering pathology reports from physicians, documenting case status in a lab information system, training new employees and aiding in general upkeep and inventory in a clinical and research lab.



Western Washington University

• United States
• Higher Education
• 700 & Above Employee

• Transcriptionist

  • Jun 2005 - Aug 2011

  Bellingham, WA Cooperatively worked in a team setting to provide real-time communication access to deaf and hard of hearing students, generate edited transcripts from class transcriptions and completed 3 month prescribed course of study to become a qualified TypeWell employee.