Cindy Cheung Email & Phone Number

Union City, Ca, Us

Menlo Park, California, United States

- Monitored and recovered CLIA laboratory NGS metric failures from two clinical sites (5000+ tests/week); implemented innovative mitigation efforts to prevent further decay and determined root cause through investigative datamining and studies in routine or tiger team urgent setting- Design new quality control methods for reagents and alternative materials with functionally correlated specifications to ensure reagent performance in automated multi-cancer detection assay- Optimize… Show more - Monitored and recovered CLIA laboratory NGS metric failures from two clinical sites (5000+ tests/week); implemented innovative mitigation efforts to prevent further decay and determined root cause through investigative datamining and studies in routine or tiger team urgent setting- Design new quality control methods for reagents and alternative materials with functionally correlated specifications to ensure reagent performance in automated multi-cancer detection assay- Optimize workflow processes and settings/parameters in current NGS workflow in development to optimize assay performance- Participate in product development and product design transfer of new specimen collection kit from concept to production as technical subject matter expert to ensure development of a structurally effective product to transport patient specimens- Facilitated the external technology transfer of assay-critical material to Suppliers to ensure product quality meets expectations through pilot evaluations, validation, and first article inspection- Participate in various Change Controls, CAPAs, and process changes as subject matter expert or main investigator to conduct investigation and to provide impact assessment and conduct improvements- Sole creator and manager of detailed assay workflow documents to aid in assay detail capture and PMA submission; worked inter-departmentally with Regulatory, Quality, Engineering to ensure regulatory compliance and information accuracy - Drafted assay failure mode analysis (FMEA) documents to aid in assay risk assessment for existing and upcoming assays; worked extensively with Regulatory and Quality to ensure regulatory compliance and supported ISO 13485 certification and surveillance audits as front room subject matter expert- Managed 2 scientists to conduct studies, including developing skills in study design, data analysis, and career development Show less

Redwood City, California, United States

- Designed and executed feasibility, development, validation studies to troubleshoot, improve, and support existing fully automated G360 sequencing oncology assay (IVD/RUO/LDT) by introducing new/optimized testing processes and materials. Lead study design, execution, data analysis, SOP drafts/approvals, and interdepartmental communications with Quality, Regulatory, Clinical Operations, Engineering, etc.- Proposed, developed, and led restructuring efforts of new, original instrument… Show more - Designed and executed feasibility, development, validation studies to troubleshoot, improve, and support existing fully automated G360 sequencing oncology assay (IVD/RUO/LDT) by introducing new/optimized testing processes and materials. Lead study design, execution, data analysis, SOP drafts/approvals, and interdepartmental communications with Quality, Regulatory, Clinical Operations, Engineering, etc.- Proposed, developed, and led restructuring efforts of new, original instrument performance qualification (PQ) processes to support IVD submission. Close interaction with Quality and Regulatory to meet all FDA requirements and feedback- Performed experimental or data investigation of CLIA laboratory NGS run failures and provide resolution by root cause analysis- Proposed and developed innovative quantitative volume verification method and performance assessment validation processes and methods for use in CAP-CLIA laboratory to ensure process quality control while maintaining ease of use for CLIA- Developed original workflow recovery processes to salvage precious clinical plasma from failed isolation workflow runs. Created standardized protocols and trained Clinical Laboratory Scientists with close interactions with Regulatory bodies to ensure compliance with CLIA laboratory standards and pharma requirements- Designed testing plan and validate the use of new raw and testing materials for use in the fully automated sequencing oncology assays (IVD/RUO/LDT) to determine the effects of new materials in relation to the performance of the sequencing results Show less

Pleasanton, California, United States

• Perform various feasibility and optimization experiments to improve the current library preparation protocol, thereby developing an improved IVD, fully automated sequencing NGS oncology assay on the Illumina platform• Conduct large scale, cross-platform study to compare the performance of various commercially available automated sample extraction platforms and their ability to generate quality nucleic acids for library preparation• Carry out validation studies to optimize new… Show more • Perform various feasibility and optimization experiments to improve the current library preparation protocol, thereby developing an improved IVD, fully automated sequencing NGS oncology assay on the Illumina platform• Conduct large scale, cross-platform study to compare the performance of various commercially available automated sample extraction platforms and their ability to generate quality nucleic acids for library preparation• Carry out validation studies to optimize new materials for use in the library preparation protocol of the IVD oncology NGS sequencing assay in development and improve internal workflows to ensure best performance• Execute and coordinate cross-functional bridging studies and analyses between Development and Bioinformatics colleagues from different sites• Proficient in Illumina systems operations; hands-on in NGS library construction and quality control using Illumina’s MiSeq, NextSeq, NextSeqDx, and NovaSeq systems• Train new employees and cross-departmental colleagues; generated training videos using an innovative, interactive, real-time conference-based method which effectively trained multiple new employees on a 5 day workflow with COVID-19 distancing precaution• Manage junior scientists with the aim to develop skills in laboratory techniques, study design, data analysis, presentation, and other career development skillsets• Create various plugins and templates using JSL or VBA with file/format conversion, error correction, and trimming capabilities to maximize user friendliness, error proofing, and compatibility with NGS bioinformatics pipeline• Created a centralized inventory for over 1700 FFPE blocks with consented patient and location information in an organized fashion with sequencing/mutation data Show less

Pleasanton, California, United States

• Performed feasibility, optimization, and proof-of-concept experiments for a target capture method to enrich for nucleic acids in bacterial and fungal species in blood• Designed and performed feasibility and proof-of-concept experiments for DNA/RNA extraction from bacterial and fungal species in whole blood to be transferred to a fully automated sample extraction and amplification platform• Designed and performed assay feasibility and optimization experiments to develop an IVD, high… Show more • Performed feasibility, optimization, and proof-of-concept experiments for a target capture method to enrich for nucleic acids in bacterial and fungal species in blood• Designed and performed feasibility and proof-of-concept experiments for DNA/RNA extraction from bacterial and fungal species in whole blood to be transferred to a fully automated sample extraction and amplification platform• Designed and performed assay feasibility and optimization experiments to develop an IVD, high throughput, and fully automated RT-qPCR rapid sepsis detection and identification assay in blood on the cobas® 68/8800 Systems• Present findings at high level cross-functional project team meetings, internal and external meetings, and hold regular companywide seminars Show less

Pleasanton, Ca

• Participated in the research and development of cobas® ADCY9 Genotype Clinical Trial Use (CTA) and IVD level qPCR Assay for cardiac patient companion diagnostic use with leader role in conducting large scale feasibility studies• Independently planned and carried out oligo design, screening, optimization, and guardbanding feasibility studies for development of multiple CAP-CLIA/RUO RT-qPCR Assays detecting RNA fusions and exon skipping for lung cancer diagnostics. Transferred and provided… Show more • Participated in the research and development of cobas® ADCY9 Genotype Clinical Trial Use (CTA) and IVD level qPCR Assay for cardiac patient companion diagnostic use with leader role in conducting large scale feasibility studies• Independently planned and carried out oligo design, screening, optimization, and guardbanding feasibility studies for development of multiple CAP-CLIA/RUO RT-qPCR Assays detecting RNA fusions and exon skipping for lung cancer diagnostics. Transferred and provided on-site field training to CAP-CLIA colleagues offsite• Designed and performed feasibility and proof-of-concept experiments for a method to concentrate of exosome-containing conditioned media from cell lines• Designed original, high performance primers/probes for droplet digital PCR and amplicon-based NGS for use as reference methods for various RT-qPCR assays• Collaborated and communicated closely with cross-functional teams such as Business, Systems, Manufacturing, Operations, Quality, and Regulatory • Managed 2 intermediate level scientists with the aim to develop skills in study design, data analysis, presentation, and other career development skillsets• Drafted and approved various feasibility reports, instruction for use (IFU), manufacturing records, filling/packaging records, and quality control SOPs, and design history documents• Created various plugins and templates using JSL in JMP or VBA in Excel to increase accuracy and efficiency in data import and analysis in large scale studies Show less

Pleasanton, Ca

• Participated in design input research and assay development of an IVD cobas® EZH2 Mutation Detection qPCR Kit for lymphoma diagnostic use; independently designed and performed assay optimization and guardbanding experiments• Worked independently in the development of an updated RUO cytomegalovirus (CMV) qPCR assay on an automated PCR c6800 platform • Completed proof-of-concept testing to expand the CMV qPCR assay to use additional sample types such as urine and saliva to allow for… Show more • Participated in design input research and assay development of an IVD cobas® EZH2 Mutation Detection qPCR Kit for lymphoma diagnostic use; independently designed and performed assay optimization and guardbanding experiments• Worked independently in the development of an updated RUO cytomegalovirus (CMV) qPCR assay on an automated PCR c6800 platform • Completed proof-of-concept testing to expand the CMV qPCR assay to use additional sample types such as urine and saliva to allow for easier sample collection in Genentech clinical study with neonates• Trained 1 student intern with laboratory techniques, experimental designs, data analysis, presentation, and career growth discussions Show less

Fremont, Ca

• Designed validation plans and conducted company wide study efforts to rapidly investigate and successfully mitigated the failure of IVD therapeutic drug monitoring assay reference standard products which caused worldwide performance issues• Project Leader in cross department process and material validation studies to design, manufacture, qualify, and incorporate benchmark anchor/master calibrators into various therapeutic drug monitoring (TDM) IVD immunoassays• Project Coordinator to… Show more • Designed validation plans and conducted company wide study efforts to rapidly investigate and successfully mitigated the failure of IVD therapeutic drug monitoring assay reference standard products which caused worldwide performance issues• Project Leader in cross department process and material validation studies to design, manufacture, qualify, and incorporate benchmark anchor/master calibrators into various therapeutic drug monitoring (TDM) IVD immunoassays• Project Coordinator to design and conduct process validation studies to troubleshoot issues in various products; conducted troubleshooting and investigations to analyze causes of product failures and to design product recovery and corrective actions for various IVD immunoassays. • Experience in handling various formal processes including customer complaints, recording non-conformances, drafting/executing CAPAs, drafting validation/verification studies, addressing FDA concerns and audits• Transferred knowledge of various protocols from colleagues in a 3 week long training in Indiana and effectively cross trained various departments upon return • Knowledge in and compliance to ISO13485 and FDA 21 CFR Part 820 regulatory rules for pharmaceutical products and medical devices• Drafted over 400 new SOPs for new raw materials and/or updated QC documents to capture protocol changes in various IVD products Show less

Fremont, Ca

• Performed confirmation testing of raw materials to ensure performance of final products in clinical diagnostics • Designed and executed official cross-departmental material validation testing plans/studies to assess for changes in product performance with new materials and to implement new materials for use in IVD products

Pleasanton, Ca

• Performed feasibility and optimization experiments in the development of an IVD RT-qPCR test to detect vascular endothelial growth factor subtypes in lung tissues for companion diagnostics• Executed assays in high-throughput format by creating custom Biomek liquid handling system protocols using VBscript• Created data import/analysis VBA Excel macros to increase accuracy and efficiency

Hayward, Ca

• Participated in the development of a simultaneous DNA/RNA/miRNA extraction product suitable for frozen and FFPE tissues • Mastered intraocular injection techniques on murine eyes and other surgical techniques; specifically trained from collaborator in Texas and effectively cross trained colleague groups upon return for further research experiments• Designed and conducted quantitative, fluorescence cell-based assays for calcium-rich cell line validation and quality control; drafted… Show more • Participated in the development of a simultaneous DNA/RNA/miRNA extraction product suitable for frozen and FFPE tissues • Mastered intraocular injection techniques on murine eyes and other surgical techniques; specifically trained from collaborator in Texas and effectively cross trained colleague groups upon return for further research experiments• Designed and conducted quantitative, fluorescence cell-based assays for calcium-rich cell line validation and quality control; drafted formal QC SOPs for the validation and quality control for formal product release Show less

Pleasanton, Ca

• Performed whole genome high-throughput DNA amplification to develop a quantitative qPCR RUO assay to quantify DNA methylation in human FFPE tissues• Utilized high-throughput liquid handling systems to carry out experiments by programming custom methods using VBscript for Biomek Systems Software

Irvine, Ca

• Conducted research on interactions of dopamine D2 receptor with G protein subtypes upon signal influences by detecting multi-DNA/protein targets with in-situ hybridization and immunohistochemistry • Conducted research on potential multi-meric activation induced cytidine deaminase (AID) in antibody diversification and protein-protein interactions of cell death protein FADD with autophagy protein atg5

San Diego, Ca

• Conducted research on the role of ATP and adenosine on T cell function using techniques such as ELISA, SDS-PAGE, and flow cytometry with minimal supervision• Developed protocols to quantitatively and spatially measure real-time calcium level changes in T cells using fluorescence microscopy

Ms, Biological Sciences

Bs, Biochemistry & Cell Biology; Psychology (Biopsychology/Signal Transduction)