Continuous Improvement Clinical Trials

LYNN DENG, Ph.D.

******@*****.*** 747-***-**** LinkedIn.com/in/lynn-deng-37bb7aa Porter Ranch, CA 91326

SUMMARY

Talent Professional with more than 10 years’ experience in biomarker assay development and validation, drug discovery, and regulatory / compliance to support biologics manufacturing and clinical trials. Take proactive approach and continuous improvement mindset to achieve corporate objectives. Known for high performance and a team player across functional areas. Love challenge and learn new technology advancement to prepare for the next assignment. Expertise in:

PQ automated instrumentation Biologics Manufacturing Laboratory Operation

Clinical Trials Biomarker Assay Development Regulatory Submission

Protein Purification LDT Assay Validation Project Management

Companion Diagnostics Preclinical Drug Discovery NCs and CAPA

Quality Management System cGMP / GDP / GLP / GCP Inspection / audit

Oncology Molecular Test Nucleic Acid Extraction Compliance

Problem Solving Investigation / Write Report Quality Improvement

PROFESSIONAL EXPERIENCE

Takeda Pharmaceuticals, Thousand Oaks, CA 08/2022 – 12/2023

Sr. Compliance Investigator/Manufacturing Support

The Compliance Investigator conducts root cause investigations, closes deviations, supports assignment of proper corrective actions, and facilitates implementation for Manufacturing under the direction of Compliance Management.

Performed data calculation, collection, and trending to support manufacturing process parameter evaluation in support of site continuous improvement (CI) initiatives.

Evaluated and extracted information from SOP and validation of equipments and assays to support testing, re-testing, and investigation reports for Thousand Oaks Manufacturing facilities.

Used tools (TrackWise, camera, LIMS, DMAIC, 6M in combination) to collect data and information and interviewed involved personnel to prepare investigation report; worked with Quality Assurance (QA) and Manufacturing supervisors and managers to close investigation and execute CAPA.

Assisted Compliance Supervisor in updating department metrics, participating QWTs and tiered meetings, and leading daily operations to ensure coordination and efficiency.

Participated in deviation related team meetings and provided feedback, leadership, and support to manufacturing supervisors, trainers, and manufacturing operators on the status of compliance investigations to ensure timely release of product for customers.

Communicated and enforced training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs and EHS regulations.

Conducted prompt, thorough, and fair investigations comprising of deviation verification, investigative interviews, and kickoff meetings in partnership with Manufacturing, Quality Assurance, Quality Control, Engineering Maintenance, HR, Training, Logistics, Security, and Vendors in local region and cross-region globally.

Monitored, evaluated, and determined the effectiveness of corrective and preventive actions.

Participated with quality and management teams to drive continual improvement by sharing lessons learned and maintaining effective and open communications.

PerkinElmer, CDPH Branch Lab, Valencia, CA 10/2020 – 05/2022

Sr. QA Engineer Lead

Designed instrument performance qualification (PQ) experiments to ensure following IQOQ, specific protocols were executed as planned at functional level such that validation of assay is ready. To automated workflow of SARS-CoV-2 assay, each instrument from extraction to PCR owns evidence-based PQ results to certify it in response to installation, repair, software upgrade. Tracked instrument IQOQPQ status to meet clinical testing schedule and demand to meet TAT and surge in testing volume.

Maintained instrument inventory including Janus Reformatter, Chemagic 360-D, Janus qPCR, and AJ Thermocycler (total 189) and miscellaneous accessories, and tracked IQOQPQ status of each instrument for SARS-CoV-2 assay for operation, audit, instrument service, and asset purposes.

Participated in external audits (LFS, CMS, CAP), internal audits, audit-ready preparedness trainings, audit reports, and CAP accreditation and deficiency response; took charged of CAP survey sample testing and passed 100% in years of 2020, 2021, and 2022; mentored junior QA by commenting on SOP revision and by shadowing end-to-end tracer audits, sharing instrumentation details to help QER investigations/CAPA involved from operation, result reporting, to customer complaint.

Provided feedback to management and instrument service team to implement cherry picking (repeat testing), PKEye (investigation), new version of Janus protocols (water volumetric testing prior to LOD PQ) to reduce contamination and run time; PCR thermocycling condition lockdown, limitation of instrument software access to Janus Reformatter, to enhance quality and security and to be compliant with CLIA regulation.

Communicated with medical director, site leaders, departments of accession, extraction, PCR, data analysis, and LIMC to assure SOP being followed, corrective actions in response to audits being implemented and completed, and elevated issues when needed.

Led 6-month and 12-month competency project by introducing sample randomization, coordinated competency sample preparation, tabulated results to allow evaluation of performance, and reviewed competency forms for completeness and accuracy; designed and led eight Decapper PQ for five different tubes of dry and wet swabs, and coordinated with instrument service team for its IQOQ and learned UOQ to report IQOQPQ results.

QUEST DIAGNOSTICS, Valencia, CA 03/2009 – 12/2019

Scientist, Medical Affairs, 01/2018 – 12/2019

Acted as a clinical operation team player by coordinating and collaborating with internal and external customers on clinical trials and companion diagnostics projects at CRO capacity, followed up and followed through on key issues, helped with troubleshooting and process improvement via timely communication and keeping abreast of current technology.

Acted as scientific and clinical expert and liaison between Quest and Q2 Solutions during transition to joint venture to help Q2 Solutions make informed decision on proprietary PCR tests, SOP harmonization, maintained uninterrupted workflow of new test pipelines and smoothed operation among laboratories to meet timeline of assay transfer and regulatory submission.

Provided technical support and technical transfer to Technical Service, Project Management, and Molecular teams to execute equipment IQ/OQ/PQ, assay validation, stability study, and assay transfer; improved process and test quality to reduce turnaround time and cost; used proper cell lines and tissues for sensitivity and reproducibility to improve quality, in charge of review and approval process, acted as subject matter expert for test and kit knowledge.

Managed timeline, milestones, deliverables and regular updates from SOP (LDT assays), validation report to support decision making and clinical trials, and responded verbally and in written format to NY state regulatory agency and healthcare / pharmaceutical professionals.

Supported test transfer and companion diagnostics projects including HLA-1A, 1B, 1C, DQA1, DQB1, and DRB1 genotyping, pharmacogenetic tests CYP2C9/VKORC1, CYP2C19, CYP2D6, and UGT1A1, IDH1 (NGS), DNA and RNA extraction from FFPE tissue, blood (serum and plasma, automated Hamilton Microlab STAR and Tecan plate reader), bone marrow, and sperm.

Participated in medical directors’ oncology congresses to support medical diagnostic strategy and learned progress from oncology medical leads about planning and execution.

Kept current knowledge of cancer treatments and healthcare evolution via conferences, webinars, journals, promotional materials, kit package inserts, and publications including internal test updates, manuscripts, abstracts, posters, and Clinical Education Program of Quest Diagnostics, Medical Affairs.

Teamed up with medical device partners to seek partnership to drive oncology research and published results (e.g. 2019 AMP abstract with Agena Biosciences).

Clinical Development Scientist, R&D, 01/2014 – 12/2017

Collaborated with Pharma Company on new test development and global study. Performed validation from end to end by modifying FDA approved oncology molecular tests or using a RUO or LDT tests to meet CLIA regulation and reach the highest standard as necessary.

Led and completed validations including therascreen® EGFR mutation, cobas® EGFR mutation, cobas® BRAF mutation, cobas® PIK3CA mutation, TaqMan based FGFR4 CNV, FGF2 CNV re-activation, and helped transfer assay to global lab.

Completed QMS training (Kaizen) and worked on a project to reduce residual sample loss.

Worked with PM and Novartis scientists and database teams on data Transfer Specification (DTS) for Biomarker panel studies involved copy number and sequencing for clinical data analysis.

Acted as North America coordinator for a global KRAS / BRAF / NRAS mutations panel study for China’s BeiGene (phase 1B), ensured efficient sample transfer, testing and reporting of results, monitored to ensure TAT were met, identified problems, investigated, recommended solutions, and implemented them.

Prepared New York submission / response and received approval for BRAF / KRAS / NRAS SNAPshot multiplex assay; assisted NY inspection; performed production, data trending, training, alternative performance assessment, scaled up cell cultures for preparing FFPE mutation quality controls for oncology molecular assays.

Knowledge of CRISPR via a course “Principles and Practices of Gene Therapy (XGEN201)” from Stanford’s Genetics and Genomics certificate program.

Biomarker Development Scientist, Clinical Trials, 09/2009 – 12/2013

Conducted laboratory developed test (LDT) qPCR validation experiments for various types of clinical samples using commercially available reagents and top-notch instruments to support business units through the entire business cycle to gain repeat business.

Assisted test cost for bids (RFTS), equipment IQ/OQ/PQ, performed feasibility study and validation bench work, wrote validation plan, report, and SOP including acceptance criteria, tissue and software algorithm, instrument parameters for automatic mutant calling, and reporting guideline; validated test codes on database, computer algorithm adjustment, QC and proofread clinical trial documents, and trained CLS and operators for production, prepared power point slides for business presentation.

Led efforts to develop new biomarker assay, BRAF/KRAS/NRAS multiplex SNaPshot mutation assay, with Merck scientists for their clinical trial.

Designed and executed validation for LDT and RUO tests including four copy number variation (CNV) assays (FGFR1, FGFR2, FGF2, FGFR3, FGF3) for Novartis, telomere length assay, and BRAF/KRAS/NRAS multiplex SNaPshot mutation assay, DxS KRAS and EGFR mutation assays.

Collaborated with Novartis scientists on CNV projects by using their cell line DNA to be verified as positive and negative controls during clinical trials, performed instrument maintenance and calibration.

Participated in study start / execution / close-out meetings with PM and clients to discuss scope of work, proof-read document, drafted meeting agendas and minutes, performed clinical data review and data analysis, updated progress at team meetings.

Published an abstract titled “Comparison of PTEN protein loss to PI3K gene mutation status in breast cancer” in AACR Molecular Diagnostics conference.

Test Development Scientist, Clinical Trials, 03/2009 – 08/2009

Managed assay transfer, production, quality and process improvement, and client audit.

Successfully trained on DNA extraction and KRAS (DxS) mutation assay, helped production to meet turn-around time as volumes increased, prepare KRAS validation addendum using new QIAGEN DNA extraction procedure, suggested entries of KRAS Ct values require verification prior to release.

Helped purchase a new ABI 7500 real-time PCR instrument dedicated to KRAS testing with FDA 21 CFR Part 11 to be compliant, cooperated with Merck KRAS audit.

BAXTER INTERNATIONAL, INC., Los Angeles, CA 05/2005 – 03/2008

Consultant, Compliance Specialist, 09/2006 – 03/2008

Engaged in ISR and DCR to support FDA regulatory submission and tracked ER to monitor product delivery and continuous improvement. Monitored manufacturing non-conformance to improve process and quality control through ER & CAPA. General knowledge of GDP, cGMP, CFR, LIMS and Blue Mountain database, and manufacturing protein purification processes for Pharma products Albumin and AHF-M.

Coordinated with manufacturing compliance group, quality, and engineering groups to reduce cycle time by 11 days for Albumin and to reach fulfillment at least 90% for AHF-M and 100% for Albumin.

Integrated information from reviewing AHF-M/APD run sheets, maintenance records, SOP, operator interview, and regulatory document to make sound decision for root cause analysis of exception report (ER) carrying high and critical risks for Albumin/AHF-M departments.

Prepared CAPA assessment reports regarding protein recovery out of range and human errors as the major root causes of exceptions in year 2006.

Consultant, Validation Scientist, 05/2005 – 05/2006

Facilitated assay transfer and product quality control for manufacturing biologics, provided scientific assistance to director, manager and colleagues across functional areas.

Successfully transferred and developed 4 assays for the Bioscavenger Project from Baxter at Vienna R&D facility to Los Angeles manufacturing facility.

Verified and validated assay transfer using Varian HPLC for human plasma protein butyrylcholinesterase (BChE) purity and quantitative analysis of impurities procainamide and p-aminobenzoic acid.

Validated BChE activity assay for in-process samples and final container sample.

INTERSCIENCE INSTITUTE, Inglewood, CA 11/2002; 10/2003 – 02/2004

Chief Chemist

Developed 13 radioimmunoassay (RIA) for hormones and peptides used for clinical samples.

Performed radio-iodination and purification of iodinated small peptide hormones including ADH, amyloid -protein, angiotensin I and II, GIP, LHRH, motilin, neurokinin A, neurotensin, pancreastatin, somatostatin-14, substance P, TRH.

ADDITIONAL EXPERIENCE (University Research)

Cell based assays: cytotoxicity assay, cell proliferation assay, peripheral blood mononuclear cells (PBMC) cell based assay for anti-inflammatory drug screening, performed mammalian cell cultures of solid tumors and blood tumors for anti-cancer drug screening and various tumor and arthritis animal models for preclinical evaluations (UCSD).

Protein purification and analysis for receptor macromolecules and antibodies: Chromatography (HPLC, ion exchange, size exclusion, affinity, protein A purification), SDS-PAGE, Isoelectric focusing, Western blotting, Ca+2 flux assay, receptor binding assay, flow cytometry, filtration, centrifugation

Cytokine ELISA (solid-phase immunochemistry) including TNF, IL-1, IL-4, IL-6, IL-8 and IL-12 in cultured human monocytes supernatant

Prepared buffers, assembled process equipment, performed troubleshooting and data analysis, wrote lab note, participated in lab management (e.g. received chemicals and supplies), 5S of lab area

EDUCATION

University of California, Los Angeles, Ph.D. Pharmacology

University of California, Los Angeles, M.S. Pharmacology

China Medical College, Taiwan, B.S. Pharmacy

CERTIFICATIONS

Time Management Certificate 2023

CAP Inspection Leader training Certificate 2019

Stanford Genetics and Genomics Certificate 2017

Quality Control and Method Validation, ASCP 2009

PATENT

Thiazolopyrimidines Useful as TNFα Inhibitors (for formulation) (US 6,930,101 B1)

TECHNICAL SKILLS

Microsoft (Word, Excel, PowerPoint, Outlook, Visio, Skype, SharePoint), Adobe Acrobat, MediaLab, TrackWise

SOFT SKILLS

Organized, Effective Communication, Curious, Willingness to Learn, Self-motivated

Solution-driven, Can Manage Changing and Competing Priorities, Built Trust and Relationship

A Team Player who is Flexible and Enjoys Collaboration

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