Assay Development Data Analysis

Peter Ren

*******@*****.*** • 858-***-****

LinkedIn • Escondido, CA 92029

Staff Scientist

Accomplished and innovative Staff Scientist with 20+ years of experience in biotech field.

Proven track record of leading bioconjugation and assay development initiatives. Extensive experience in developing and validating quantitative and qualitative assays. .Adept at identifying innovative solutions to technical challenges and presenting findings to stakeholders. Expertise in analyzing and interpreting experimental data to guide research projects. Skilled at preparing reports and regulatory documentation while ensuring compliance with quality standards. Excel in fostering synergy and achieving project objectives through excellent communication across diverse functional groups.

Areas of Expertise

• Antibody/Protein/small molecule Conjugation

• Biochem/Cellular Assay Development and Validation • Antibody/Protein purification

• Lateral Flow-Based Assays

• Data Analysis & Management • Project Representation

• Regulatory & Standard Compliance

• Cross-functional Collaboration

Technical Skills

Protein Biochemistry: Antibody/Protein/small molecule Conjugation, Recombinant Protein Expression and Purification in Bacteria, Insect Cell and Mammalian Cell, Chromatographic Technology, HPLC, SDS PAGE & 2D-Gel, Western Blot, Immunoprecipitation, ELISA, Antibody-Antigen Interaction, Enzyme Kinetic Analysis, Viral Transfection, Plasmid Transduction.

Molecular Biology: PCR & RT-PCR, DNA Cloning, Site-Directed Mutagenesis, In Vitro Transcription

Testing and Analysis: Lateral Flow Assay (LFA), Microfluidics assay, Immuno-related Assay Development, Transferring to Production

Technological Tools: Microsoft Office suite, JMP, GraphPad/Prism, Visual Basic for Applications (VBA)

Career Experience

QuidelOrtho, San Diego, CA 2006 – 2018 – 2024

Senior/Staff Scientist, Research & Development

Developed quantitative assays of immune biomarkers and optimized quant-assay for immune, cardiac biomarkers by optimizing antibody conjugations and other assay conditions. Analyzed experimental data, interpreted results, and drew conclusions to guide direction of research projects. Utilized statistical tools and software for data analysis. Prepared detailed technical reports, research papers, and regulatory documentation in compliance with quality standards. Led test development initiatives and involved in planning of clinical trials and creation of technical documentation. Presented findings and progress to internal teams and external stakeholders.

• Spearheaded development and validation of multiple FDA approved/510k CLIA-Waived medical devices for infectious diseases, such as Covid, influenza A/B, RSA, Strep A, Mono. Developed and validated Quantitative Vitamin D assay.

• Conceptualized and managed the development of Strep A ultra-sensitive test including involving in clinical trials and preparing technical files for FDA submissions.

• Supported FDA submission for 510(k) and CLIA Waiver and addressed technical inquiries from FDA.

• Earned two US patents by identifying challenges for a top-selling product, leading troubleshooting efforts, and proposing solutions to enhance product performance significantly.

Quest Diagnostics Incorporated, San Juan Capistrano, CA Jun 2004 – Mar 2006

Senior Scientist, Department of Hematology/Oncology

Developed and validated cancer diagnosis assays with ELISA (EIA), multiplex PCR, RT-PCR, SNaPshot, and DNA sequencing technologies. Established standard operating procedures (SOPs) for clinical testing operations. Investigated potential biomarkers for hematological and oncological diseases through molecular profiling, genomics,

• Conducted and validated in-house ELISA test for liver tumor indicator.

• Validated the Breast Cancer Recurrence assay using real-time RT-PCR while ensuring precise and reliable results.

Novartis Institute for Functional Genetics (GNF), San Diego, CA Feb 2004 – Jun 2006

Postdoctoral Research Associate, Department of Cancer and Cell Biology

Carried out research projects on apoptosis of cancer cell lines by developing new cell-based assays and using molecular and biochemical approaches,

• Dissected the signal transduction pathways using cell-based assays with the genomic wide high throughput screening technologies, such as siRNA and cDNA screening and flow-cytometry.

• Identified the antibodies and small molecules that affect cell death.

Additional Experience

PhD Candidate, Department of Molecular and Cell Biology, Uppsala University, Biomedical Center, Uppsala, Sweden

Visiting Scientist, Department of Animal and Genetics, University of Florence, Florence, Italy Research Scientist, Biotechnology Research Center, Chinese Academy of Agricultural Sciences, Beijing, China

Education

PhD, Molecular Cell Biology

Department of Molecular and Cell Biology, Biomedical Center, Uppsala University, Uppsala, Sweden

MS in Cell Biology

Department of Biology, Lanzhou University, Lanzhou, China

BS in Cell Biology

Department of Biology, Lanzhou University, Lanzhou, China

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