Peter Ren Email & Phone Number

Accomplished and innovative scientist with 20+ years of experience in biotech and medical diagnosis fields. Proven track record of leading test development initiatives. Extensive experience in developing and validating quantitative and qualitative assays of immune/cardiac biomarkers, infectious diseases. 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.

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  Scientist

  Quidel Corporation

  Apr 2006 - Mar 2024

  Staff Scientist, R&D 2018-2024Explored developing quantitative assays of immune biomarkers and optimized quant-assay for cardiac biomarkers. 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… Show more Staff Scientist, R&D 2018-2024Explored developing quantitative assays of immune biomarkers and optimized quant-assay for cardiac biomarkers. 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 QV SARS Antigen (professional), QV SARS Antigen at-home,.• Conceptualized and managed the development of Sofia Strep A ultra-sensitive test including involving in clinical trials and preparing technical files for FDA submissions. Patent granted recently.• Successfully facilitated submissions and provided technical support for product applications including Sofia flu and RSV in meetings with Chinese NMPA reviewers and effectively addressed inquiries.Senior Scientist, 2006-2018Developed, validated, and transferred Sofia Strep A, Sofia2 Strep A+. Earned an US patent. Supported FDA submission for 510(k) and CLIA Waiver. Developed and validated Sofia Quant Vitamin D. Reformulated tests of QV Strep A dipstick, Strep A Inline, QV RSV, and QV hCG for large scale manufacturing. Searched for and validated alternative fiber materials for QV products while ensuring continuous production of all product lines for over decadeSenior Scientist, Quest DiagnosisDeveloped and validated cancer diagnosis assays with ELISA, multiplex RT-PCR. Established SOPs. Investigated potential biomarkers for hematological and oncological diseases,• 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. Show less