James E. Cherwa, Jr.
Salt Lake City
Summary
7+ years of experience in in-vitro diagnostics (IVD) and molecular testing, specializing in assay development, optimization, and testing procedures, troubleshoot issues, and ensuring adherence to regulatory standards. Spearheaded transfer of 20+ multiplex assays from Research and Development (R&D) to Operations, optimizing processes and enhancing continuous improvements. Conducted validation and verification studies to evaluate and optimize assay performance, ensuring the completion of written reports and documentation.
Overview
14
14
years of professional experience
Work History
Manager, Product Support
BioGX, Inc.
02.2021 - 06.2024
- Developed the Product Support department, hiring and training five applications specialists.
- Source for diagnostic test and molecular control inquiries for assay compatibility with numerous sample types, RNA/DNA extraction methods, and troubleshooting 8+ different qPCR open systems platforms. Duties included training, product presentations, and literature reviews.
- Collaborated with cross-functional teams for assay development and following emerging technologies, achieving 100% of annual corporate and department goals for each year.
- Designed, executed, and oversaw experiments, experimental data analysis, and resolution of over 100 customer complaint investigations and reports, maintained the CRM, and ensured the completion of CAPA investigations.
- Supported CLIA/CAP certified laboratories with implementation of 80+ multiplex qPCR IVD diagnostic tests.
Technology Transfer Project Manager
BioFire Diagnostics (bioMérieux)
08.2020 - 02.2021
- Ensured regulatory compliance across projects, enhancing team collaboration and project success.
- Completed key Quality Control projects, contributing to departmental achievements.
Manager, Product Delivery (Operations/R&D)
BioGX, Inc.
02.2019 - 08.2020
- Supervised components of R&D Product Transfer and Operations Reagent Production and Quality Control, a team of 16 direct reports with positions ranging from Ph.D. Scientists to Manufacturing Technicians.
- Led the COVID-19 response, balancing resources and accelerated timelines to meet surge in pandemic demand, increasing production capacity by a factor of five.
- Recruited and mentored staff, fostering skill development and improving overall departmental performance and employee retention.
Managing Scientist, Research and Development
BioGX, Inc.
02.2018 - 01.2019
- Ensured product performance criteria were consistent with our Quality Management System (QMS), cGMP/GDP guidelines, FDA, CE, and ISO 13485 standards for the design, development, manufacture, and distribution of in-vitro molecular diagnostics (IVD).
- Led product development projects, designed protocols, and executed experiments to refine qPCR master mix formulations and drive product design improvements.
- Spearheaded product transfer of 20+ multiplex assays from R&D to Manufacturing, optimizing processes and enhancing continuous technical operations improvements.
- Conducted validation/verification studies to evaluate and optimize product performance, ensuring the completion of written reports and documentation.
- Exercised methods and trained team members on standard microbiology and molecular biology laboratory techniques including aseptic technique, sample processing, nucleic acid extraction, qPCR, gel electrophoresis, etc.
- Optimized large-scale formulation assembly protocols, adhering to cGMP/cGDP and ISO 13485 standards, implemented lean manufacturing processes, resulting in measurable improvements in throughput and scalability.
Scientist, Reagent Manufacturing
BioGX, Inc.
03.2017 - 01.2018
- Supervised components of R&D Product Transfer and Operations Reagent Production and Quality Control, a team of 16 direct reports with positions ranging from Ph.D. Scientists to Manufacturing Technicians.
- Led the COVID-19 response, balancing resources and accelerated timelines to meet surge in pandemic demand, increasing production capacity by a factor of five.
- Recruited and mentored staff, fostering skill development and improving overall departmental performance and employee retention.
Biology Instructor
Central Alabama Community College
08.2013 - 03.2017
- Developed detailed syllabi and lesson plans for Biology and Microbiology courses.
- Implemented an NSF-funded Directed Studies course, providing valuable research experiences.
- Authored a textbook for Principles of Biology, improving learning materials.
Postdoctoral Associate
University of Alabama at Birmingham
02.2011 - 07.2013
- Conducted research and innovative studies to elucidate virus assembly mechanisms. Utilized technical writing skills and statistical analysis to publish manuscripts.
- Utilized molecular biology, microbiology, biochemistry, and microbial genetics techniques.
Postdoctoral Associate
University of Arizona
01.2010 - 01.2011
- Managed lab operations, laboratory instrument maintenance, and inventory oversight.
- Pioneered novel in-vitro assembly system for bacteriophage phiX174, opening new avenues for the investigation of virus assembly.
Education
Doctor of Philosophy (Ph.D.) - Microbiology
University of Arizona
Tucson, AZ12.2009
Bachelor of Science - Microbiology/Chemistry
University of Arizona
Tucson, AZ12.2006
Skills
- Molecular Biology, Microbiology, Biochemistry, In-vitro Diagnostics (IVD), qPCR, Research and Testing Methods, Regulatory Compliance, Research and Development, Quality Management System, ISO 13485, Written and Verbal Communication Skills, Technology Transfer, Scientific Method, Ability to Prioritize, Time Management, Operations Management, Quality Assurance, Assay Development, Data Collection and Analysis, Technical Writing, Quality Control, Nucleic Acid Extraction, Product Management, Process Improvements, Product Delivery, Cross-Functional Team Collaborations
Timeline
Manager, Product Support
BioGX, Inc.
02.2021 - 06.2024
Technology Transfer Project Manager
BioFire Diagnostics (bioMérieux)
08.2020 - 02.2021
Manager, Product Delivery (Operations/R&D)
BioGX, Inc.
02.2019 - 08.2020
Managing Scientist, Research and Development
BioGX, Inc.
02.2018 - 01.2019
Scientist, Reagent Manufacturing
BioGX, Inc.
03.2017 - 01.2018
Biology Instructor
Central Alabama Community College
08.2013 - 03.2017
Postdoctoral Associate
University of Alabama at Birmingham
02.2011 - 07.2013
Postdoctoral Associate
University of Arizona
01.2010 - 01.2011
Bachelor of Science - Microbiology/Chemistry
University of Arizona
Doctor of Philosophy (Ph.D.) - Microbiology
University of Arizona
Awards
BioGX President's Club Award, 2018 (the company’s highest recognition), BioGX Excellence Award, 2017, University of Arizona Ph.D. Centennial Award, 2009
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