Jason Byron Chamberlin
Expert in Bioanalytical Lateral Flow Assays & Formulations
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About
Results-driven Senior Laboratory Technician with over 20 years of experience managing high-throughput testing environments, optimizing analytical workflows and mentoring junior staff. Proven expertise in maintaining regulatory compliance, instrument troubleshooting, and advanced assay execution. Expert in testing of Lateral Flow Assays intended to detect the presence (or absence) of a target analysts in sample (matrix).
Expert in advanced troubleshooting of automated analyzers, complex assay validation, and rigorous statistical quality control management. Advise and assist in the preventive maintenance of lab equipment in clinical environments.
Experience
Senior Mfg/Research Associate - Chromacode
(2020-08 - 2026-07)
- Reagent Preparation: Mixing and blending chemical and biological components for molecular productions
- Product Testing: Running and evaluating high-definition PCR (hDPCR) assays and genomic workflows
- Data Analysis: Recording test metrics, checking quality control standards, and troubleshooting formulation adjustments
- Collaboration: Partnering closely with scientists, molecular biologists, and quality teams
- Leadership & Training: Project Management, coordinate daily work schedules in lab and train junior team members
- Quality & Testing: Conduct advanced chemical, biological, or physical tests, analyze complex data sets, and enforce quality control standards with strict adherence to SOPs while working in GMP laboratory environments
- Operations & Safety: Manage inventory and supply orders, maintain compliance with safety regulations, and write or update SOPs
- Maintenance: Oversee equipment calibration, routine servicing, and troubleshooting
- Expert in Analysis and Management of Lab Equipment: Spectrophotometers, chromatographs (HPLC/GC), pH meters, and electronic balances
- Sample Processing: Centrifuges, pipettes, autoclaves, and nucleic acid extractors, microscopes, laminar flow hoods, incubators for sample builds, Spectrophotometers, Gas Chromatographs and High-Performance Liquid Chromatographs
- Extraction Expert: Core analytical, separation, and molecular assays, relying heavily on daily liquid-liquid extraction, solid-phase extraction (SPE), and nucleic acid/protein extractions to isolate target analysts from complex matrices
- Data Systems: Laboratory Information Management Systems (LIMS) and specialized data analysis sortware including ChromaCode Cloud, Labguru and SciNote
- Advanced Knowledge Of: Data analysis reports for corrective and preventive actions (CAPAs) evaluating quality system performance, recurrence rates, and resolution timeliness
- Resolution and Prevention Diagnostics: Root Cause Analysis, focused on examining data and test results used to identify the fundamental, core reason for pass/fail data
- Project Management: Focus on team understanding and workflows using the following core competencies: Scope definition, resource allocation, and risk management while coordinating with cross-functional scientists, track experimental timelines, and maintain compliance standards
Manufacturing Technician - Illumina
(2019-01 - 2020-08)
- Product Formulation: Formulated custom DNA/RNA oligos and PCR primers, calculating buffer volumes from nanomole yields to produce stable 100 μM stock solutions
- Executed: IQ, OQ, and PQ protocols for manufacturing and assembly lines to guarantee quality control and adherence to ISO and FDA standards
- Tools and Documentation: FMEA, Root-Cause Analysis, Validation Master Plans (VMP) used for project analysis
- Project Management: Focus required balancing hands-on scientific work with core project management strategies: planning scopes, tracking timelines, and allocating resources
- Expertise: Access NGS workflows high-throughput next-generation sequencing (NGS) and advanced biochemical assays for reagent manufacturing and product development
- Managed Sample Tracking: Handled the preparation, quantification, and quality control of DNA/RNA libraries under tight production timelines
- Validation: Finished goods representative sample collection, executing physical, chemical, or microbiological evaluations using calibrated equipment documenting results
- Sample Handling: Preparation, quantification, and quality control of DNA/RNA libraries under tight production timelines
- Advanced Knowledge of: NovaSeq X Series & NovaSeq 6000, High-capacity production systems/MiSeq Series (including MiSeq i100): Compact benchtop lab sequencers built for targeted and small genome sequencing/iScan System: Microarray scanner utilized for high-throughput genetic variation and genotyping screening
- Managed: Supply and inventory tracking and forecasting for production planning
- Focused On: Current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs) for all testing and data recording
- Mentored and Trained: New lab technicians and junior associates on safety protocols, lab techniques and equipment
- Strict Adherence to: Standard Operating Procedures (SOPs) and management requiring a structured framework focused on safety, precision, and maintaining strict documentation on all assigned project builds
Manufacturing Technician - Grifols
(2015-02 - 2019-01)
- Responsible For: The manufacture of bulk clinical and commercial kit reagents including EP/USP, GMP grade and diagnostic grade human plasma proteins
- Managed: Weighs, measures, and checks raw materials and/or manufacturing parts to assure that batches manufactured contain proper ingredients and quantities
- Authority In: The compound bulk production, filling, aliquoting, and packaging of material into the final product
- Communications: With Program Director and Planners with updated process on all fill projects
- Project Management: Incorporated project management focused on process ownership, cross-functional tracking, and process execution
- Subject Matter Expert: Bulk/Fill process - interacting with Manufacturing Sciences to assist with product transfer and investigations
- Specialized In: In process visual inspection and sample gathering of temperature-sensitive semi-finished goods for use in blood screening kits
- Understanding: Executing written procedures in accordance with cGMP
- Performs labor transactions: Using the Enterprise Resource Planning (ERP) System
- Proficient Use Of: Gri-Fill 4: Closed, semi-automatic compounding and filling device/Sterile Filling (GSF): A specialized aseptic liquid dosing and filling technology/KIRO Fill: Automated robotic technology engineered for the batching and sterile syringe-filling
TFZ Fill Lab Tech - Hologic
(2014-05 - 2015-02)
- Reagent Filling & Formulation: Operate automated or semi-automated dispensing and filling equipment for clinical and commercial diagnostic kits
- Documentation & Compliance: Complete batch records and manufacturing logs accurately while maintaining strict adherence to Good Manufacturing Practices (GMP) and ISO 13485 guidelines
- Equipment Maintenance: Perform equipment setups, routine cleaning, and basic calibration of laboratory filling and dispensing instruments
- Quality Control Support: Monitor yield performance, check product weights/volumes for consistency, and report any process deviations to shift supervisors
- Inventory & Safety: Track material requisitions, cycle count production components, and follow all safety protocols in a lab or cleanroom environment
IPT Clinical Lab Tech - Alere
(2009-01 - 2014-05)
- Performed: Complex diagnostic molecular, immunoassay and blood sample testing according to strict standard operating procedures (SOPs)
- Managed and Prepared: In-process biological or chemical specimens with high accuracy
- Advanced Knowledge Of: Cardio Product Line/TOX Drug Panel and Blood Sample testing, data processing and analysis
- Expert: In-Process, Stability, Method Validation and Final Release Testing
- Tracked and analyzed trends for Final Release: Involved gathering quality control data, plotting results on control charts, and reviewing metrics
- Troubleshoot assay performance issues or equipment malfunctions when results fall out of range
- SOP and Document Management: Manage test process and project inventory control through SOP management
- Workflow Coordination: Across shifts to ensure timely processing of diagnostic batches, testing and processing and timely analysis of data
Education
Psychology - Moorpark College
University of California @ San Diego