John Middleton Email & Phone Number

California, United States

San Diego County, California, United States

• Amprion, Inc. is developing and commercializing novel technologies for diagnosing neurological disorders.Spearheaded strategic initiatives in project management, system engineering, data analytics, technical.
• Championed commercialization strategy by directing SYNTap® qualitative α-synuclein assay development from clinical laboratory transfer to market readiness.
• Architected and implemented comprehensive FDA-compliant design controls, risk management and software validation frameworks, establishing robust product development process.
• Orchestrated Critical Design Reviews across development phases, securing 100% stakeholder consensus for strategic project advancement.
• Engineered sophisticated patient classification algorithms, achieving industry-leading >90% assay accuracy rates.
• Designed and deployed assay data analysis software, delivering >10-fold efficiency gains and dramatically enhancing project agility.

San Diego, California, United States

• Product Development Project Manager
• Lead implementation of Design Controls and Risk Management for Product Development
• Validation protocols and reports
• Scientific publications
• Experimental design
• Data analysis including software development

• Qualigen, Inc. manufactures medical equipment for measuring thyroid-stimulating hormone, free T4, human chorionic gonadotropin, PSA, free PSA, vitamin D, SHBG, and testosterone in blood.Led diverse cross-functional.
• Directed comprehensive CLIA Waived device development lifecycle from Viability through Verification phases, orchestrating internal teams and external resources.
• Developed comprehensive Design Input requirements incorporating human factors engineering principles, establishing detailed software specifications for advanced assay mathematics and statistical analysis.
• Authored and secured approval for Risk Assessment and FDA pre-submission documentation supporting CLIA Waiver application.
• Orchestrated seamless coordination between external design house and internal technical teams, driving software/hardware development, system optimization, and verification processes.
• Invented and secured primary patent (US9903799B2) for innovative quantitative, lateral flow-based blood separation technology.

Brea, California

• Beckman Coulter Inc. is a Danaher Corporation company that develops, manufactures, and markets products that simplify, automate and innovate complex biomedical testing.Drove product development and production support.
• Key contributor to integration and verification for multiple flagship platforms, including CX3, CX4/5, CX7, DxC, LX20, and LabLyte systems.
• Established organizational authority on calibrator/control value assignment and advanced data analytics.
• Directed successful development and commercialization of strategically important Immage Cystatin C immunoassay.
• Spearheaded high-sensitivity CRP standardization initiative, delivering full-scale implementation.
• Pioneered spectroscopic parameter optimization process for Valproic acid assay, achieving ~30% improvement in assay precision.

Masters Program Chemistry Work (Coursework Complete, Thesis Incomplete)

Bachelor Of Science - Bs, Chemistry