Justin Sinohui Email & Phone Number

Tucson, AZ, US

Tucson, Arizona, United States

Technical experience: Class III IVD assay development, IHC, Design for Six Sigma Green Belt, SAFe methodologiesCurrently serving as an assay development lead as part of an IVD assay development project intended for use as a companion diagnostic (Class III).

Tucson, Arizona Area

Contract position at Roche Tissue Diagnostics providing technical services in support of an IVD assay development project (IHC).

Tucson, Arizona Area

• Technical Experience: Complex manufacturing, automated data collection and analysis using Python, basic microbiology techniquesServed as a technical resource for the consumable manufacturing team involving the.
• Oversaw complex manufacturing processes involving multi-step formulations, provided hands on training and technical guidance to associates, and represented operations as part of… Show more Technical Experience: Complex.
• Oversaw complex manufacturing processes involving multi-step formulations, provided hands on training and technical guidance to associates, and represented operations as part of continuous improvement efforts
• Provided laboratory based and data analysis based technical support to product performance investigations, non-conformance resolution, and CAPA efforts Show less

Tucson, Arizona Area

• Technical experience: Mechanically sound project schedule development, project schedule analysis, project risk assessment and analysisManaged IVD assay development projects and complex design change projects for the.
• Responsible for the management of project information, establishment of the project schedule, and the monitoring & controlling of ongoing project work
• Participated on a broad range of diagnostics assay project… Show more Technical experience: Mechanically sound project schedule development, project schedule analysis, project risk assessment and analysisManaged IVD.
• Participated on a broad range of diagnostics assay project types covering the full product development process, including involvement on several molecular assays with varying degrees of complexity (i.e. Class III PMA.
• Contributed to the deployment of a Roche divisional level project risk management realignment initiative at Ventana Show less

Carlsbad, CA

• Technical experience: IVD Manufacturing, software verification & validation, AC voltammetry, multiplexed PCRSupervised and mentored a team of QC & Formulations Specialists tasked with the formulation and QC testing of.
• Responsible for the tactical management of QC and production resources as part of a manufacturing organization in its growth-phase
• Handled issue review & resolution, process… Show more Technical experience: IVD Manufacturing, software verification & validation, AC voltammetry, multiplexed PCRSupervised and mentored a team of QC & Formulations.
• Handled issue review & resolution, process optimization & design change, and capacity planning
• Established the framework for a team-wide approach to process improvement that delivered significant and sustained gains in operation efficiency and throughput
• Realized a significant reduction in QC time and reduced human errors by facilitating the transition from a manual to an automated process for the analysis and reporting of QC results by closely partnering with the.

Branford, CT

• Technical experience: Pyrosequencing, DNA & Protein coupling to activated microspheres, colorimetric & chemiluminescent enzymatic assays, PCR, flow cytometryUsed a hands-on approach to lead a team of Manufacturing.
• Encouraged deep process understanding throughout the team and maintained a technical projects program that was aimed at inquiry… Show more Technical experience: Pyrosequencing, DNA & Protein coupling to activated.
• Encouraged deep process understanding throughout the team and maintained a technical projects program that was aimed at inquiry, process standardization, and continuous improvement
• Highly active in the CAPA process, product transfer projects, the creation and revision of production documentation (SOP), and process design, characterization, & validation projects
• Partnered with the R&D department to contribute to key projects including test method development and next generation system development Show less

Tucson, Arizona Area

• Technical Experience: Small team Leadership, production scheduling, manual processes for reagent fill and kit packProvided the first level of leadership on an integrated reagent manufacturing team that served a broad.
• Maintained production plans and processes in a regulated (GMP compliant) work environment
• … Show more Technical Experience: Small team Leadership, production scheduling, manual processes for reagent fill and kit packProvided the first level of leadership on an integrated reagent manufacturing team that.
• Contributed to production scale up efforts for DNA isolation and purification processes Show less

Tucson, Arizona

• Technical Experience: Automated ISH and IHC assays, DNA probe labeling, DNA extraction & purification, dye chemistry, small and medium scale formulations (up to 200 L)Completed reagent formulations and performed QC.
• Completed product out of Specification and non-conformance investigations
• Became proficient in reagent formulation techniques and reagent QC strategies
• Introduced to world class… Show more Technical Experience: Automated ISH and IHC assays, DNA probe labeling, DNA extraction & purification, dye chemistry, small and medium scale formulations (up to 200 L)Completed.
• Introduced to world class lean manufacturing principles Show less

Bs, Chemistry

Completed elective upper division level coursework that included courses in instrumental analysis, intermediate organic chemistry.

Non-Degree Seeking Coursework, Topics In Data Science

Completed a three part program in the Foundations of Data Science offered by UC BerkeleyX: Computational Thinking with Python, Inferential.