Mariana C. Gadaleta

Sr Scientist @Illumina

Technical consulting and change process support as part of Product Development supporting On-market sequencing platform consumables (flow cells, reagent and buffer cartridges, enzymes, formulations, QC assays) for the mid throughput market (NextSeq 500/550, NextSeq On a dally basis I interact with cross-functional teams, including manufacturing, development, product management, quality control, supply chain, R&D, and SMEs to evaluate risks for design and process changes impacting all sequencing consumables. Other responsibilities include- NPI transfer to on-market - On-market design changes to correct quality issues or improve product performance (CAPAs, QIs, OOS, nonconformances), qualification of alternate suppliers, manufacturing site transfers, QC assay updates-Design and product risk assessments -Design Verification planning -project management experience supporting the teams we work with coordinating timelines, resourcing and overall expectations for needed support with risk assessments, etc. experience with Jira software, Kanban and confluence interfaces-Design, draft and/or consult on experimental protocols. Oversee execution of verification studies (stability/accelerated shelf life testing). Redact/ review of engineering reports including data analysis-Management experience. Career development, 1:1 meetings, technical onboarding.