Priscilla Wu Email & Phone Number

California, United States

Oversaw strategic initiatives and provided leadership in product care, ensuring global compliance, quality control, and innovation within the organization's product portfolio.• · Led cross-functional, cross-site teams to drive success and ensure optimization, enhancement and compliance of IVD products, including management of task lists and priorities, timelines, action items, budgets, meeting minutes and decision logs. Experienced in Quality, Regulatory, and Operations collaborations.• Collaborated with project managers across product lines on technical issues, project timelines and logistics, across multiple functional areas and countries in diverse and rapidly changing environments, to effectively handle up to 20 concurrent projects.• Investigator for 10+ root cause investigations into alleged product performance issues with solid problem-solving, experimental design and data analysis skills, resulting in product and process improvements and preserving customer trust.• Led a team of 6 scientists in post-launch development projects – assays, software and hardware upgrades, manufacturing processes and new consumable verification, bringing sustainability and new improvements to market in a timely manner and ensuring product manufacturing robustness and continuity.• Prepared investigation reports, external communication notices and presentations to facilitate internal and customer communication, increasing customer engagement and trust.• Managed project priorities and task lists for customer complaints, CAPAs, non-conformances, and OOSs to ensure timely resolution of highest criticality issues. Shepherded changes through the change control process.• Development Representative / SME in Post Launch Product Reviews. Responsible for Post Market Surveillance deliverables (PSURs, PMSRs). Provided support to external and internal audits (incl. FDA, international regulatory agencies, and customer audits).• Mentored scientists for their professional development

Drove the design and implementation of cutting-edge assay development strategies, leveraging scientific expertise to advance diagnostic technologies and support the company's mission of improving patient outcomes.• Led product feasibility and verification studies, transferred processes to Manufacturing, using skills of an assay dev professional which contributed to five successful product launches.• Represented Assay Dev and led discussions on technical and timeline alignment issues on PCR master mix optimization, PCR oligo transfer, reagent production, quality critical components, raw material availability, and production forecast. Aligned assay dev schedules with Operations project managers and representatives from different functional areas to ensure timely discussions and decisions to drive success.• Collaborated with multiple functional areas across multiple sites to drive the success of a mixed batch concept on the instrument platform by ensuring compatible strategy on testing plan, product requirements and risk assessment and analysis, resulting in better medical value in the product.• Spearheaded the design and execution of assay dev experiments, demonstrating exceptional analytical skills in data analysis and interpretation, culminating in insightful presentations and active participation in intra-departmental meetings to resolve technical and logistical challenges and propel projects forward.• Optimized reagent production and validation processes by defining specifications tailored to quality critical features, harmonizing with existing components to capitalize on stability and manufacturing expertise, thereby accelerating time to market and ensuring efficient product delivery.• Played a pivotal role in FDA submission processes, contributing to comprehensive responses and supporting regulatory compliance efforts, while actively participating in FDA meeting presentations to convey the scientific rigor and regulatory readiness of developed products.

• Led and performed critical assay development studies for master mix optimization, correlation to established methods, confirmatory testing on seropositive specimens, and stability with 500+ frozen specimens. Produced data to address FDA questions on product claims.• Transferred developed product to Operations. Established product testing protocols and validated product test methods. Represented assay development team for cross-site troubleshooting, knowledge transfer, and provided hands-on lab training. • Managed a team of 4 in Assay and Reagent Development for a blood screening project with PCR detection.

• Participated in formal validation activities leading to two new configuration launches of a blood screening system with automated sample preparation and real time PCR detection. Edited and executed test cases.• Evaluated system software functionalities and features. Investigated instrument workflow, software and database problems.• Organized customer technical support calls escalated to the Development team. Investigated customer issues. Documented correspondences among different teams regarding the investigations and technical discussions.