Sr. Director, R&D

• 2023 - Present

Sr. Director, R&D

• 2021 - 2022

Job Responsibilities: I exhibit my extraordinary expertise in leading and supporting departmental initiatives, including new IVD product development in transplant and oncology assays. I ensure the development and validation of assay in efforts to utilize next-generation sequencing, ddPCR, and RT-PCR to support IVDD and IVDR submissions. I efficiently manage the molecular genomic technical team. Key Achievements: • Advised and effectively guided the creation of a quality management system to support IVD submissions in US and EU. • Developed and implemented robust strategies for IVD development in NGS, PCR, and digital PCR platforms. • Provided effective technical guidance for MoIDx and regulatory submissions for the new products. Show less

Sr. Director, Pharma Services

• 2020 - 2021

Job Responsibilities: During this job role, I delivered exceptional services in spearheading and efficiently managing the tech transfer, scale-up projects, and assay development, including qualification, transfer, and validation. I monitored and supported departmental initiatives, such as new technology development and continuous improvement projects. I ensured for development and assay validation in efforts to utilize Next Generation Sequencing, ddPCR, and RT-PCR to support pharma service testing. Key Achievements: • Established and won several millions of dollars contracts with pharma companies by leading and efficiently managing the technical teams. • Successfully provided and implemented a robust GxP compliance strategy for operations, quality, and product development teams. • Created effective SOP, validated plan and report, work instructions, or policies related to the pharma services. • Counseled and guided products and laboratory production teams regarding regulatory submissions. Show less

Sr. Director, Clinical Oncology R&D

• 2016 - 2020

During this job role, I conducted audits and quality control verifications of key clinical and regulatory documents. I ensured the establishment of the pathology/oncology laboratory for CLIA & CAP licensures. I supervised tech transfer, scale-up projects, and assay development, such as qualification, transfer, and validation. I ensured the development of GxP training and compliance. Key Achievements: • Leveraged expertise in developing and maintaining the audit strategies and programs for the quality management system (QMS) in the laboratory as per the related management functions. • Successfully enabled the sales of HLI's oncology business to Neogenomics by developing and validating the entire Exome Sequence assay. Show less

Associate Director, Molecular Biology

• 2012 - 2016

Job Responsibilities: I directed regulatory compliance efforts to support clinical and pharma laboratory testing. I ensured assay development efforts utilizing Next Generation Sequencing to support clinical and pharma service testing. Key Achievements: • Successfully catalyzed the Next Generation Sequencing test success rate, improved accuracy, and reduced turn-around time by executing testing workflow process improvements. • Served as a technical leader for new product development core teams, including applications to support liquid biopsy and Immuno-oncology RNA-seq panel programs. • Facilitated technology adoption efforts in the US and Asia by creating effective training programs/procedures while providing training to ex-US countries. • Contributed to the approval of the organization's first NGS assay by the FDA by developing validation strategies for NGS assays. Additional Experience: Director, Product Development/Carisomes Production Laboratory | Caris Life Sciences, Inc Vice President, Regulatory Affairs and Operations | Response Genetics, Inc. Director of Regulatory Affairs/Quality Assurance | Response Genetics, Inc Head of Operations, USA | Response Genetics, Inc Show less