Senior Vice President of Operations

• Mar 2023 - Present

Vice President, Global Laboratory Operations, Pharma Services

• Jan 2022 - Jan 2023

Senior Director of Project Management Operations

• Nov 2020 - Jan 2022

Director of Project Management Operations, Pharma Services

• Nov 2019 - Nov 2020

Director of Project Management, Pharma Services

• Aug 2018 - Nov 2019

Manager, Business Services and Clinical Operations

• Apr 2017 - Aug 2018

Senior Project Manager

• Dec 2015 - Oct 2016

- Manage clinical trials and projects of various testing modalities (including Immunohistochemistry, FISH, PCR, and Flow Cytometry). Plan, implement and track deliverables and timelines. Manage studies from set-up to database lock and reconciliation of final data. - Coordinate with sponsors, laboratory operations, and third party CROs to address issues and develop resolution-based outcomes. Proactively manage and anticipate risks for successful project delivery, and escalate issues in accordance with company policy. - Collaborate with Quality Assurance and participate in audits, inspections, and other quality initiatives. - Monitor study progression by continual communication with project team members and review of documentation and data. - Author, implement and maintain SOPs and review procedures to ensure compliance. - Manage study budget and perform invoicing throughout the life cycle of the study. - Prepare Data Transfer Specifications and work with project support on file formatting and data transmission. - Evaluate current processes to find opportunities for simplification and efficiency. - Work closely with Business Development team to prepare and review RFIs, RFPs, contracts and budgets; create amendments to SOWs as needed. - Serve as senior member of project management team, and lead and mentor junior staff on their professional growth. Show less

BioPharm Project Manager (Clarient)

• Sep 2014 - Dec 2015

Principal Project Manager, Clinical Trials

• Jan 2008 - Aug 2014

- Manage clinical trials involving various test platforms (Immunoassays, Bioassays, Flow Cytometry, IHC, FISH, Cytogenetics, Molecular Tests). Serve as designated liaison with the clinical sites and clinical monitors. Implement and coordinate all associated sample testing activities and data reduction/reporting. Draft contracts, work orders and amendments. - Develop, implement and oversee projects for the development/optimization and validation of commercial and novel assays used for clinical testing applications. - Study Director for Immunoassay, Bioassay, FISH and Immunohistochemistry projects; oversee and review validation area processes and perform laboratory functions (development, optimization, troubleshooting) as needed. - Develop validation plans, validation reports and SOPs required for implementation of validated methodologies. Prepare reports, make recommendations and present findings to management and pharmaceutical/biotech clients. - Direct and train lab technicians on optimization/validation/qualification procedures for multiplexed methods (SearchLight, Luminex and Meso Scale Discovery Sector Imager) - Comply with FDA, GCP ICH, CLIA and CAP regulations as they relate to clinical trial documentation and procedures - Scientific lead on Companion Diagnostic projects; attend pre-submission meetings with FDA and provide input on validation strategies for protein biomarker immunoassays and CDx tests. - LabCorp Laboratorian of the Year Award, 2014 Show less

Validation Coordinator

• 2005 - 2008

- Developed and managed validation projects to establish suitability of commercial and in-house assays for clinical testing applications via various multiplexing technologies (Pierce SearchLight, Luminex, Meso Scale Discovery, Cytomics FC500) and single-target platforms (Tecan, Immulite, Hitachi) - Served as lead technical writer responsible for developing validation plans and validation reports, as well as bio-analytical protocol and end-of-study reports - Directed and trained lab technicians on optimization/validation/qualification procedures for multiplexed methods; implemented and coordinated all associated sample testing activities and data reduction/reporting - Performed laboratory functions (development/optimization/troubleshooting) as needed - Prepared reports, made recommendations and presented findings to management and pharmaceutical/biotech clients - Created standard operating procedures (SOPs) and analytical procedures required for implementation of validated methodologies - Participated in cross-functional teams (Lab/Project Management/QA) to devise and implement validation strategies in support of clinical trials from all phases of development; interacted with subject-matter experts to ensure alignment with the goals, strategies and objectives of a project; collaborated with Project Management for final documentation release - Collaborated with laboratory and QA personnel to ensure proper documentation and complete audit trails of laboratory activities involving GLP studies (assay worksheets/deviation memos) - Performed method validation and clinical sample analyses according to industry and regulatory standards (CLIA, CAP, NCCLS, FDA, GLP, GCP, 21 CFR Part 11) - Collaborated with Scientific Director in scheduling, organizing and managing validation activities and clinical studies throughout the laboratory and among all affected departments and personnel - Trained technicians on general and assay-related laboratory procedures Show less

Senior Associate

• 2001 - 2005

- Developed, validated and automated functional cell-based assays (cytokine release, cell proliferation) for the quantitative/qualitative detection of drug-specific neutralizing antibodies present in biological samples - Developed novel drug depletion method to enhance assay sensitivity and overcome drug product interference (via removal of residual drug present in a sample using biotinylated antibody/drug with streptavidin beads) - Propagated and generated stable cell lines for in vitro studies; performed routine maintenance of adherent and suspension cells (human/monkey/murine); responsible for preparation and qualification of master & working cell banks - Automated bioassay and immunoassay procedures on robotic instruments systems (Tecan Genesis Workstation, Vi-CELL Cell Viability Analyzer) and validated liquid handling systems under GLP/21 CFR Part 11 compliance (IQ/OQ/PQ); Recognized for achievements in automation, Jan. 05; first to fully automate and validate an R&D Systems ELISA on a 21 CFR Part 11 compliant robot (Tecan Genesis) - Created and implemented reference documents (analytical procedures, standard operating procedures, validation plans, validation reports, end-of-study reports) - Assisted in supervision of CROs to facilitate method transfer and validation; trained scientists on procedures, ensured procurement of reagents/materials & relevant documents; performed troubleshooting experiments; reviewed validation data - Provide training to analysts/technicians on assay procedures and lab instrument/equipment operation/maintenance - Collected, interpreted and prepared scientific data for presentation; provided critical levels bioassay data to the Data Review Board (DRB) for a high profile project in Inflammation Show less

Research Associate III

• 1999 - 2001

- Developed and validated ELISA-based Lambda Antigen Trays (LAT) in the Terasaki tray format for histocompatibility (HLA) testing, IgG antibody determination and identification of specific HLA Class I and Class II antibodies - Enhanced LAT product resolution by developing a higher definition/specificity tray coated with a single antigen per well (Single Antigen LAT) - Prepared affinity columns and performed antibody/antigen purification, labeling and characterization - Conducted QC testing and stability studies on various products for determination of optimal storage/handling and shelf-life - Maintained proper documentation of laboratory experiments and conducted daily lab functions in accordance with ISO 9001 regulations - Trained new staff on lab protocols and general lab maintenance - Collected experimental data for analysis, interpretation and presentation Show less

Research Assistant

• 1996 - 1998

- Supported post-doctoral staff with in vivo and in vitro studies to develop novel genetic immunotherapies for combating human hepatocellular carcinoma (HCC) - Propagated murine in vivo tumor models (SCID) and administered various treatment strategies (via s.c./i.m./i.p. injection) with direction from senior staff - Routinely monitored, recorded and reported tumor incidence and growth on mice models; handled animal models in accordance with the UCLA Animal Care Policy - In vitro cultured dendritic cells harvested from murine bone marrow; maintained multiple murine and human HCC cell lines (EL4, Hepa 1-6, Hep3B, HepG2) - Performed ELISAs, DNA plasmid preparation, restriction enzyme digest, gel electrophoresis, Western Blots, protein purification and characterization - Responsible for general lab maintenance and supply inventory Show less