• Direct and oversee Data Management, the Master Data LIMS team• Lead a cross functional matrix team in collaboration with IT and Data Business partners on creation of an internal data platform• Creation of Smartsheet Dashboards and Smartsheet’s to display KPI’s, project/program status and quality metrics across the Product & Analytical Organization• Train, develop, and mentor QC personnel and conduct performance evaluations to provide feedback on areas in need of improvement.

• Spearhead all daily activities related to incoming raw material specification creation/revision for release of samples and materials, as well as deviations and CAPA compliance tracking.• Direct and oversee Clinical Data Management, the Master Data LIMS team, and the Clinical Sample Management team.• Manages and develops direct reports including:-Management and scheduling of personnel within the department to meet manufacturing and laboratory schedules and needs.-Ensures employees are properly trained and qualified to perform their assigned tasks, providing performance evaluations, and supporting career development of direct reports.• Prioritize, coordinate, and execute multiple large-scale projects simultaneously.• Ensure legal obligations are followed and compliance with regulatory bodies and health and safety guidelines.• Gain an understanding of company needs, requirements, quality standards and communicate those to production teams for timely and effective clinical drug product release.

• Provided tactical leadership for the Clinical Sample Management team while presiding over incoming raw material specification document creation and release• Executed and trained personnel on Deviations and CAPA compliance tracking for the department• Developed and implemented effective process improvement initiatives in the areas of clinical binders, forms, and send outs for third-party testing.

• Manage all facets of deviations and CAPA compliance tracking, and process/continuous improvement activities through the implementation of the Smartsheet platform tracking key metrics such as out of specification, and validity rates, KPI's for training and quality records for the department

• Coordinated, executed, and analyzed QC molecular in-process, drug product routine release, stability testing, method validation and PPQ for the Phase 2/3 clinical study CAR T-cell product Abecma (bb2121).• Piloted ELISA method validation activities which were a major milestone for S12 commercial manufacturing.• Functioned effectively as the QC Lead working with cross-functional teams, including GPQ, SCM, ECQ, QA, QC on Breyanzi (JCAR017) technology transfer from JuMP, Seattle to S12, NJ• Headed the transfer of the IFNg AlphaLISA Method and associated cell culture assay component. • Coordinated the QC Molecular team across multiple sites (Warren and Summit) and managed change control projects.• Served on the Change Control Review Board Committee for the entire QC department at the Summit West S12 facility. • Provided SME services regarding various Molecular Methods, such as qPCR, ELISA, Appearance, and Cell Culture, for the QC team.

Development, method validation, and clinical sample testing using anti-drug antibody (ADA) assays to support immunogenicity assessments for pre-clinical and clinical studies of bio therapeutics in accordance with GLP guidelines.• Obtained strong knowledge and understanding of Watson LIMS.• Created and updated an electronic lab notebook and laboratory documentation.

• Achieved measurable success in the area of in vitro immunochemistry assay development on automated clinical analyzers using ELISA methodology through feasibility, development, and verification phases.• Coordinated and conducted extensive feasibility, verification, and validation studies for new assay development for the Thyroid Stimulating Immunoglobulin (TSI) biomarker.• Completed solid phase and reagent optimization using surfactants and preservatives in buffer formulations as well as analyzed resultant data to meet or exceed current assay specifications. • Carried out sample and reagent stability studies to assess product stability and assay performance.• Identified and assessed root causes in manufacturing for failure to meet assay design specifications using DOE methodology.

Biofunctional Assay testing in MnB Vaccine Research Program

Immunology testing using diagnostic kits on patient specimens for clinical results reporting