Lisset Pear Email & Phone Number

Clark, Nj, Us

Bridgewater, New Jersey, United States

Performed cell culture scale-up, cell culture evaluation and cryopreservation of multiple tumor cell lines and patient derived cells to provide high quality cell suspension in support of Xenograft studies. Provided feedback on technical challenges and their respective solutions and shared expertise & knowledge with the team.Provided adherent and suspension cells for cell-based assays as needed.Scheduled and coordinated deliveries of cells, evaluated timelines, project status, delays, and resources to ensure a reliable supply. Provided services and reagents in a flexible manner by keeping an open and honest communication with team while maintaining high levels of efficiency and productivity.Managed all SEC-MALS related activities. Conducted required upkeep maintenance, troubleshooting and instrument trainings. Interacted with vendors and purchasing department for obtaining and executing quotes and service contracts. Coordinated preventative maintenance services, upgrades for performance enhancement and repairs as needed for both instruments. Maintained laboratory records according to FDA guidelines. Authored SOP and technical reports. Presented scientific findings at departmental meetings. Delivered study summaries and project status reports to department leadership and executive management as needed.Collaborated with initiatives to reduced lab waste and streamline processes in support of decreasing operating costs and creating a leaner and more efficient lab operation.Skills: cell culture scale-up, cell bank generation, cryopreservation, thawing and recovery, project management, workflow design and optimization, resources management, inventory control and timelines evaluation, process report, protocol development, SOP authoring. data compilation, data analysis, database management, flexibility, adaptability, problem solving, collaboration and stakeholder management, training and mentoring

Bridgewater, New Jersey, United States

Produced high quality vectors for multiple serotypes including AAV8, AAV9, AAV2 AAVRh10 in support of preclinical efficacy and toxicology studies. Supported AAV QC process as needed. Lead evaluation studies for increasing AAV2 production yield. Evaluated Gibco AAV-Max Helper-free AAV production system using WAVE25 Bioreactor.Improved upstream bioprocessing efficiency for AAV production by evaluating new technologies for scale-up of adherent AAV293 cells.. Managed all SEC-MALS and WAVE25 bioreactor related activities. Conducted required upkeep maintenance, troubleshooting and trainings for both instruments. Interacted with vendors for obtaining and executing quotes and service contracts. Coordinated preventative maintenance services, upgrades for performance enhancement and repairs as needed for both instruments. Developed best practices for optimization and improvement of SEC-MALS methods for AAV samples, data analysis and reporting. Established additional QC criteria for AAV analysis. Reorganized operation’s workflow of SEC-MALS to increase number of operators, data analysis output, improve efficiency, and decrease operating errors.Supported CMC and Clinical development programs for vector optimization and characterization by SEC-MALS analysis. Authored SOP and technical reports. Presented scientific findings at departmental meetings. Skills: Gene Therapy, AAV production and QC including cell culture scale-up, transfection, AAV purification by iodixanol gradient, transduction, SEC-MALS, ELISA, SDS-PAGE, Western Blot, Mycoplasma and Endotoxin testing. project management, workflow design and optimization, resources planning, resources management, cost evaluation, inventory control and timelines evaluation, process report, protocol development, SOP authoring. data compilation, data analysis, database management. troubleshooting, critical thinking, collaboration and stakeholder management, training, mentoring and supervising

Bridgewater, New Jersey, United States

Produced multiple serotypes of high-quality vectors for in-vivo animal studies including AAV8, AAV9, AAV2 AAV5. Supported CMC and Clinical development programs for vector optimization and characterization by SEC-MALS analysis. Improved upstream bioprocessing efficiency from cryopreservation to scale-up by introducing the use of compact flasks to streamline the cell culture scale-up. Substituted volumetric split of cells with seeding by cell counts to increase process robustness. Introduced the use of companion flask as QC method for evaluating cells prior to transfection.Scaled-up 293F suspension culture for vector production in shaker flasks and WAVE25 bioreactor. Optimized transfection protocols and evaluated transgene expression using PEI to minimize costs. Managed all SEC-MALS and WAVE25 bioreactor related activities including method development for AAV samples, data analysis, reporting, and troubleshooting. Developed training materials and conducted in-house training for new users.Carried out the isolation, scale-up and cell banking of mouse MSC from compact bone and bone marrow. Developed a primary MSC-based transduction assay for AAV potency test.Maintained inventory of reagents and materials needed for AAV production. Negotiated price discounts with vendors for reagents and consumables used decreasing consumables costs by almost 30%..Skills: Gene Therapy, AAV production and QC including cell culture scale-up, transfection, AAV purification by iodixanol gradient, transduction, SEC-MALS, ELISA, SDS-PAGE, Western Blot, Mycoplasma and Endotoxin testing. project management, workflow design and optimization, resources planning, resources management, cost evaluation, inventory control and timelines evaluation, process report, protocol development, SOP authoring. data compilation, data analysis, database management. troubleshooting, critical thinking, collaboration and stakeholder management, training, mentoring and supervising

Hackensack, Nj

Performed and troubleshoot molecular diagnostic procedures which are instrumental to predict the prognosis of a diagnosed disease and guide therapy improving the lives of patients.Carried out GeneXpert RIF Assay for detection of MTB (Mycobacterium tuberculosis) complex from non-respiratory samples such as blood, stool and urine. Performed bacterial identification by PCR and Gene sequencing. Documented and reported results to Infection Control agencies.Performed STR/chimerism testing, FISH, PCR for detecting genetic disorders/gene arrangement with accurate correlation of results to patient diagnosis and clinical condition.Documented all quality control procedures performed. Prepared and updated documents and SOP's needed for CAP inspections by accreditation agencies.Skills: diagnostic molecular pathology, new test verification/validation, fluorescence in-situ hybridization, PCR for detecting genetic disorders/gene arrangement, STR/chimerism testing, bacterial DNA sequencing, QC, Infectious Diseases, Oncology, BL2 safety / Human Pathogen Handling, inventory control, process report, protocol development, SOP authoring. data compilation, data analysis, database management. and troubleshooting.

Janssen, Pharmaceutical Companies Of Johnson And Johnson

Developed methods to expand and differentiate human stem cells in bioreactors and spinner flasks in support of studies relating to an insulin-secreting, glucose responsive cell therapy for diabetes.Studied the acceptance range of process operating parameters and determine the critical parameters by continuously troubleshooting issues of quality and consistency during scale-up.Created tracking tables to evaluate GMP grade materials and protocols used which facilitated formulating strategies for meeting cell culture challenges and meeting GMP technical specifications. Maintained laboratory records according to FDA guidelines. Authored SOP and technical reports. Presented scientific findings at departmental and team meetings. Skills: Cell Therapy, human embryonic stem cells, cell culture maintenance and scale-up, suspension cell culture, cryopreservation, thawing and recovery, inventory control, process report, protocol development, SOP authoring. data compilation, data analysis, database management. and troubleshooting

Rahway, Nj

Addressed the increasing needs of cells as reagents to support lead optimization and lead identification. Ensured appropriate reagent characterization and establishment of quality control procedures to provide reliable quality cells and membrane stocks; responsible for a total of 50 cell lines. Developed protocols to outsource reagent generation; transferred 5 cell lines within 4 months to contract research organizations (CRO) to support 3 High Throughput Screening (HTS) campaigns. Ensured execution on time, on budget and on quality.Created banks of assay ready frozen cells to support 1-2 years of primary assay for 3 programs and 14 cell lines. Increased assay flexibility (could be run at multiple times) by evaluating seeding conditions of frozen cells used.Developed protocols to optimize growth culture and banking conditions for primary cultures of rat hepatocyte to support weekly assay and contributed to generation of more meaningful in vitro data.Automated cell culture tasks by use of SelecT from The Automation Partnership (TAP). Provided weekly maintenance of robotic cell culture unit and ensured system meets safety requirements, proper calibration and functionality.Reduced the turnaround time of generation clonal cell lines from 4-6 months to 8 weeks for 8 cell lines by using Invitrogen’s Target Integration Technology.Skills: cell culture scale-up, manual and automated cell culture, SelecT, Incucyte Live-Cell Analysis System, maintenance of primary cell cultures, cell bank generation, cryopreservation, thawing and recovery, project management, workflow design and optimization, resources management, inventory control and timelines evaluation, process report, protocol development, SOP authoring. data compilation, data analysis, database management, flexibility, adaptability, problem solving, collaboration and stakeholder management, training and mentoring.

Rahway, Nj

Managed, developed, and performed High Throughput Screening (HTS) on various GPCR targets through Fluorescence Imaging Plate Reader (FLIPR) and cAMP assays (LANCE, CisBio and HitHunter assay technologies) screening for agonist, antagonists and allosteric modulators. Evaluated selectivity of potential hits on cells transfected with receptor of interest versus parental cell line.Evaluated project timelines, provided feedback in terms of feasibility and interfaced with all operations to ensure end-to-end delivery.Operated various automated liquid handling systems (Biomek FX, and 2000, multidrop) and multi-mode readers (ViewLux and Envision Alpha). Processed and analyzed HTS data.Skills: GPCR receptors, HTS, compound library handling. Alpha Screen, FRET, LANCE, Flashplate, HTRF, CellKey, label-free electroluminescence technologies, Spectraax, Envision readers, TECAN EVO, BIOMEK 2000, BIOMEK FX, and liquid handlers/dispensers, SOP authoring. data compilation, data analysis, database management, lab management/lab automation, problem-solving, analytical, organizational skills.

Rahway, Nj

Worked as a critical member of a team to design, validate and implement a core robotic cell culture facility at Rahway site: using SelecT from The Automation Partnership (TAP). Generated a memo outlining the capabilities and limitations of the system utilizing cell data results, customer feedback, operator’s input and department surveys. Demonstrated a clear impact of use of automation on 10 programs based on 3 types of activities: preparation of membranes, production of cells for rapid development/optimization and production of flasks and plates for routine screens. Provided and designed training for backup personnel that increased customer response rate by 25%.Maintained high level of client satisfaction with all interactions and deliverables.OTHER CONTRIBUTIONSGenerated a NSE-mouse construct for generation of Tx mice in support of Receptor Occupancy studies for a CNS GPCR receptor.Evaluated MAPK activation transduction pathways in cell lines expressing receptors of interest through SDS-PAGE and western blot.Implemented a phospholipidosis assay for evaluation of medicinal chemistry compounds.Skills: GPCR receptors, manual and automated cell culture, SelecT cell bank generation, cryopreservation, thawing and recovery, assay development, protein characterization and immunological analysis, DNA/RNA isolation and purification, DNA gel electrophoresis, project management, workflow design and optimization, resources management, inventory control and timelines evaluation, process report, protocol development, SOP authoring. data compilation, data analysis, database management, flexibility, adaptability, problem solving, collaboration and stakeholder management, training and mentoring.

Rahway, Nj

Generated and evaluated hybridomas for monoclonal antibody production for N. meningitidis mimetic vaccine program. Screened hybridomas to select highly productive and stable clones with ELISA. Performed additional assays to measure cell growth, cell specific productivity and titerAdapted highly productive and stable clones to grow in serum free media.Maximized productivity of hybridoma lines up to 50-fold by use of CELLine Membrane Technology from Becton Dickinson.Implemented protocol for production and purification of reagent quantities of IgM subunits for lead optimization. Carried out panning of selected subunits to identify mimetic peptides using 3 libraries. Evaluated phage candidates using competition ELISA to identify amino-acid sequences that mimic epitope of interest.Trained other team members on cell culture techniques.Skills: mammalian cell culture, generation and cloning of hybridomas, cell line adaptation to suspension and serum-free formulations, IgG and monomeric forms of IgM purification and characterization. (NH)2SO4/PEG precipitation, dialysis, gel filtration and affinity chromatography. SDS-PAGE, IP/Western Blot, ELISA and Phage Display Technology. Cell preparation for sorting, assay development, data analysis and reporting, mentoring and training.

Merck And Co., Inc, Mrl Atheroesclerosis And Endocrinology

Characterized tissue distribution of hormonal nuclear receptors on surgical specimens from National Development and Research Institute. Conducted functional analysis of these receptors by IP/Western blot.Carried out purification and characterization of polyclonal antibodies.Isolated RNA from tissues from treated animals with compound of interest, cDNA synthesis and analysis of RNA by Northern Blot and Real-time RT PCR (TaqMan Assay).

B.S., Biochemistry

Certification In:, Clinical Research, Clinical Data Entry And Oracle Clinical

Basic knowledge IND, NDA, GCP/ICH guidelines, FDA regulations, internal policies and SOPs for conducting clinical trials developed.