Thomas Cole Email & Phone Number

Framingham, Massachusetts, United States

Framingham, Massachusetts, United States

San Jose, California, United States

• Manage QC in terms of product quality, conformance to regulations and MBI policies and processes• Oversee all QC CAPA/CCR/Deviations/OOS• Oversee QC functions including sample management, testing of raw materials, intermediates, finished products and microbiology.• Develop QC staff through individual goals, recognizing and celebrating success and providing coaching• Support in writing and reviewing investigational, validation, and qualification reports.• Provide QC feedback as SME for CRB’s, MRB’s, internal and external audits.• Oversee trending and evaluation of QC Micro data• Generates or reviews qualification/validation plans and reports, CSV, equipment, processes, methods, and environment • Interface with clients to ensure QC compliance across all projects• SME Sterility assurance• Conducts data analysis and trending and monitors KPI’s• Support client calls and requests• Oversee implementation of new QC processes and process improvements including:o In-house Mycoplasma testingo In-house Sterility testingo Routine Gas Monitoringo Visual inspection programo Raw Material testing o In-house organism and microbial library establishmento QC Analytical data management and integrity

San Jose, California, United States

San Jose, California, United States

Senior Quality Control Specialist May 2018 to Present • Microbiology:o Subject Matter Expert in Environmental Monitoringo Designed, authored, implemented, and managed the environmental monitoring program to USP/ISO standards for a GMP clinical manufacturing facility. o Assisted in designing room qualifications for ISO 7 and ISO 8 cleanroomso Performed all safety assays including, endotoxin, mycoplasma, and sterility testing. o Assay development and qualification of Mycoplasma, Endotoxin, and sterility testing.• Cell Cultureo Mammalian cell culture of mature dendritic cells from CD14 selected cells. o Generated T-allo cells from irradiated mature dendritic cells.o Mammalian cell culture of control T-cell lines for flow cytometric analysis.• Analytical/Molecular:o Performed flow cytometric analysis for phenotype testing of CD19/CD22 Chimeric Antigen Receptor T-cells (CAR-T).o Performed flow cytometry to determine Anargy (potency) of modified T-allo Cells.o Performed Immunofluorescence chemistry assays for determining viral transduction efficiency in transduced keratinocytes and to determine viability of keratinocyte skin grafts.o Performed qPCR assays for detection of replication competent lentivirus.o Performed qPCR assays to determine the mean copy number of integrated proviral DNA. o Assisted in analytical development of digital drop PCR assay to determine homologous recombination.

Novato, Ca

Quality Control Analyst, Microbiology June 2016 to May 2018• Monitoring of HVAC, including sampling of surfaces, viable air, and total air particulates. • Sampling of RO/DI, AWFI, HWFI, pure steam, CDA’s and gasses for QC testing. • Responsible for analyzing in-process and environmental monitoring samples using Bioburden, KQCL, Nitrate, Visual/Odor, TOC and Conductivity testing methods.• Participated in method validation of bioburden and endotoxin assays.• Integral team member in the qualification of an entirely new facility, including qualification of HVAC, CDA/Gas, AWFI/HWFI, and pure steam systems.• Performed in-process testing for the validation of manufacturing processes.• Participated in studies to validate product fill monitoring.• Environmental monitoring of final product filling.• Qualified trainer for all EM assays.• Proficient in using MODA, with administrative rights including sample scheduling as well as updating and entering of equipment and media.• Proficient in using LIMS.• Performed growth promotion assay for the qualification of microbiological medias. • Responsible for deviation/excursion reporting using the Trackwise system. • Enumeration and characterization of microbial growth.• Trained manufacturing personnel in the use of MODA.• Responsible for laboratory upkeep, including stocking of lab materials, autoclave responsibilities, internal verification of pipettes, receipt and storage of media, operation and maintenance of hoods, and cleaning of laboratory equipment.

QC Cell Culture • All procedures and documentation performed in compliance with cGMP. • Aseptic culturing and maintenance of keratinocytes and fibroblasts for QC release of Production cell banks. • Responsible for intermediate and raw material release testing using growth promotion assays. • Responsible for operation and maintenance of the Orion 5 Star pH meter. • Responsible for general housekeeping, laboratory maintenance, preventative maintenance.• Assisted with the validation of several QC incubators and biological safety cabinets by setting up load configurations and dynamic test conditions.• Introductory training on operation and maintenance of FACS Canto II flow cytometer.• Trained to proficiency as a document editor on the Pilgrim documentation system.• Responsible for daily micropipette standardization. QC Microbiology • Qualified to work in sterile environments including classifications 100K, 10K, and 100. • Performed environmental monitoring in sterility suites using viable air samplers, particle counters, and RODAC plates.• Introductory training of Growth promotion assays for the quality control of microbiological medias. • Introductory training on endotoxin testing using Pyros Kinetix system Additional Responsibilities• Responsible for trending and data entry of multiple databases including environmental monitoring data, cell culture assay results, and final product rejections. Performed presentation of trending and raw data at monthly quality control meetings. • Deviation reporting• Performed mechanical testing (seal strength and package integrity testing) for final product packaging. • Performed detailed visual inspections of final product prior to packaging to ensure patient safety.• Responsible for shipping and receiving of biological medias and human neonatal foreskin.

Canton, Ma

• Obtained Good Manufacturing and Documentation (GMP) certification.• Proficient in GMP documentation. • Trained on Quality Control core documents, e.g. deviation reporting • Proficient in the use of micropipetting techniques.• Proficient on multiple OI QCP’s including equipment maintenance. • Proficient in thawing, seeding and harvesting cells.• Signed off to independently perform keratinocyte growth assay.• Responsible for entering data into EM trending spreadsheets.• Performed introductory trainings for VEGF quantification by Flow Cytometry and obtained a passing standard curve on first performed training