Adaptable and resourceful Manufacturing Specialist with 6+ years of experience in cell culture, biological manufacturing research experience. Committed to ensuring timely, efficient solutions to optimize therapies aimed at the treatment of cancer patients.
Overview
7
7
years of professional experience
Work History
Manufacturing Associate II
Immatics
10.2023 - Current
Aseptically generated autologous TCR T cells via lentiviral transduction
Performed routine/non-routine collections of aseptic biological samples from PBMCs and final drug product (Endotoxin, RCL, Myco, Sterility etc.)
Reviewed operational documentation (batch records, SOPs etc) and met with technical staff to address error traps, or material needs.
Co-lead deviation investigations (root cause analysis, Five Why, Fishbone etc) and wrote reports pertaining to consumables failure.
Aided in training of new personnel/collaborated with training staff regarding training optimization methods.
Carried out upkeep of LN2 inventory on-site and at off-site storage facility.
Coordinated pick-up/drop-off of patient material to LN2 storage
Aseptically formulated/coated AC bags and carried out aliquots of cytokines and CD4/8 microbeads
Manufacturing Associate
Alaunos Therapeutics
06.2022 - 08.2023
Aseptically generated TCR T cells utilizing electroporation and sleeping beauty technology.
Assisted with tech transfer regarding process optimization.
Optimized cell seeding density for culture initiation and maintenance.
Organized/presented at meetings with G-rex vendors (Scale-ready) to collaborate.
Optimized cell activation with Miltenyi T cell TransAct titration and affiliated potency assays.
Optimized conduit for improvement in cell electroporation - Miltenyi EP device vs Lonza.
Met with vendors that presented new equipment to the lab and gave briefing reports to supervisor.
Assisted in the development of the inventory system that encapsulated all of our consumables, equipment, as well as a tracker for calibration dates.
Research Technician II
Baylor College of Medicine and Texas Children’s Hospital
04.2018 - 06.2022
Development of novel T cell therapies to treat viral infections and cancers
Extensive tissue culture work to generate T cells targeting viruses (such as SARS-CoV2, cytomegalovirus, Epstein-Barr virus, adenovirus) and cancers (acute myeloid leukemia) from healthy donors and patients
Performed in vitro profiling of viral- or tumor-specific cells, including:
Immunophenotyping using flow cytometry to assess T cell subsets and memory markers
Intracellular staining, Luminex, ELISpot, and Fluorospot to evaluate cytokine secretion
Functional analysis using 51Cr-release cytotoxicity assay to assess for killing towards tumor cell lines
Identify HLA-restriction of antigens to determine applicable patient groups for the virus or tumor-specific T cells
Established pre-clinical data relating to safety and efficacy, to facilitate a phase I clinical trial (currently awaiting FDA approval for SARS-CoV2-directed T cells)
Acquired experience in in vivo mouse experiments, including injection of tumors/ T cells and evaluated response to treatment using bioluminescence imaging
Isolated and cloned antigen-specific T cell receptors (TCR) to develop genetically-engineered TCR-transduced T cells to treat tumors
Coordinated with principal investigators, post docs and peers for daily laboratory experiments, data interpretation and immune monitoring of patients with high risk hematological malignancies (Breast Cancer, Pancreatic Cancer) enrolled in Phase I/II clinical trials investigating the safety and efficacy of adoptive T cell therapy
Arranged patient blood sample procurements with research coordinators and clinicians at appropriate timepoints
Evaluated patients’ immune response using standard assays (Elispot, Luminex, Fluorospot)
Coordinated with pathology lab to obtain tumor samples to assess for clinico-pathological correlates
Maintained databases with individual patient profiles detailing laboratory findings and clinical status to allow correlative assessment of patient’s immune response to cancer and disease control
Longitudinal clinical and laboratory monitoring of COVID-19 patients and healthy donors
Collected and processed patient and healthy donor blood samples over time to detect and characterize endogenous T cells directed against SARS-Cov2
Correlated the above with the donors’ clinical status with the data obtained in a questionnaire on day of blood draw to investigate the importance of specific T cells for disease control
Quality Improvement initiatives:
Validated and optimized the Flurospot assay (Mabtech Iris), and established a new workflow to profile multiple cytokine secretion on a single cell level
Coordinated with lab manager for supply inventory and orders
Organized and catalogued research samples cryopreserved in liquid nitrogen tanks
Trained incoming students, post-doctoral associates and staff on various equipment and assay protocols (Mabtech Elispot reader, Flurospot, Luminex 200 multiplex) and various cell culture procedures (OKT3 blast generation, Dendritic cell generation, Transformation, Transduction, and Virus specific T Cell expansion)
2018 Center for Cell and Gene Therapy Summer Internship program coordinator
Education
Bachelor of Science - Biology
The University of Houston
Houston, TX
05.2016
Associates of Science - Biology
Lonestar College - Montgomery
Spring, TX
12.2011
Skills
6 years of experience in cell and gene therapy
GMP document revision/optimization
Data collection and Analysis
Proficient in operation of Sepax C-Pro, Miltenyi CliniMACS Prodigy and Plus, LOVO automated systems, Signata CT-5 Flexible fluid management system, NC200 and Revity Cellometer cell counter
2TCRT manufacturing (in up to an ISO Class 5 or Class A environment)
1 years in process development for optimizing transposition efficiency via electroporation, seeding density, and cell activation
Knowledgeable in technical transfer
Proficient in cell culture (small scale and large scale)
Honors and Awards
Research Technician of the Year, Center for Cell and Gene Therapy at Baylor College of Medicine, 2020
Publications
Leung WK, Torres Chavez AG*, French-Kim M*, Shafer P, Mamonkin M, Hill LC, Kuvalekar M, Velazquez Y, Watanabe A, Watanabe N, Hoyos V, Lulla P, Leen AM. Targeting IDH2R140Q and other neoantigens in acute myeloid leukemia. Blood. 2024 Apr 25;143(17):1726-1737. doi: 10.1182/blood.2023021979. PMID: 38241630; PMCID: PMC11103096. *co-second author
Hoyos V, Vasileiou S, Kuvalekar M, Watanabe A, Tzannou I, Velazquez Y, French-Kim M, Leung W, Lulla S, Robertson C, Foreman C, Wang T, Bulsara S, Lapteva N, Grilley B, Ellis M, Osborne CK, Coscio A, Nangia J, Heslop HE, Rooney CM, Vera JF, Lulla P, Rimawi M, Leen AM. Multi-antigen-targeted T-cell therapy to treat patients with relapsed/refractory breast cancer. Ther Adv Med Oncol. 2022 Jul 15;14:17588359221107113. doi: 10.1177/17588359221107113. PMID: 35860837; PMCID: PMC9290161.
Hoyos V, Vasileiou S, Kuvalekar M, Watanabe A, Tzannou I, Velazquez Y, French-Kim M, Leung W, Lulla S, Robertson C, Foreman C, Wang T, Bulsara S, Lapteva N, Grilley B, Ellis M, Osborne CK, Coscio A, Nangia J, Heslop HE, Rooney CM, Vera JF, Lulla P, Rimawi M, Leen AM. Multi-antigen-targeted T-cell therapy to treat patients with relapsed/refractory breast cancer. Ther Adv Med Oncol. 2022 Jul 15;14:17588359221107113. doi: 10.1177/17588359221107113. PMID: 35860837; PMCID: PMC9290161.
Lulla P, Hao Liu, Juan F. Vera, Rammurti Kamble, Carlos A. Ramos, French-Kim M,et al. The Safety and Clinical Effects of Administering a Multiantigen-targeted T cell Therapy to Patients with Multiple Myeloma. Science Translational Medicine. 2020; 12 (554):eaaz3339.PMID: 32727914
Martes-Martinez C, Méndez-Sepúlveda C, Millán-Molina J, French-Kim M, et al. Cost-utility Study of Warfarin Genotyping in the VACHS Affiliated Anticoagulation Clinic of PuertoRico. Puerto Rico Health Science Journal. 2017; 36(3):165-172. PMC: PMC5993426
Timeline
Manufacturing Associate II
Immatics
10.2023 - Current
Manufacturing Associate
Alaunos Therapeutics
06.2022 - 08.2023
Research Technician II
Baylor College of Medicine and Texas Children’s Hospital