Research Associate, Gene Therapy Upstream MFG

Laura Mendoza e: ***********@*****.***

Summary

I believe in the practice of good work ethics, effective communication and respect with others. I am detail-oriented in problem-solving, both independently and collaboratively. More importantly, I can complete projects on time. My experience from CLIA research and gene therapy manufacturing has been wonderful and I want to gain more experience. Currently I am seeking a job at a biotech company that provides continued interpersonal growth and the opportunity to continuously learn. Thank you for your time and consideration.

Education:

•M.S. Biology (Cell and Molecular Emphasis), San Francisco State University.

•B.S. Biology, (Cell and Molecular Emphasis), San Francisco State University.

•Pharmacy Technician Certification, Valley Medical Center, Fresno, CA.

Skill Set

Outlook/Microsoft proficient, aseptic technique, pipetting, sample preparation, tissue cutting and measurement, buffer preparation, mammalian cell culture, cell expansions of HEK293 and huh7, confocal microscope, cell counting, media preparation, RNA/gDNA isolation from tissue, serum, plasma, viral transduction, PCR gel electrophoresis, RT PCR and qPCR plate preparation, assay development using MSD and Luminex, buffer preparation, frozen cell pelleting, bioreactor setup and dismantle, GMP, GDP, SOP. Use of tube sealers, pumps, scales, Bio flex, BSC, incubators, harvesting, Integra liquid handler, Precellys Homogenizer, HFR plate reader, Nano drop and pH meter, able to manage data for analysis.

Work Experience:

DC3 Therapeutics Jan. 2023 to May 2024 Research Associate

•I attended training on/off site for projects as needed for instrumentation and safety.

•Learned new techniques for projects needed under supervision by scientists until independent.

•E. coli transformation, colony picking for Maxi Prep and gDNA isolation in ng/ul.

•Prepared media and buffers as required.

•PCR Techniques learned and utilized were end point, cDNA, fragment analysis, Mycoplasma diagnostics, gradient PCR. PCR applications were verified with gel electrophoresis and visual analysis. Performed Rapid Covid -19 tests as well. Set up sample plate in spread sheet, normalize and physically into plate for qPCR, cDNA, endpoint PCR analyses using appropriate controls.

•Aseptic technique was used to culture both adherent and suspension mammalian cell lines. This included monitoring confluence, conducting cell counts both auto cell counts and media changing for cell expansion when required. Also performed cell line authentication, banking and pelleting of cells for downstream histology staining applications.

•Gel extraction and purification of inserts/ vectors for cloning projects.

•Dose response assays in a team setting.

•Write protocols and revise them when necessary. Keep the notebook updated.

•Keep clients informed as their project progresses. Send post experiment data analysis and reports upon completion.

•Familiar with cell lysis, binding to matrix, washing and elution steps for Isolations.

•RNA and DNA Isolations from cell culture, heart, lung, muscle and brain tissue using kits and kingfisher platform for downstream applications.

•Familiar with MSD, Luminex and their maintenance.

•Executed primer design on different mycoplasma species for PCR Diagnostic project and assay transfer. These primers were designed with and without probes and quenchers.

•I understand stages of development small molecules> biologics> vaccines> oligonucleotides> cell/gene therapy production.

•Under the supervision, performed dose response assays for unknown compounds and reviewed data in the project’s timeline.

•Uploaded project data/ reports onto ASANA upon project completion. Create and print manifest for delivery.

•Performed primer design, vector /insert and prep for construct. Transformed into cell lines.

Result PPARA + GAL4 Luciferase expression vector in HEK293 cells.

•Maintain assigned instruments and ensured maintenance logs are kept up to date.

Astellas Gene Therapy Jan2022 – Dec 2022 Manufacturing Associate I

•Executed upstream production of HEK 293 cells for gene therapies.

•During a run, I assembled single use bioreactor bag for setting up of 200L and 500L Bio reactors with upstream team.

•Complete job training in specified time allotted. Lab equipment, safety, MFG fermenter bioreactor set up etc.

•Maintained upstream production monthly schedule.

•Ensure following SOPs as well as maintaining GDP by signing documents in batch records/ logbooks during GMP and Non GMP runs

•Using aseptic technique while conducting cell expansion with HEK-293 cell lines. From 1 ml cryotube to 500L bioreactor.

•Conducted transfection of large-scale cultures with 200L and 500L batches.

•Used Bio Flex for sample analysis routine during MFG runs.

•Involved in buffer preparation for production. Made volumes from 500ml to 50L bags using tube sealers and pumps.

•Maintained supplies for changing room, stock and clean room.

•Monthly and biweekly Equipment Cleanings.

•Completed weekly covid 19 testing.

•Used Oracle to systematically order from warehouse.

•Archive batch record documents from runs on company Google cloud files.

Baxter Healthcare May 2021 – Dec. 2021 Manufacturing Technician I

•Complete training on scheduled time line.

Support the manufacturing process and operate general production equipment in a clean room setting. Accurately place components into packaging units in a timely manner. Perform and maintain GDP and GMP guidelines while working in clean rooms.

•Prepare for packaging assembly in the clean room environment. Receive and distribute supplies into appropriate packages on the packaging / sealing machine

•Post manufacturing run I verified batch records, calculated batch production and logged information in appropriate places.

•Place Formulated Coseal cross link into syringes in clean room setting. Perform the cleaning of equipment small parts and clean room.

•Calculate batch and perform GDP on batch records upon production.

•Prepare and packaged products for shipment. Ensure products are labeled according to SOP and place them in shipment area.

Impossible Foods July 2019 – Sept. 2020

Data Integrity/Machine Operator, Impossible Foods

•Data entry included printing of work orders and filing completed work orders.

•Moved materials systematically using company software.

•Located missing lots and logged appropriately.

•Consolidated materials at end of production batches.

•Ensure data integrity by reviewing batch records.

•Operated OSC machine during production.

•Ran x-ray checks and film checks on packaging.

•Acquired and prepared samples for QA.

•Practiced GDP, GMP and LEAN thinking.

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