Maintenance Quality
Resume:
Elizabeth Hooten
****.******@*****.***
Summary
Experienced science professional with experience ranging from research and development to biopharmaceutical testing. Experience with molecular biology, microbiology, cellular biology as well as virology and electrophysiology. Worked extensively with gene expression in mammalian cell culture as well as viral knock-down due to biochemical compounds. Experience in technical writing and statistical data compilation as well as adhering to the strict procedures and guidelines as set forth under the cGMPs and ICH. Worked with higher level viruses in a BSL-3 environment. Other experience also includes propagation of viral stocks and mammalian cell culture as well as the usage of laboratory equipment such as liquid handlers and robotics. Also trained in electrophysiology procedures such as conventional and automated patch clamp. Experienced in assay development and cell based assays.
Career History
Theraclone/Nuwest LabTemps, Screening Jul 2015 – Dec 2015
Research Associate
Contractor at Theraclone
Extensive cell culture, 25-30 cell lines at a time both immortalized and primary cells
Cell prep for FACs assays (bulking up lines, staining cells for detection)
Member of Ebola project team – assay development of primary screen ELISA
IgG ELISA for various projects
Assisted with Protein A purification, cross-linking experiments for process science group
Use of automation – VAL (robotic arms), Platemate, ELx plate washers, Janus, Multidrop
Amgen/Lancaster Laboratories, Bioassay and Biofunctional Characterization Oct 2012 – Dec 2014
Senior Scientist
Serve PSS client on site at location in Seattle - Contractor at Amgen in P&PD
Extensive cell culture experience using various BSL-1 and BSL-2 mammalian cell lines for use in cell based assays
Perform CDC and ligand binding assays for routine sample testing as well as for assay development
Perform ADCC assays for various projects
Participate in development of assays that will be transferred to the QC department
Assay qualification including linearity, robustness, specificity
Participate in the cleaning and maintenance of laboratory equipment as dictated by GLP
Use of various software such as Softmax and SAS for data analysis as well as Maximo for laboratory maintenance
Use of electronic notebooks for record keeping
Dendreon, Inc., In Vitro Biology/Biochemistry, Seattle,WA Apr 2010 – Sept 2012
QC Associate II
Maintain high quality standards as dictated by cGMP and USP regulation
Perform commercial and clinical testing using both in vitro biology and microbiological skill sets
Perform in vitro assays such as mIL-2 ELISA, TF-1 based stability assays, TCID50, sipuleucel-T antigen presentation, AIM-V cell proliferation
Support testing and investigations for all IMFs
Performed weekly monitoring of water system
Performed weekly environmental monitoring of clean rooms used for clinical manufacturing
Perform microbiology assays such as growth promotion, gram stain, turbidimetric endotoxin detection, kinetic chromogenic endotoxin detection, sterility using BacT, enzymatic mycoplasma detection, bioburden, TOC, conductivity, visual inspection of raw materials
Mammalian and insect cell culture using sterile and aseptic techiniques
SOP generation and maintenance as well as technical report writing
Cell banking
Biochemistry assays such as AEX HPLC, densitometry, osmolality, pH, NuPage
Use of Waters HPLC with Empower Software
Assist in the development of new assays for the QC Operations group
Maintain equipment by assisting with validations, calibrations, and preventative maintenance
Spreadsheet validation
Cerep, Inc., Electrophysiology/Toxicology, Redmond,WA Feb 2007 – Dec 2009
Research Associate II
Performed manual and automated patch clamp for client studies
Assay development and validation for testing drug candidates on various voltage and ligand gated ion channels
Creation of stable cell lines through lipid based transfection for use in ion channel assays
Tissue Culture Coordinator – maintaining the tissue culture lab facility, writing of quality documents and procedures for tissue culture, ensuring facility runs smoothly, training of analysts in aseptic techniques and proper cell propagation procedures
Performed mammalian cell culture
Performed HTS for the mGluR8 assay
Developed mycoplasma testing program guidelines as well as performed enzymatic mycoplasma screening assay
Assistant lab manager – ordering, receiving, dealing with general lab issues
Wrote and maintained SOPs to maintain quality
Performed temperature monitoring for GLP equipment
Performed equipment maintenance for laboratory equipment such as incubators, freezers, centrifuges
Deal with outside vendors and service technicians for calibration of pipettes, microscopes, incubators, biological safety cabinets, and automated patch clamp robot
Prepared media and buffers
Data analysis
Use of the JANUS and TECAN liquid handler
MDS Pharma Services, Virology, Bothell, WA Jul 2004-Aug 2006
Associate Scientist II
Facilitated client’s progress with drug manufacturing by carrying out viral clearance studies and analytical tests on samples provided by clients
Assisted in assay transfer and development
Performed sterile and aseptic techniques in BSL-2 and BSL-3 environments that maintained cGMP/GLP regulations for quality assurance
Wrote and maintained SOPs to maintain quality
Trained to perform equipment mapping
Compiled data for studies as well as assembled reports and studies for release to clients and QA
Performed microbial assays such as reconstitution, non-host detection, plasmid retention analysis, gram stain, microbial identification and other biochemical tests
Performed assays such as LAL endotoxin detection, isoenzyme analysis, IFA staining, adventitious virus detection, TCID50, plaque, cytotox/interference, ELISA, mycoplasma detection per the PTC method
• Preparation of various viral stocks from infection of mammalian host cell to harvest, purification, and validation
of titer; plaque reduction assays to determine titer of virus present; growth curves for propagation; TCID50
determination
Performed mammalian cell culture with and without antibiotics for use in studies
Mirus Bio, Product Development, Madison, WI Jan 2003-May 2004
Assistant Scientist
Performed testing of proprietary formulations and developed strategies for the delivery of DNA, siRNA, mRNA, etc. through transient transfection in vitro
Developed protocols for use in the quality control of products as well as by technical services for assisting customers
Performed mammalian and insect cell culture using aseptic technique as well as created stable mammalian cell lines for knock-down and expression studies
Isolated primary cells from tissue for use in assays
Used various methods of analysis such as western blot, luciferase, Beta-gal, LDH, SEAP, Invader, total protein, Bradford, and live/dead.
Used techniques such as mRNA synthesis, RNA isolation, creation of expression plasmids, digests, electrophoresis, high throughput screening
Education
Bachelors of Science, Biology East Texas Baptist University 1997- 2002
References
Available upon request
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