Elizabeth Hooten

206-***-****

acss6l@r.postjobfree.com

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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