Data Development
Resume:
Elsie Grau
Preserve at Tobi Hill
Honey Brook, Pennsylvania 19344-1777
Cell Number: 610-***-****
Email: *********.**@*****.***
EDUCATION: West Chester University Department of Chemistry (Toxicology)
West Chester, PA
Major: Toxicology Internship
Graduate at the Inter American University, Rio Piedras, PR, USA
Degree: Bachelor of Science
SUMMARY:
25 + years industry of experience conducting studies under GLP and GMP
environment
Experience in method validation, assay development and sample analysis
Experience with both small and large molecule
Experience HPLC, UHPLC, Spectrometers, Elisa, Titrations, Immunoassay,
LC/MS-MS
Experience trouble shooting instrumentation and equipment
Experience interpreting and analyzing scientific data
A team player with effective communication/ listening skills
Fully bilingual with competency in speaking and writing English and Spanish
Excellent organization skills and able to manage multiple task
simultaneously (fast pace environment)
EXPERIENCE:
Glaxo Smith Klein: Dept. Analytical - Bench Scientist II: 709 Swedeland
Road,
King of Prussia, Pa. 19406 From 8 September 2014 to 13-March-2015
Performing analytical testing to support or release starting materials
Operate laboratory equipment (but with regard for GMP and Safety)
Execute experiments based on established protocols and implement
improvement
Work to GMP standard as appropriate
Demonstrated competence in using computers for data processing and
reporting lab results
Generating data using Empower software
eE- electronic entry of data
Chiral chromatography
Karl Fishers and Chloride -Titrations
Testing for Drug Related products and compliant with all laboratory safety
training
Teva Pharmaceuticals. Dept. DMPK - Research Associate IV: 145 Brandywine
Pkwy,
West Chester, Pa. From 14 October 2011 to 16 July 2013
Develop and validate methods for sample analysis using UHPLC, HPLC
(Fluorescence and UV/VIS)
Design and conduct assay optimization experiments and analyze experimental
results
Analyze data and evaluate analytical data results
Trouble shoot instrumentation
Handeling biological and stability samples
Design and conduct assay optimization experiments and analyze experimental
results
Trouble shoot assay problems
Write lab reports and presenting data to team
Attention to details and interpretation of scientific data
Independently run experiments to develop assay in different matrixes
Perform testing in stability samples
Design and execute studies to assess reagents, stability and validation
Perform quantitative analysis of bio-fluids for compounds
Analysis of samples using LC/MS-MS Schimatzu API 4000
Log In samples into LIMS system, Watson, Totalchrom and Analyst 4.1.1
Conduct, coordinate and supervise departmental internal audit
Cephalon (merge) Teva Pharm. Dept. Drug Safety and Disposition - Research
Associate IV: 145 Brandywine Pkwy, West Chester, Pa. From December 2003 to
14 October 2011
Develop, validate methods, sample analysis using HPLC (Fluorescence and
UV/VIS)
Analyze and evaluate data results
Prepare stability, validation results, study reports, summarize and
tabulate results
Conduct, coordinate and supervise departmental internal audit
Research for UHPLC method development
Cephalon, Inc., Dept. Drug Safety and Disposition - Research Associate III:
145 Brandywine Pkwy, West Chester, Pa. From December 1999 to December 2003
Develop, validate methods for analysis using HPLC (Fluorescence and UV/VIS)
Conduct sample analysis and data summary
Supervise part-time employees
Conduct and supervise departmental internal, contract audits and audit
coordinator
Analyze and evaluate analytical data results
Solid and liquid phase extractions
Inventory, track records and login samples and developing, generate master
spreadsheets
Cephalon, Inc., Dept. Drug Safety and Disposition - Research Associate II:
145 Brandywine Pkwy, West Chester, Pa. From August 1995 to December 1999
Conduct validation using ELISA, IGFBPI, IGFBPII, IGFBPIII in
Radioimmunoassay (RIA and IRMA) HPLC analysis on monkeys, dog, rabbit,
monkey, human (both serum and plasma)
Handling of radioactive materials isotope I-125
Solid phase extraction (SPE)
Wet chemistry
Assay development for experimental drugs using HPLC
Screening of blank plasma or serum for study and analysis of study
. Conduct validation of Elisa, IGFBP-I, IGFBP-II, IGFBP-III, (RIA and
IRMA)
. Solid phase extraction using C-18 columns, radioimmunoassay kit
preparation (Isotope I125), gamma counter, data acquisition and
evaluation, record keeping, sample inventory and auditing procedure in
accordance to GLP
Cephalon, Inc., Dept. Drug Development - Chemist: 145 Brandywine Pkwy, West
Chester, Pa. From April 1993 to July 1994
Wet chemistry
Long and short term stability analysis on compound tablets under GMP and
GLP
Perform dissolution on apparatus I and apparatus II
Analysis on stability tablets and physical testing using HPLC
. Assay development for experimental drugs and their metabolites using
HPLC analysis and spectrophotometric techniques
. Stability assay and testing on tablets
. Determining and reporting drug development
. Dissolution of drug tablets for long-term and short-term stability
Johnson and Johnson/Merck. Dept. Stability - Research and Development
Fort Washington, Pa. From April 1992 to January 1993
. Raw materials, sample testing using different techniques: HPLC, GC,
UV, Spectrometry
. Stability analysis on bulk powder and suspensions
. Validations on clinical methods and specs to approve raw material
Mc'Neil Pharmaceutical. Dept. Analytical - Research and Development
Fort Washington, Pa. From October 1991 to April 1992
. Analytical test on raw materials such as gel-caps, powders, liquids,
tablets
. Analysis on infra-red on FTIR files, UV, spectrophotometers
. Compiling raw data on software
. Raw data was submitted on software package such as higgins and peak
pro
Wyeth/Ayerst. Dept. Quality Assurance: West Chester, Pa. From May 1991 to
October 1991
. Particulate matter analysis and samples on drugs according to written
and/ or specific standard operating procedures using gas
chromatography, physical and analytical testing
. Analytical testing on samples; penicillin, morphine and in process
filled containers, sample bottles
Pennsylvania Race Horse Testing Laboratory. Dept. Agriculture,
West Chester, Pa. From September 1990 to May 1991
. Chemical and physical testing of drugs (morphine, cocaine,
amphetamines) and other drugs present in race horse and jockeys
. Analysis in blood, urine and biological fluids
. Testing procedures include preparing extractions, buffers, solutions,
different sprays reagents used for thin layer chromatography
. Analysis of plates, pH meters, organic extractions, preparation
different drug standard
. Analysis using ELISA, PFIA, gas chromatography, mass spectrometry
. Complete assigned projects on individual or group basis analysis by
immunoassay techniques
. Compiling raw data on software
5 Prime-3 Prime Inc. 145 Brandywine Parkway, West Chester, Pa. From Jan
1985 to Sept 1990
. Cloning, mono-cloning, DNA (salmon sperm In-vitro)
. Purification of nuclei acid using organic extraction
. Manufacturing of radioimmunoassay (RIA) and (CAT) kits under GLP and
GMP guidelines
CERTIFICATION:
. cGMP and cGLP certified
. LC/MS-MS Micromass Quarto
COMPUTER SKILLS:
Excel, MS Word, Turbochrom, Totalchrom, Watson, Analyst, Tom-Tec, Watson
LIMS,
Compliance Wire (Endugenesis), Empower, Electronic Entry (eE notebook)
INSTRUMENTS:
Perkin Elmer Series 200 UV/VIS Detector, Perkin Elmer Series 200 Auto
Sampler, Perkin Elmer Series 200 LC Pump, Jones Chromatography Column
Heater 7990, and Jasco FP-2020 plus Fluorescence Detector, PE Nelson 600
Link and 900 Interface, Advance LC Sample Processor ISS200, using
Turbochrom, TotalChrom and Watson LIMS Software Data Collection Systems,
Schimatzu Scientific Instrument, TomTec (Quattra 4), Agilent 1100 series,
Hewlett Packard 1100 series, Labconco Digital Chloride Meter, Cole Parmer
Chloride Analyser # 926, Agilent 1100 and Agilent 1160 both series, CTC
Analytics from Lep Technologies Combi PAL
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