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Data Development

Location:
New York, NY
Salary:
Negotiable
Posted:
April 08, 2015

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Resume:

Elsie Grau

Preserve at Tobi Hill

*** ********* *****

Honey Brook, Pennsylvania 19344-1777

Cell Number: 610-***-****

Email: aco3ez@r.postjobfree.com

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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