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WHAT
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Scientist
Job
PPD
US
-
Hamilton,
New Jersey
Job Code - 19920
Position -
Job First Active on: Thursday, November 05, 2009
APPLY TO THIS JOB (You will be applying directly to PPD for this position!)
JOB DESCRIPTION: Scientist
Description
This position is based in Hopewell, NJ.
The Scientist will require a B.S. or B.A. in chemistry, biochemistry or biology with 2 to 4 years experience in biopharmaceutical analytical chemistry supporting protein therapeutic (biologics) products research. The Scientist will be responsible for (but not limited to) supporting GMP release and IND stability testing of Ph. 1 through Ph. 3 clinical drug substance and drug product for protein therapeutics (biologics). The Scientist will be responsible for the analysis, evaluation and documentation of data in compliance with cGLP/GMPs and departmental SOPs. The Scientist must have strong scientific, analytical and conceptual skills. Strong written, oral and interpersonal communication skills will be necessary to work effectively in team settings.
REQUIREMENTS - QUALIFICATIONS: Scientist
Additional criteria/appropriate skills required are:
* Demonstrated proficiency in working with Compendial related testing.
* Handling of Biological and chemical reagents
* Demonstrated understanding and compliance to current cGMP/cGLP, OSHA, and FDA requirements,
* Adaptability and productivity in a demanding/challenging work environment.
* Ability to support maintenance, qualification, and calibration programs of the laboratory equipment.
* Demonstration of good documentation practices as required in a cGMP/cGLP regulated laboratory
* Demonstration of good interpersonal skills in a high throughput, active Compedial laboratory, including good communication with supervisors and co-workers and flexibility in a changing environment
* GMP requirements in a Compendial Laboratory
* Maintenance, Qualification and Calibration of laboratory equipment
* Sampling Techniques
* Testing techniques for Water Determination, Volume in Container, Particulate Matter (Light Obscuration, Microscopic analysis), Heavy Metals, A280, Weight Variation, Solution Density, Osmolality (Freezing Point, Vapor Pressure), conducitivity, and pH.
* Operation of equipments used for Compendial test such as a pH meter, osmometer (freezing point and vapor pressure), density meter and pycnometer, Karl Fischer, HIAC (Model 9703), Conductivity meter, and UV-VIS Spectrophotometer (A280). Familiarity with writing out-of-specification investigation reports.
* Computer Skills (Microsoft office programs i.e. Excel, Word, PowerPoint, etc.)
PPD is an Equal Opportunity Employer
See Information Above
PPD
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