PPD, Inc.

Hamilton, NJ, , USA

  At PPD, you'll have the freedom to try new ideas and the ability to do something truly great. In our environment, innovation is encouraged. That's why the world's leading pharmaceutical and biotechnology companies come to us for discovery and development services. And why PPD is the best choice for you and for your career. 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.  Qualifications 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

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