Data Reviewer KBI Biopharma
THIS JOB HAS EXPIRED Responsibilities include:
Perform timely review of cGMP data from HPLC, ELISA, CE, etc. with a high focus on data quality and integrity to ensure accuracy, completeness, and compliance. Requires 3-5 years of pharmaceutical/biotechnology experience and a minimum of 2 years performing data review. Advanced knowledge of analytical methods, testing and related instrumentation. Advanced knowledge of cGMPs and data integrity
Must have experience with LC-MS/MSMS analysis of peptides and proteins. Hands-on experience with bio-analytical techniques such as HPLC, SDS-CGE, IEF, Fluorescence and other techniques applicable to monitor physical and chemical stability of the proteins; maintains and updates knowledge of instrumentation and maintenance.
Maintains familiarity with current scientific literature; maintains professional expertise through familiarity with scientific literature.
Responsible for developing/maintaining a current understanding of cGMP and other regulatory requirements.
Notebook upkeep and writing skills.
BS/MS/PhD in biophysical/biochemical sciences, pharmaceutical sciences, biochemical engineering or other related discipline.
Industry experience with analytical method development experience for proteins, antibodies, peptides or vaccines.
Experience with analytical instrumentation
Excellent verbal and written communication skills; experience working in a cGMP environment preferred.
||PO Box 15579 |
1101 Hamlin Road
Durham, NC 27704
THIS JOB HAS EXPIRED