Chemist

Essential Job Function: Test raw materials, in-process, prototype formulation drug products, finished products submitted and/or produced by the Development Lab and Contract Manufacturing using USP/NF, EP, JP or other compendial methods. Participate in the method transfer and method development activities as dictated by the project scope of the Analytical Services section of the QC function. Document the modification(s) made in the test methods and write analytical reports with tables, graphs and statistical analysis to support the method transfer and/or method validation. Able to perform instrumental analysis and troubleshoot HPLC, Dissolution, Spectrophotometry, IR, UV and GC.

 

General Information: B.S. in Chemistry a must. At least 5 years experience in pharmaceutical quality control, instrumental analysis and analytical method development/validation. Hands-on experience on HPLC Millennium Software and Dissolution required. Must be organized, detail oriented, self-motivated, cooperative and have excellent analytical skills. Able to work independently and possess computer skills including Microsoft Excel and Microsoft Word (Microsoft Access helpful).

 

This position is classified as a “safety sensitive� position and is subject to random drug testing.

 

 

 

Job Responsibilities include, but not limited to:

 

1.  Preparing standard solutions, volumetric solutions, reagent test solutions, mobile phases and samples.

2.  Calibrating pH, balances, conductivity meters, Distek Degasser, Dissolution Bath, Disintegrator, Friability equipment.

3.  Documenting and maintaining the analytical records/results in the notebook.

4.  Maintaining the Quality Control logbooks for equipment calibration, USP Reference Standards, incoming reagents, raw materials, in-process products, finished products, prototype drug formulations and stability samples.

5.  Maintaining and documenting the QC equipment and column usage.

6.  Reviewing peer chemists’ analytical results.

7.  Performing swabbing of equipment and cleaning validation testing.

8.  Performing Out of Specification investigation and documenting the results.

9.  Interfacing with the Development Laboratory and Contract Manufacturing and their clients.

10.  Validating test methods supplied by the customers.

11.  Writing and reviewing SOPs related to QC labs or analytical testing.

12.  Assisting the Group Leader in cGMP/GLP audit preparation.

13.  Other responsibilities as assigned by the Group Leader or Director, Corporate Compliance.