HPLC Chemists (R&D)

A leading pharmaceutical company in the city of Irvine has great opportunities for Chemists for their Research and Development Department!!

Position Summary:
Conduct research and experimentation on raw material and finished product method development and validation, quantitative and qualitative analysis, and improvement of analytical methodologies by performing the following duties.

Job Duties and Responsibilities:

Follow the method to test raw material and impurities/degradants in the finished products.

Follow the method to test new chemical entities according to USP and FDA guidelines.

Work with Sr. Chemist to develop the stability-indicating testing methods for drug products.

Analyze organic and inorganic compounds to determine chemical and physical properties.

Perform cleaning validation analyses of production equipment.

Coordinate with Quality Control department to smoothly transfer the method to QC chemists.

Responsible for calculations and recording results of all tests in lab books and laboratory reports according to SOPs and GMPs.

Prepare the Quality Control Protocol and Stability-Indicating Testing Summary.

Other duties may be assigned.

Experience:

BS in Chemistry or science related field

One or more year related experience and/or training

Equivalent combination of education and experience will be given consideration also.

Experience with Waters Millenium Software/PDA detector/HPLC method development and trouble-shooting




job Requirements


Please refer to the job description above.