Analytical Chemist

QC Analytical Chemist - Ohio



 

Responsibilities:



 

The QC Analytical Chemist performs process, release and stability testing of biopharmaceutical products in a cGMP quality environment utilizing predefined chemical and biochemical assay methods.  Additional responsibilities include:Individual will perform testing during phases of Production that include incoming raw materials, process samples and finished bulk product Perform analysis using analytical chemistry techniques and procedures on product in-process and release, as well as stability assaysPerform transfer of analytical testing methodsAnalyze and report data compared to established specificationsWrite/Revise technical documents including lab procedures, protocols and technical reportsUtilize computer systems for generating data and writing reports; and follow all established laboratory, regulatory, safety, and environmental proceduresConduct daily lab and equipment maintenance; calibrate, operate and maintain a variety of lab instrumentation Interpret and apply US and EU regulations as they apply to the analytical laboratory and production facilityPerform training on laboratory methods and instrumentation

Qualifications:



 

·  BS degree in Chemistry, Biochemistry or Biology with 1+ years experience.

·  Working knowledge of Analytical Instrumentation including HPLC, GC, UV/Vis, and standard chemistry techniques.

·  Excellent math and technical writing skills.

 

Company Profile:

This company develops and manufactures liquid and lyophilized sterile pharmaceutical products for its customers. They are widely acknowledged as a world leader in contract manufacturing of parenteral pharmaceuticals and are recognized as the oldest, largest and most experienced manufacturer of lyophilized products in the United States.  To date, they have produced over 800 drugs.  This facility is expanding for a 5th time in the last decade and is looking for top talent.