Nitrosamine Researcher

Nitrosamine Researcher

Client: Food and Drug Administration (FDA)

POP: 12+ months

Location: St. Louis, MO

SCOPE 

The researcher will be responsible for conducting, documenting, and reporting the following laboratory work in accordance with OPQR quality procedures

REQUIRED SKILLS

• A master’s degree in a science-related area (chemistry or pharmaceutical science preferred) with a minimum of two (2) years of experience in pharmaceutical analysis; or a doctoral degree in a science-related area (chemistry or pharmaceutical science preferred).

• Experience with liquid chromatography and mass spectrometry;

• Expertise in method development and validation following ICH guidelines;

• Capability to design and execute scientific studies;

• Strong written and oral communication;

• Ability to prepare technical reports or manuscripts for peer review and popular (trade) publications;

• Familiarity with working in a quality management system environment.

TASKS

• Developing analytical methods for the identification and quantitation of small molecule impurities by liquid chromatography-mass spectrometry (LC-MS);

• Analyzing samples using the developed methods to evaluate the extension of impurity contamination, to understand the contributing factors for impurity formation and to support the development of mitigation strategy.