Analytical Method Development, Biotech and Pharmaceutical, Chemistry, Documentation, ICH Regulations, Industry/Trade Press, Laboratory, Liquid Chromatography-Mass Spectrometry (LC-MS), Pharmaceutical Analysis, Presentation/Verbal Skills, Quality Management, Reporting Skills, Research Skills, Small Molecules, Specimen Analysis, Strategic Planning, United States Citizen, Writing Skills
Job Details:
Role: Nitrosamine Researcher
POP: 12+ months
Location: St. Louis, MO (On-site)
US Citizen
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.
C
Creative Global Consulting