The Senior Research Scientist will play a key role on the Extractables and Leachables (E&L) team in the Analytical Development Department. By utilizing various types of mass spectrometers, you will develop, validate, and implement new analytical procedures for testing raw materials and extractable/leachable samples for impurities.
Responsibilities
- Perform complex laboratory analysis of pharmaceutical products and proficiently use various LC-MS(MS) instrumentation, calculate and analyze data and record data in adherence with Curia SOP's and industry practices
- Perform qualitative and quantitative analysis of extractable and leachable samples to identify and quantify trace organic compounds by High Resolution Accurate Mass LC-MS(MS)
- Act as an individual contributor or analytical leader on multiple projects, including interacting with clients, reviewing and evaluating data, and writing analytical reports and protocols
- Develop and validate LC-MS based analytical methods for trace organic compounds, for example extractables/leachables or genotoxic impurities, to support drug substance and drug product release
- Collaborate with peer scientists on impurity identification activities
Qualifications
- Ph.D. in Organic or Analytical Chemistry, or other applicable natural science field OR; Master's degree and 4 years of relevant experience OR; Bachelor's and 7 years of relevant experienced
- Chemical Hygiene training
- Method development of LC-MS assays for small molecules
- Instrumentation and Systems Preferred: Thermo Orbitrap, Xcalibur, TraceFinder, and Compound Discover