Nitrosamine Research Scientist

The Nitrosamine Researcher II will perform pharmaceutical analytical research focused on identifying and quantifying small-molecule impurities, particularly nitrosamines, using LC-MS techniques. The role involves analytical method development and validation, sample analysis, scientific study design, interpretation of impurity formation, and supporting mitigation strategies. The researcher will work in a quality-controlled laboratory environment and prepare technical reports/manuscripts.

Develop analytical methods using LC-MS/LC-MS/MS for identification and quantification of small-molecule impurities, including nitrosamines.
Perform liquid chromatography and mass spectrometry analysis of pharmaceutical samples.
Evaluate the extent of impurity contamination in samples.
Investigate factors contributing to impurity/nitrosamine formation.
Support development of impurity mitigation strategies.
Design and execute scientific and analytical studies.
Develop and validate analytical methods according to ICH guidelines.
Analyze, interpret, and document laboratory data accurately.
Conduct laboratory activities in accordance with quality management system (QMS) procedures and applicable quality standards.
Prepare detailed technical reports, study reports, and scientific documentation.
Prepare manuscripts or technical content for peer-reviewed and trade publications when required.
Communicate analytical findings and study results clearly to technical and cross-functional teams.
Maintain accurate laboratory records and ensure data integrity and traceability.
Collaborate with R&D, QA/QC, product safety, process development, and regulatory teams.
Support investigations into impurity sources and contribute technical expertise to product safety and regulatory compliance.
Follow applicable FDA/GMP/quality requirements and laboratory safety procedures.