Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
Sr. Research Scientist, Bioanalytical (Regulated)
This position is responsible for providing bioanalytical support to projects in development from pre-clinical studies to clinical stages.
Summary of the Essential Functions of the Job
Perform method development and validation of bioanalytical methods for small molecules in biological fluids using LC-MS/MS methodologies in a GLP environment.
Conduct sample analysis and provide bioanalytical support to clinical and non-clinical studies at Incyte.
Report data to line management, pharmacokineticists/toxicokineticists, and data management.
Draft bioanalytical study plans and bioanalytical reports for both method validation and sample analysis studies.
Contribute to clinical study reports and regulatory submission activities, if required.
Contribute to quality assurance (QA) audits through direct interaction with QA auditors as well as responding to QA findings.
Perform other bioanalytical work as assigned based on project and Company needs.
Take part in general regulated bioanalytical laboratory operations including: maintenance and calibration of equipment, ordering lab supplies, etc.
BS/MS degree or equivalent in Life Sciences or related discipline
At least 7 years (BS) / 5 years (MS) regulated bioanalysis experience in pharmaceutical companies and/or bioanalytical CROs, with high success rate.
Hands-on experience with sample preparation techniques, LC separations, and Sciex mass spectrometers. Efficient use of Analyst software and Watson LIMS.
Must have good knowledge of regulatory guidelines/requirements regarding bioanalysis. Able to follow SOPs.
Good organizational, documentation, and communication skills. Must be a team player. Self-motivated.
Basic knowledge of DMPK and overall drug discovery and development process is required.
Experience in ligand binding assays is desirable but not required.
Experience with ELN(s) is desirable but not required.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.