Sr. Research Scientist, Bioanalytical (Regulated)

Incyte Wilmington , DE 19801

Posted 2 weeks ago

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.

Minimum Requirements

  • 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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr Director Clinical Research Scientist

Incyte

Posted 1 week ago

VIEW JOBS 3/19/2020 12:00:00 AM 2020-06-17T00:00 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) This position is responsible for working with the physicians within Clinical Development to provide clinical research support for programs as assigned by phase or therapeutic area. Essential Functions of the Job (Key responsibilities) * Development of protocols for clinical studies. * Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans * Drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions. * Monitor, review and summarize safety and efficacy data in ongoing studies. * Represent clinical development on project teams. * Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design. * Clinical lead for study abstracts, posters, oral presentations and manuscripts for assigned studies. * Serve as liaison to project teams, CRO's, Clinical sub-teams, and others. * Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest. Qualifications (Minimal acceptable level of education, work experience, and competency) * Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred. * Minimum of 8 years of experience in research with at least 5 years of drug development experience are required. Alternative drug development experience will be considered. * Prior Oncology Drug Development experience is preferred. * Ability to work independently, multi-task, and work in a fast-paced environment. * Excellent written and oral communication skills. * Strong Analytical ability. * Ability to accommodate up to 20% travel or as business dictates 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. Incyte Wilmington DE

Sr. Research Scientist, Bioanalytical (Regulated)

Incyte