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Research Scientist/Sr Research Scientist, DMB

at Incyte Corporation in Wilmington, Delaware, United States

Job Description

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.

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.

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 bioanalytical support of discovery and development compounds under GLP standards.

Essential Functions of the Job (Key responsibilities)

 

Perform bioanalytical method development and validation for small molecules in biological fluids using LC-MS/MS methodologies in a regulated environment.

Provide sample analysis in support of clinical, toxicology and other studies.

Provide data to pharmacokineticists, toxicokineticists, line management and project teams as needed.

Compliance with GLP and GCP regulations, follow company policy and SOPs.

Contribute to Quality Assurance audits through direct interaction with auditors as well as providing resolutions to QA audit findings.

Draft bioanalytical study plans according to study protocols.

Prepare bioanalytical method validation and sample analysis reports

Peer review bioanalytical data and bioanalytical reports.

Contribute to clinical study reports and IND/NDA submission documents as required

Troubleshoot assay problems and instrumentations.

Train junior scientists and assist inexperienced users with operation of the LC/MS systems, including method optimization, troubleshooting, and batch set-up.

Present study results to working group as needed.

Contribute to maintenance of GLP laboratory through SOP revisions.

Qualifications (Minimal acceptable level of education, work experience, and competency)

 

BS or equivalent in analytical chemistry, life sciences or a related discipline.

At least 8-years regulated bioanalysis experience in pharmaceutical companies and/or bioanalytical CROs.

Strong skills in bioanalytical method development, validation and samples analysis.

Good knowledge of GLP and GCP regulations and familiar with the trends of the bioanalytical regulatory landscape.

Prior experience with Watson LIMS, Sciex Analyst, and electronic laboratory notebooks preferred.

Knowledge of DMPK and overall drug discovery and development process.

Ability of understanding non-clinical and clinical study designs is required

Excellent organizational, documentation, and communication skills

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.

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We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.        

        

 

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Job Posting: 826281

Posted On: Jul 24, 2021

Updated On: Aug 14, 2021