at Incyte Corporation in Wilmington, Delaware, United States
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 sample management support of discovery and development programs under GLP standards
Essential Functions of the Job (Key responsibilities)
Receive biospecimen samples and compounds including frozen, refrigerated, and ambient materials
Document sample information in Watson LIMS including study design, sample entry/receipt, inventory, and reconciliation.
Document sample quality concerns, provide feedback, and perform discrepancy resolution.
Coordinate with internal and external clients to ensure all shipments are tracked and received.
Maintain an inventory of all samples in Watson LIMS/ELN.
Pull samples for analytical runs, coordinate sample disposal and shipment to external vendors or archive as needed.
Perform routine and non-routine maintenance on controlled environment equipment.
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.
Contribute to clinical study reports and IND/NDA submission documents as required
Train junior scientists and assist inexperienced users on sample management procedures.
Contribute to maintenance of GLP laboratory through SOP revisions.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BS or equivalent in, life sciences or a related discipline.
At least 8-years regulated bioanalysis experience in pharmaceutical companies and/or bioanalytical CROs.
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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