Senior Bioanalytical Scientist

3 days ago


Wilmington, Delaware, United States Incyte Full time
Job Title: Senior Bioanalytical Scientist

Join Incyte's Bioanalysis team as a Senior Bioanalytical Scientist and contribute to the discovery, development, and commercialization of novel medicines in oncology and inflammation and autoimmunity.

About the Role

We are seeking a highly motivated and experienced bioanalytical scientist to provide strategic support to the discovery, nonclinical and clinical development of biologic drugs. As a Senior Bioanalytical Scientist, you will be an integral project team member representing Bioanalysis on biologics research projects to ensure delivery of high quality data within project timelines to support regulatory filings.

Key Responsibilities
  • Conduct bioanalytical method development and validation and sample analysis to support Incyte discovery and development programs.
  • Manage resources and prioritize studies in close communications with different groups including bioanalytical scientists, toxicology, pharmacology, DMPK, clinical PK, clinical operations, and clinical scientist.
  • Provide sample analysis in support of clinical, toxicology, DMPK, pharmacology, and other studies.
  • Provide data to pharmacokineticists, toxicokineticists, DMPK, line management, and project teams as needed.
  • Compliance with GLP and GCP regulations, follow company policies and SOPs, as applicable.
  • Closely working with Quality Assurance to ensure data quality and compliance, as applicable.
  • Review bioanalytical data and bioanalytical reports.
  • Contribute to clinical study reports and IND/NDA submission documents, as required.
  • Troubleshoot assay and instrumentation problems.
  • Train and assist junior scientists in the group on large molecule PK and Immunogenicity method optimization and troubleshooting.
  • Present study results to working group as needed.
  • Act as a bioanalytical phase Principle Investigator, if needed.
  • Manage bioanalytical studies at CROs, if required.
Qualifications
  • BS/MS/PhD degree or equivalent in Life Sciences or related discipline.
  • At least 10 years (BS) /7 years (MS)/5 year (PhD) related experience in pharmaceutical companies or CROs.
  • Knowledge of DMPK is required.
  • Strong hands-on experience in large molecule PK assays and Immunogenicity assays, including Anti-drug Antibody (ADA) and Neutralizing Antibody (NAb assays).
  • A broad knowledge of drug discovery and development, especially DMPK knowledge, is desirable.
  • Must have GLP and GCP knowledge and experience working in a regulated environment, if assigned tasks in regulated bioanalysis.
  • Excellent oral and written communication skills are essential along with strong organizational skills.


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