Research Investigator, Biologics Analytical Development
Incyte
5 hours ago
On-site
Wilmington, DE
Clinical Research and Development
Job Summary (Primary Function)
- Design and conduct experiments to develop new analytical methods to support release testing, stability, and characterization of a biologics pipeline (including familiarity with ICH guidance and strong interpersonal/communication skills).
Responsibilities (Essential Functions)
- Design experiments; generate and interpret data to support CMC analytical activities.
- Conduct experiments using ELISA/cell/SPR-based assays to support cell line development, process/formulation development, comparability, and structure-function elucidation for regulatory filings.
- Perform routine sample testing using analytical methods such as ELISA, PCR, SPR, etc.
- Author notebooks, protocols, SOPs, and reports.
- Present data summaries and study conclusions at internal scientific meetings.
- Participate in analytical method transfer/qualification.
- Operate and maintain analytical instrumentation in compliance with safety rules and procedures.
Qualifications
- Master’s degree with 5–7 years, or Ph.D., in biochemistry/biological/pharmaceutical sciences (or equivalent) with relevant laboratory experience in analytical techniques in pharma/biotech or academic settings.
- Experience with biophysical/biochemical methods (protein assays, ELISA, PCR, SPR, higher order structure analysis, etc.).
- Experience with analytical method development, qualification, method transfer, and validation (valued).
- Familiarity with SoftMax Pro, LIMS, and/or ELN systems (preferred; training provided if needed).
- Excellent written, verbal, and organizational skills required.
- Design and conduct experiments to develop new analytical methods to support release testing, stability, and characterization of a biologics pipeline (including familiarity with ICH guidance and strong interpersonal/communication skills).
Responsibilities (Essential Functions)
- Design experiments; generate and interpret data to support CMC analytical activities.
- Conduct experiments using ELISA/cell/SPR-based assays to support cell line development, process/formulation development, comparability, and structure-function elucidation for regulatory filings.
- Perform routine sample testing using analytical methods such as ELISA, PCR, SPR, etc.
- Author notebooks, protocols, SOPs, and reports.
- Present data summaries and study conclusions at internal scientific meetings.
- Participate in analytical method transfer/qualification.
- Operate and maintain analytical instrumentation in compliance with safety rules and procedures.
Qualifications
- Master’s degree with 5–7 years, or Ph.D., in biochemistry/biological/pharmaceutical sciences (or equivalent) with relevant laboratory experience in analytical techniques in pharma/biotech or academic settings.
- Experience with biophysical/biochemical methods (protein assays, ELISA, PCR, SPR, higher order structure analysis, etc.).
- Experience with analytical method development, qualification, method transfer, and validation (valued).
- Familiarity with SoftMax Pro, LIMS, and/or ELN systems (preferred; training provided if needed).
- Excellent written, verbal, and organizational skills required.