Job Summary (Primary Function)
- The Research Investigator, Biologics Analytical Development designs and conducts experiments to develop new analytical methods supporting release testing, stability, and characterization of a growing biologics pipeline.
Responsibilities (Essential Functions)
- Design experiments; generate and interpret data to support CMC analytical activities.
- Conduct experiments using ELISA, cell-based assays, and SPR-based assays to support cell line development, process and formulation development, comparability, and structure-function elucidation for regulatory filings.
- Perform routine sample testing using analytical methods such as ELISA, PCR, and SPR.
- 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
- Masterβs degree (5β7 years) or Ph.D. in biochemistry, biological sciences, or pharmaceutical sciences, or equivalent experience; relevant laboratory experience in a variety of analytical techniques in pharma/biotech or academic settings.
- Experience with biophysical and biochemical methods (protein assays, ELISA, PCR, SPR, higher order structure analysis, etc.).
- Analytical method development, qualification, method transfer, and validation experience valued.
- SoftMax Pro, LIMS, and/or ELN familiarity preferred (training provided if needed).
- Excellent written, verbal, and organizational skills required.