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Sr. Research Associate, Analytical Development
3 months ago
Salary: $80-100k depending on experience
Summary:
The Analytical team is seeking an experienced Sr. Research Associate who is interested in pursuing a career in developing protein biologics. The primary focus of the Sr. RA will be to develop Cell-based, ELISA, HPLC, and/or LC-MS methods. The Sr. RA will work under the guidance of analytical scientists and with process development scientists to identify and characterize protein biologics. This position will interface with the Quality Control testing group as methods are transferred into that group for cGMP testing and may interface with external clients.
Responsibilities:
- Perform and review routine wet chemistry/raw material assays and ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/IEF) and HPLC.
- Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
- May train/supervise the experimental work of more junior analysts and may be a member of interdepartmental/tech transfer teams.
- Develop, review, revise and write test methods, standard operating procedures and may perform trending analysis.
- May be designated as study lead for validation projects, investigations and method development projects.
- Previous experience in either HPLC/CE or Potency/ELISA assay methodologies is required.
- Knowledgeable of cGMPs as well as industry regulations that apply to job functions. Participates in regulatory inspections.
- Support continuous improvement initiatives.
Qualifications:
- Bachelors with 4+ years or Masters with 2+ years of industry experience working in a QC or Analytical lab
- Analytical testing and equipment utilizing analytical biochemistry methods
- Potency/ELISA and/or HPLC experience is requirred
- Experience with protein characterization, electrophoresis, chromatography, aseptic techniques, cell culture, LAL and assay validation/qualification.
