Research Associate - Chemistry
Bio-Techne
August 31, 2026
On-site
San Marcos, CA
Clinical Research and Development
Position Summary
- Responsible for developing controls, calibrators, working solutions, and intermediates according to approved SOPs in an in vitro diagnostics environment.
- Responsible for developing quality products on schedule.
Duties and Responsibilities (Research Associate)
- Develop OEM in-vitro diagnostic controls and calibrators (Cardiac, Immunoassay, Urinalysis, Tumor Markers, Drug monitoring, Proteins).
- Assist in development of new products/methods; optimize/refine current product lines.
- Create products using approved procedures; maintain detailed records.
- Prepare summary reports for Feasibility, Development, and Transfer.
- Perform in-process analyses; adjust to bring analytes into specification.
- Use basic troubleshooting and root cause analysis.
- Manufacture liquid chemistry and serum-based bulks, intermediates, stock solutions, and raw materials.
- Verify instruments/procedures are operating correctly; perform maintenance/calibrations as needed.
- Measure quantities volumetrically and gravimetrically; apply chemical/biochemical handling knowledge.
- Continually evaluate/create work instructions, QCRs, SOPs, and other documents; modify via change process.
- Perform processing steps (centrifugation, diafiltration, in-process filtration, column separation).
- Perform final release testing on analytical instruments.
- Perform aseptic procedures (filtration, filling, capping, microbial plating).
- Assist in training, validation testing, assay testing for Value Assignment, and new product transfer/procedure development.
- Maintain laboratory/equipment cleanliness; special projects as assigned; other duties as required.
Minimum Job Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Biological Science, or related field preferred; 1–3 years’ experience in in vitro diagnostics, medical device, pharmaceutical, or related industry required.
- Responsible for developing controls, calibrators, working solutions, and intermediates according to approved SOPs in an in vitro diagnostics environment.
- Responsible for developing quality products on schedule.
Duties and Responsibilities (Research Associate)
- Develop OEM in-vitro diagnostic controls and calibrators (Cardiac, Immunoassay, Urinalysis, Tumor Markers, Drug monitoring, Proteins).
- Assist in development of new products/methods; optimize/refine current product lines.
- Create products using approved procedures; maintain detailed records.
- Prepare summary reports for Feasibility, Development, and Transfer.
- Perform in-process analyses; adjust to bring analytes into specification.
- Use basic troubleshooting and root cause analysis.
- Manufacture liquid chemistry and serum-based bulks, intermediates, stock solutions, and raw materials.
- Verify instruments/procedures are operating correctly; perform maintenance/calibrations as needed.
- Measure quantities volumetrically and gravimetrically; apply chemical/biochemical handling knowledge.
- Continually evaluate/create work instructions, QCRs, SOPs, and other documents; modify via change process.
- Perform processing steps (centrifugation, diafiltration, in-process filtration, column separation).
- Perform final release testing on analytical instruments.
- Perform aseptic procedures (filtration, filling, capping, microbial plating).
- Assist in training, validation testing, assay testing for Value Assignment, and new product transfer/procedure development.
- Maintain laboratory/equipment cleanliness; special projects as assigned; other duties as required.
Minimum Job Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Biological Science, or related field preferred; 1–3 years’ experience in in vitro diagnostics, medical device, pharmaceutical, or related industry required.