Research Associate - Chemistry
Bio-Techne
4 hours ago
On-site
San Marcos, CA
Clinical Research and Development
Position Summary
- Develop in-vitro diagnostic controls, calibrators, working solutions, and intermediates according to approved SOPs in an in-vitro diagnostics environment.
- Develop quality products on schedule.
Duties and Responsibilities (Research Associate)
- Develop OEM in-vitro diagnostic controls and calibrators (e.g., Cardiac, Immunoassay, Urinalysis, Tumor Markers, Drug monitoring, Proteins).
- Assist in development of new products/methods; optimize or refine current product lines.
- Create products using approved procedures; maintain detailed, accurate records.
- Prepare summary reports for Feasibility, Development, and Transfer.
- Perform in-process analyses; adjust to bring analytes into specification.
- Apply basic troubleshooting and root cause analysis.
- Manufacture liquid chemistry and serum-based bulks, intermediates, stock solutions, and raw materials.
- Verify instrumentation/procedures; perform maintenance and calibrations as needed.
- Measure quantities volumetrically and gravimetrically.
- Create/evaluate work instructions, QCRs, SOPs, and other documents; modify through formal change process.
- Perform processing steps (e.g., centrifugation, diafiltration, in-process filtration, column separation).
- Perform final release testing.
- Perform aseptic procedures (filtration, filling, capping, microbial plating).
- Assist in training; assist validation testing of equipment and processes.
- Perform assay testing for Value Assignment.
- Assist in new product transfer and required procedure development.
- Maintain laboratory and equipment cleanliness; special projects as assigned.
Minimum Job Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Biological Science, or related field preferred.
- Required: 1–3 years work experience in in-vitro diagnostics, medical device, pharmaceutical, or related industry.
Benefits (if applicable)
- Competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal/ID shield.
- Develop in-vitro diagnostic controls, calibrators, working solutions, and intermediates according to approved SOPs in an in-vitro diagnostics environment.
- Develop quality products on schedule.
Duties and Responsibilities (Research Associate)
- Develop OEM in-vitro diagnostic controls and calibrators (e.g., Cardiac, Immunoassay, Urinalysis, Tumor Markers, Drug monitoring, Proteins).
- Assist in development of new products/methods; optimize or refine current product lines.
- Create products using approved procedures; maintain detailed, accurate records.
- Prepare summary reports for Feasibility, Development, and Transfer.
- Perform in-process analyses; adjust to bring analytes into specification.
- Apply basic troubleshooting and root cause analysis.
- Manufacture liquid chemistry and serum-based bulks, intermediates, stock solutions, and raw materials.
- Verify instrumentation/procedures; perform maintenance and calibrations as needed.
- Measure quantities volumetrically and gravimetrically.
- Create/evaluate work instructions, QCRs, SOPs, and other documents; modify through formal change process.
- Perform processing steps (e.g., centrifugation, diafiltration, in-process filtration, column separation).
- Perform final release testing.
- Perform aseptic procedures (filtration, filling, capping, microbial plating).
- Assist in training; assist validation testing of equipment and processes.
- Perform assay testing for Value Assignment.
- Assist in new product transfer and required procedure development.
- Maintain laboratory and equipment cleanliness; special projects as assigned.
Minimum Job Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Biological Science, or related field preferred.
- Required: 1–3 years work experience in in-vitro diagnostics, medical device, pharmaceutical, or related industry.
Benefits (if applicable)
- Competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal/ID shield.