Advanced Research Associate - Chemistry
Bio-Techne
June 26, 2026
On-site
San Marcos, CA
Clinical Research and Development
Position Summary:
- Develop controls, calibrators, working solutions, and intermediates according to approved SOPs.
- Develop quality products on schedule; apply basic laboratory research concepts, theories, terminology, and practices.
Duties and Responsibilities (Research Associate):
- Develop and manufacture OEM diagnostic controls and calibrators for clinical chemistry and immunoassay applications (e.g., cardiac markers, immunochemistry, lipids, urinalysis, coagulation, tumor markers; protein/small molecule analytes).
- Support new product development (formulation development, optimization, refinement).
- Execute manufacturing/development per approved SOPs; maintain complete, accurate, contemporaneous GMP documentation.
- Design and execute controlled experiments for troubleshooting, root cause analysis, process optimization, and formulation development.
- Prepare technical summaries/reports for design control (feasibility, development, validation, transfer).
- Design, validate, and transfer product formulations per design control/change management.
- Perform in-process testing, calculations, adjustments to meet specifications.
- Analyze raw materials, intermediates, and final products using automated/manual analytical instrumentation.
- Verify instrumentation/analyzers/point-of-care devices; perform/confirm calibration and maintenance as required.
- Prepare solutions using volumetric/gravimetric techniques; apply safe handling.
- Author/review/revise SOPs, work instructions, QCRs, and quality documentation; implement via formal change control.
- Perform processing steps (centrifugation, filtration, diafiltration, column separation, buffer exchanges).
- Design/execute/analyze stability studies; trend and report data.
- Perform aseptic techniques (sterile filtration, filling, capping, microbial plating) per GMP.
- Support equipment/process validation (IQ/OQ/PQ).
- Assist with technical transfer and training.
- Contribute to continuous improvement; maintain lab cleanliness and equipment readiness; support special projects.
Minimum Job Requirements:
- Bachelor’s degree in Chemistry, Biochemistry, Biological Science, or related field.
- 1–5 years work experience in In Vitro diagnostics, medical device, pharmaceutical, or related industry.
Benefits:
- Day-one competitive insurance: medical, dental, vision, life, short-term disability, long-term disability, pet, legal, ID shield.
- 401(k), ESPP, HSA, FSA, Dependent Care FSA.
- Career development (mentorship, training, tuition reimbursement, etc.); employee resource groups, volunteer paid time off, events/charity drives.
- Accrued leave with paid holidays, paid time off, paid parental leave.
- Develop controls, calibrators, working solutions, and intermediates according to approved SOPs.
- Develop quality products on schedule; apply basic laboratory research concepts, theories, terminology, and practices.
Duties and Responsibilities (Research Associate):
- Develop and manufacture OEM diagnostic controls and calibrators for clinical chemistry and immunoassay applications (e.g., cardiac markers, immunochemistry, lipids, urinalysis, coagulation, tumor markers; protein/small molecule analytes).
- Support new product development (formulation development, optimization, refinement).
- Execute manufacturing/development per approved SOPs; maintain complete, accurate, contemporaneous GMP documentation.
- Design and execute controlled experiments for troubleshooting, root cause analysis, process optimization, and formulation development.
- Prepare technical summaries/reports for design control (feasibility, development, validation, transfer).
- Design, validate, and transfer product formulations per design control/change management.
- Perform in-process testing, calculations, adjustments to meet specifications.
- Analyze raw materials, intermediates, and final products using automated/manual analytical instrumentation.
- Verify instrumentation/analyzers/point-of-care devices; perform/confirm calibration and maintenance as required.
- Prepare solutions using volumetric/gravimetric techniques; apply safe handling.
- Author/review/revise SOPs, work instructions, QCRs, and quality documentation; implement via formal change control.
- Perform processing steps (centrifugation, filtration, diafiltration, column separation, buffer exchanges).
- Design/execute/analyze stability studies; trend and report data.
- Perform aseptic techniques (sterile filtration, filling, capping, microbial plating) per GMP.
- Support equipment/process validation (IQ/OQ/PQ).
- Assist with technical transfer and training.
- Contribute to continuous improvement; maintain lab cleanliness and equipment readiness; support special projects.
Minimum Job Requirements:
- Bachelor’s degree in Chemistry, Biochemistry, Biological Science, or related field.
- 1–5 years work experience in In Vitro diagnostics, medical device, pharmaceutical, or related industry.
Benefits:
- Day-one competitive insurance: medical, dental, vision, life, short-term disability, long-term disability, pet, legal, ID shield.
- 401(k), ESPP, HSA, FSA, Dependent Care FSA.
- Career development (mentorship, training, tuition reimbursement, etc.); employee resource groups, volunteer paid time off, events/charity drives.
- Accrued leave with paid holidays, paid time off, paid parental leave.