Advanced Research Associate - Chemistry

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.

• 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.

• 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.

• Day‑one competitive insurance: medical, dental, vision, life, short‑term disability, long‑term disability, pet, legal, d.
• 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.