Clinical Laboratory Scientist
Palo Alto, CA, USA
Company Description ImpriMed is a precision-medicine company that combines live-cell functional testing with AI to personalize cancer treatment. Our xCellSense platform measures how a patient's own cancer cells respond to a panel of drugs, and our models integrate that readout with clinical data so oncologists can choose therapy on evidence rather than averages. We have run this platform at scale in comparative oncology and are now building the human clinical laboratory in Palo Alto.
Role Description ImpriMed is validating a flow cytometry assay for CLIA accreditation. We are looking for a California-licensed CLS to run that validation on our BD FACSLyric. Part-time to start (about 12–20 hrs/week for three months), with a defined path to full-time ownership of the assay. For the first three months, your job is the validation. After that, your job is the assay.
- Run the analytical validation of the designated flow cytometry assay on the BD FACSLyric to support CLIA accreditation
- Process human blood and bone marrow specimens; perform live-cell preparation, staining, acquisition, gating, and quantitative analysis.
- Establish instrument setup, daily QC, compensation, acquisition templates, gating procedures, and acceptance criteria—and document all of it well enough to support and successfully pass an inspection.
- Write and revise validation protocols, SOPs, worksheets, and validation summary reports.
- Investigate out-of-specification results and document deviations and corrective actions.
- Support CLIA certification, California CDPH licensure, and accreditation readiness alongside our Regulatory and Quality team.
- After conversion: perform high-complexity patient testing, own the flow cytometry workflow, support ongoing optimization, and help train the testing personnel who come after you.
Qualifications and Requirments
- Active California CLS Generalist license (CDPH Laboratory Field Services), in good standing (nonnegotiable).
- Bachelor's degree or higher in clinical laboratory science, medical technology, biology, immunology, or a related field.
- Qualified as high-complexity testing personnel under CLIA.
- 3+ years of clinical laboratory experience with substantial hands-on clinical flow cytometry.
- You can run a clinical cytometer independently—setup, daily QC, compensation, gating, performance review, and troubleshooting when it misbehaves at 6pm.
- Experience building or working with user-defined panels, not only off-the-shelf pre-set kits.
- Strict adherence to documentation requirements in a CLIA environment: SOPs, QC records, deviations, corrective actions.
- Aseptic handling of primary human specimens or mammalian cell culture.
- Available onsite in Palo Alto on a predictable schedule, roughly 12–20 hrs/week, and genuinely interested in going full-time afterward.
Nice to Have
- You have validated or verified a flow cytometry LDT before, and familiarity with CLSI H62 guidelines.
- BD FACSLyric and BD FACSuite experience.
- Leukemia, multiple myeloma, or minimal residual disease (MRD) background.
- You have been through a lab's first CLIA certification, state license, or CAP inspection.
- SCYM(ASCP) or a comparable cytometry credential.
- Cell viability assays, functional cellular assays, or drug-response metrics (IC50, AUC, Emax).
- FCS Express, or Infinicyt; LIS and electronic QC documentation.