GENERAL SUMMARY:
The Laboratory Assay Development Scientist within the Pathology and Laboratory
Medicine team will support the development of assays using cutting-edge technologies.
Planning and executing experiments, performing data analysis, and documenting
findings to implement LDT (Laboratory Developed Tests) assays as translational
research to clinical use. Effectively communicate technical results to both technical and
non-technical stakeholders. Adaptability, quick learning, and troubleshooting skills are
essential to overcome technical challenges in protocol development. This role offers a
stimulating blend of technical expertise, collaborative teamwork, and the opportunity to
make a meaningful impact in the field of laboratory diagnostics for applications in
Immunohistochemistry, Microbiology infectious diseases, Mass Spectrometry, or
Cytogenetics/Molecular diagnostics.
PRINCIPLE DUTIES AND RESPONSIBILITIES:
1. Researches, designs, organizes, and executes key experiments leading to the
successful development of diagnostic (LDT) assays translated into clinical care
utility.
2. Implements new assays and designs workflow for high throughput testing
capabilities.
3. Trains pathology staff in new testing procedures.
4. Assesses and evaluates the design and performance characteristics of new
instrumentation, equipment, and assays for use in the clinical testing production
environment.
5. Effectively train Medical Laboratory Scientist as assay converts to clinical utility and
ramp up production.
ADDITIONAL DUITES:
- Leads assay development projects for LC-MS/MS under the direction of Chemistry Directors and Manager.
- Guides Chemistry MLS staff in supporting development projects and transferring assays to production.
- Maintains and improves existing production assays on LC-MS/MS systems.
- Provides assistance to the Director for quality monitors, review of technical/regulatory manuals and other technical duties.
- Maintains and troubleshoots LC-MS/MS instrumentation. Researches future analytes for consideration for assay development projects for LC-MS/MS.
EDUCATION/EXPERIENCE REQUIRED:
1. Bachelor's degree in a chemical, physical, biological, or clinical laboratory
science or medical technology from a four-year college or university required.
2. Master's Degree or better in a chemical, physical, biological science
preferred.
3. Assay/IVD development experience preferred.
4. Understanding of the theory and scientific principles of laboratory testing as
well as the technical, procedural, and problem-solving aspects including, but
not limited to Chemistry, Microbiology, Mass Spectrometry, Histology,
Immunohistochemistry, or In-situ hybridization.
CERTIFICATIONS/LICENSURES REQUIRED:
Certification as the technologist level from a nationally recognized national
agency such as, ASCP, NCA, ASM, AABB, ACS, HEW, or equivalent is required
with a minimum of 1 year experience performing high-complexity testing.
OR
Successful completion of a NAACLS accredited Medical Laboratory Scientist
program. AND 6 or more years of relevant industry or clinical experience in a
related field to laboratory specialty discipline.
OR
MSc/BSc with 2+ years of biotech/pharma industry experience, or equivalent
experience with laboratory specialty discipline
Additional Information
- Organization: Henry Ford Hospital - Detroit Main Campus
- Department: OPD - Chemistry
- Shift: Day Job
- Union Code: Not Applicable
Henry Ford Health System
Feb 26, 2025