Assay Development Specialist - Histology & Validation Expert

NeoGenomics Laboratories

Fort Myers (FL)

On-site

USD 55,000 - 75,000

Full time

14 days+

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Job summary

NeoGenomics Laboratories is seeking an Assay Development Specialist I in Anatomic Pathology to manage validations and optimize tests in Histology, ISH, IHC, and Image Analysis at our Fort Myers site. You will collaborate with the AP department to sustain assays and instrumentation and contribute to regulatory compliance.

The role requires a solid lab science background, ASCP HT/HTL credentials, and 2 years of Histology experience, with opportunities to mentor junior staff and impact patient care

Qualifications

Bachelor level or higher in a lab science field from an accredited institution.
HT/HTL (ASCP) certification required.
2 years histology/anatomic pathology experience required, more with preferred background.

Responsibilities

Manage validations and enhancement of clinical tests in Histology, ISH, IHC, and Image Analysis.
Provide insight on assay design and maintain assays/instrumentation with AP department.
Assist with IQ/OQ/PQ per SOP and regulatory compliance.
Train staff and provide support to maintain routine operation.
Prepare validation summaries and ensure documentation per CAP/CLIA.

Skills

Histology

IHC

ISH

Image Analysis

Regulatory knowledge

Education

B.S. in chemical/biological/clinical laboratory science or medical technology

ASCP HT/HTL

Equivalent education 60 semester hours with 24 in bio/chem

Tools

Staining platforms

Job description

The role requires a solid lab science background, ASCP HT/HTL credentials, and 2 years of Histology experience, with opportunities to mentor junior staff and impact patient care

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