Assay Development Specialist - Histology

NeoGenomics Laboratories; Ramsey (NJ); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

Competitive benefits

401k match

Employee Stock Purchase Program

Tuition reimbursement

Paid time off

Job summary

A leading laboratory services provider in New Jersey seeks an Assay Development Specialist I to manage clinical test validations and enhancements in Histology. This role involves technical responsibilities, requiring strong laboratory techniques and interpersonal skills. Candidates must possess a Bachelor’s degree in relevant sciences, at least 2 years of experience in Histology, and certifications such as HT or HTL (ASCP). The position offers a dynamic work environment with numerous learning opportunities.

Qualifications

• Bachelor's degree or higher in relevant scientific fields.
• 2 years of experience in Histology or Anatomic Pathology.
• HT or HTL (ASCP) certification required.
• Equivalent education with specified biology/chemistry coursework accepted.

Responsibilities

• Manage validations and enhancement of clinical tests.
• Prepare validation summaries for completed validations.
• Assist in maintaining compliance with CAP/CLIA regulations.
• Troubleshoot test performance and instrumentation issues.
• Perform staining for assay validation.
• Support stimulation, staining, and image analysis workflows as assigned.
• Mentor junior staff and coordinate with other departments.

Skills

Laboratory techniques

Interpersonal skills

Regulatory knowledge

Assay validation

Reagent preparation

Staining methods

Education

Bachelor of Science in chemical, biological or clinical laboratory science

Associate of Science in laboratory science

Associate degree in laboratory science

Job description

Overview

Are you motivated to participate in a dynamic, multi-tasking environment? Do you want to join a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to dive deeper into this opportunity. We believe in career development and empowering our employees. Not only do we provide career coaches internally, but we offer many training opportunities to expand your knowledge base! We have highly competitive benefits with a variety of HMO and PPO options. We have company 401k match along with an Employee Stock Purchase Program. We have tuition reimbursement, leadership development, and even start employees off with 16 days of paid time off plus holidays. We offer wellness courses and have highly engaged employee resource groups. Come join the Neo team and be part of our amazing World Class Culture! NeoGenomics is looking for a n Assay Development Specialist for our Histology department in Ramsey, NJ who wants to continue to learn in order to allow our company to grow. Shift: Monday-Friday, 9:00am-5:30pm (subject to change based on business needs)

Position Summary

The Assay Development Specialist I, Anatomic Pathology manages the validations and enhancement of clinical tests and services in the following areas: Histology, ISH, IHC, and Image Analysis at the local site level. The Specialist provides insight to assay design, performs validations, and works cohesively with the local AP department to maintain assays and instrumentation for the department. This is a technical role that reports to the Assay Development Manager for Anatomic Pathology. This role requires a combined set of strong technical and interpersonal skills. The Assay Development Specialist I must have high understanding of laboratory techniques and clinical lab practices. The Assay Development Specialist I has ongoing opportunities to mentor junior members of the department and interact with numerous levels of staff in other departments.

Core Responsibilities

• Demonstrate initiative in making suggestions to improve efficiency throughout the AP lab section
• Prepare validation summary for each completed validation
• Assist in maintaining documentation and slides per CAP/CLIA regulations
• Basic knowledge of regulatory regulations
• Assist in troubleshooting of test performance and instrumentation issues
• Performs the bi-annual instrument and/or assay correlations as assigned
• Assist in the IQ/OQ/PQ process for all instrumentation per SOP
• Assist in maintaining and enhancing existing assays as assigned
• Perform staining for assay validation per SOP or established validation plan
• Proficient with department staining and scanning platforms and programs
• Assist in specimen procurement for validation as assigned
• Prepare and update internal document for review
• Assist in coordinating instrument maintenance and service
• Assist with internal PT and AA as assigned
• Proficient in reagent preparation
• Basic knowledge of antibody and IHC staining methods
• Assist in training laboratory staff as assigned
• Provide support to laboratory staff and management to maintain routine operation

Experience, Education and Qualifications

• Bachelor of Science in chemical, biological, or clinical laboratory science or medical technology ( Histotechnology Program) from an accredited institution - OR -
• Associate of Science in a laboratory science, or medical laboratory technology from an accredited institution - OR -
• Equivalent education of 60 semester hours with 24 sem ester hours in biological and chemical science courses
• 2 years of experience in Histology/Anatomic Pathology required, 4 total years of experience preferred
• HT or HTL (ASCP) required