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Assay Development Specialist - Anatomic Pathology
Ref No.: 20-00519
Category: Biotechnology
Location: Ft Myers, Florida
The Assay Development Specialist, Anatomic Pathology is the primary manager of validation and enhancement of clinical tests and services in the following areas: Histology, ISH, IHC, and Image Analysis. The Specialist provides insight to assay design, drives the validation process, and initiates communication with other Company departments to create efficient and effective commercial launches.
  • Assist with product development concepts and technical design for new and enhanced assays and services in the clinical AP laboratory
  • Lead development of assigned new assays
  • Contribute to design and scheduling of validation study plans
  • Train validation staff and oversee study execution
  • Anticipate and troubleshoot test performance, workflow, and instrumentation issues
  • Prepare high-quality and timely reports to document development activities and assay performance
  • Oversee transfer to clinical production including lab staff training as needed
  • Prepares validation summary for each completed validation
  • Maintains all documentation and slides per CAP/CLIA regulations
  • Serve as liaison to IT, Client Services, Billing, Marketing, Accessioning, Pharma Services, and other departments as needed for launch and initial testing period of new assays

Qualifications:
  • B.S or M.S. in a life or physical science with related experience.
  • Five or more years related laboratory experience.
  • HT (ASCP) or HTL (ASCP) required within 6 months of assuming the position.
  • Solid understanding of laboratory techniques
  • Ability to synthesize complex directions into scientific project plans
  • Detail-oriented with ability to capture and record complex scientific data accurately and reliably
  • Excellent written and verbal presentation skills and the ability to use software tools to produce effective presentations
  • Ability to problem solve independently and escalate problems appropriately in a timely manner
  • Ability to work independently and within a team environment
  • Must be able to work in a fast paced, multi-tasking environment and maintain production and quality standards