Circulating Tumor Cell Methods Developer

The Clinical PD Biomarkers Program is responsible for identification of pharmacodynamic biomarkers of response to new targeted agents entering clinical trials in the Developmental Therapeutics Program of the National Cancer Institute. The scope of work includes assay design, development, validation, fitness for purpose testing, transfer of assays to clinical laboratories, and clinical specimen analysis when required. The program uses biomarker assays that meet or exceed clinical assay performance standards to provide mechanistic understanding of experimental and investigational anti-cancer agents and their optimal use that dovetails with other clinical applications, including distinct molecular signatures for cancer, refined molecular assays, and state-of-the-art imaging techniques. The program operates a number of advanced, specialized instrumentation platforms for image analysis of tumor biopsies, circulating tumor cells, and activated T cells for measuring drug biomarker responses in patients enrolled in clinical trials and in relevant preclinical models.

KEY ROLES/RESPONSIBILITIES

The Research Associate III will:

• Develop and validate new methods for the isolation, enumeration and biomarker analysis of circulating tumor cells (CTCs)
• Develop biomarker assays to evaluate circulating tumor cells in liquid specimens from cancer patients and from mice harboring patient-derived tumors using modern technology platforms
• Develop and implement analyses of CTCs using multiplex immunofluorescence assays using confocal microscopy, whole slide imaging or imaging cytometry in support of clinical studies and initiatives
• Perform both routine and experimental analysis of human and animal blood samples and tumor cell lines at the level of individual cells
• Perform data analysis of results from immunofluorescence assay studies on preclinical and clinical samples
• Design, test, and write detailed technical SOPs for imaging and CTC analysis for assay transfer to external labs
• Generate materials and data necessary to support the primary experimental objectives of the program
• Maintain instrumentation, computer databases, and assure regulatory and safety compliance within the laboratory
• Perform extensive benchwork with advanced automated instrumentation

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) or four (4) years equivalent experience in the appropriate field in lieu of degree.
• Foreign degrees must be evaluated for U.S. equivalency
• Candidate must have completed laboratory science courses in two or more of the following subjects: histology; chemistry; biochemistry; immunology; pharmacology; cell biology; hematology
• In addition to educational requirements, a minimum of eight (8) years of related biomedical experience
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Four (4) or more years relevant experience in processing and analysis of blood specimens from pre-clinical and clinical models
• Experience with the isolation and analysis of CTCs from clinical or preclinical specimens
• Experience in cell-based analysis and assay development
• Day-to-day experience in managing laboratory infrastructure in a GxP environment
• Quantitative laboratory work experience one of the following areas: biochemistry, cell biology, chemistry, biotechnology, and/or histopathology

EXPECTED COMPETENCIES

• Ability to develop, modify methods and techniques independently, under supervision of a lead scientist
• Ability to maintain precise records. Must be able to provide accurate scientific reports including details of experimental procedures, results and conclusions to supervisor
• Demonstrated expertise in aseptic cell culture and maintenance of multiple different cell lines without contamination
• Demonstrated expertise in drug and chemical preparation
• Hands on experience in two or more basic cell biology techniques is essential: antibody-based assays, immunofluorescence assays, cell lysate extraction, western-blotting, 96-well plate ELISAs.
• Hands on experience with one or more of the following cell analysis techniques: immunofluorescence; confocal microscopy; imaging flow cytometry such as Amnis; CTC analyzers such as Cell Search or ApoStream; Incell analyzers; fluorescence microscopy; protein concentration determination assays, single cell analysis, cellular imaging
• Experience performing In vitro cell line testing using multiple test agents and drug combinations of interest to determine drug dose responses, biomarker feasibility, timing of marker activation.
• Ability to recognize when scientific findings deviated from expected results and how to distinguish discoveries from suspect results
• Ability to perform experiments in compliance with/under control of an SOP
• Ability to manage work on multiple projects simultaneously, and to adapt to frequent changes in project priorities
• Ability to quickly master new and novel measurement technologies and instrumentation
• Excellent written and spoken English language and computer skills (essential)
• Proficiency with Microsoft Office software (Outlook, Excel, Word, and PowerPoint)

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)