Scientist I/II, Immunology/Virology/Serology

Scientist I/II, Immunology/Virology/Serology

Job ID: req3861
Employee Type: exempt full-time
Division: Vaccine, Immunity and Cancer
Facility: Frederick: ATRF
Location: USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION

The Vaccine, Immunity and Cancer Directorate investigates immune responses to vaccines in preclinical and clinical studies, with a focus on HPV and more recently on SARS-CoV-2. As part of a large effort to combat the current SARS-CoV-2 pandemic, the National Cancer Institute (NCI) is collaborating with the National Institute of Allergy and Infectious Disease (NIAID), the Centers for Diseases Control and Prevention (CDC), the Food and Drug Administration (FDA), the Frederick National Laboratory (FNL) and other stakeholders to develop assays with the highest reproducibility, sensitivity, and specificity for evaluation of immune responses against this new virus. To address gaps and unmet needs in serology assay development and standardization and to gain a solid fundamental knowledge of the immune response to SARS-CoV-2 and underlying mechanisms of protection against infection, NCI has established the Serological Sciences Network (SeroNet), which includes the Frederick National Laboratory (FNL) Serology Lab, leveraging the vast expertise and excellence in HPV serology at the FNL.

KEY ROLES/RESPONSIBILITIES

The Scientist will be responsible for leading assay development and validation projects as well as studies evaluating immune responses to infection, vaccines and cancer.

• Strong scientific background on immunology, virology and serology
• Serve as scientific/technical lead for the assigned projects
• Serve as scientific/technical lead for assay development, assay validation and high throughput testing
• Plan and work independently with minimal supervision
• Perform technical development and qualification /validation of various immunological assays including cell-based viral neutralization assays, ELISAs, multiplex assays
• Assay Development (including experimental design and troubleshooting), optimization and validation of immune assays
• Previous experience in conducting assay validation, including protocol and report writing
• Design, implement, execute assigned projects with minimal supervision
• Prepare documentation associated with project/objectives including technical reports, SOPs, project specific protocols and reports
• Prepare manuscripts and scientific presentations
• Ensure laboratory procedures and testing is compliant with internal requirements and quality system
• Work with automated systems, such as robotics, system integration and software programming
• Oversight of critical reagent and assays standard production
• Oversight of equipment qualification and validation relevant to the various assays
• Analyze data and present findings at meetings

BASIC QUALIFICATIONS

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

• Possession of a PhD degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field. Foreign degrees must be evaluated for U.S. equivalency
• In addition to the education requirement:
  • Scientist I - No experience required beyond Doctoral degree
  • Scientist II - Minimum two (2) years of relevant experience in Biology, Immunology, Microbiology, Molecular biology or related field in GCLP Clinical Immunology Lab or other related areas in Biotech or Pharma Industry setting
• Extensive experience in ELISA, viral neutralization assays and mammalian cell culture required
• Experience in development, qualification & validation of relevant immune assays
• Experience in conducting assay validation, including protocol and report writing.
• Understanding of GCLP requirements and other FDA regulatory requirements for immunological testing
• Team player with outstanding oral/written communication skills and ability to multi-task
• Ability to work independently on projects with minimal supervision
• Strong Computer skills and experience with relevant software such as Softmax, Excel, PowerPoint, ability to analyze data using statistical tools (e.g. JMP, Prism)
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Regulatory knowledge pertinent to standards GCLP, CLIA or FDA guidelines for clinical assays
• Familiarity with diagnostics and clinical trials
• Experience with LIMS and Robotics
• Experience compiling and analyzing large data sets
• Project Management Professional (PMP) certification
• In‐depth understanding of immunology, immune assays, diagnostics, vaccines and clinical research
• Excellent communication skills (written and oral)
• Ability to work effectively in a team‐oriented environment
• Ability to identify and solve complex problem
• Strong organizational and multitasking skills
• Strong Computer skills and experience with relevant software such as Softmax, Excel, PowerPoint, ability to analyze data using statistical tools (e.g. JMP, Prism)

JOB HAZARDS

• Work may involve the use of potentially hazardous chemical or biological materials or may be located in areas where such materials are used

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

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