Development Associate II - VICD

BioSpace; Frederick (MD); On-site; USD 64,000 - 91,000; Full time

Benefits offered by this job

Health and Wellness programs

Income Protection

Paid Leave

Retirement

Job summary

The Frederick National Laboratory for Cancer Research, operated by Leidos Biomedical Research, Inc., is seeking a Development Associate II to advance immune, cell-based, and molecular assay development in a cutting-edge lab.

You will design, optimize and validate assays, contribute to translational research, and present findings while adhering to GCLP standards and quality systems. Collaboration across disciplines is essential for success.

Qualifications

• Master’s degree in Biology, Immunology, Microbiology, Molecular biology or related field with CHEA or six years experience in lieu of degree.
• Experience in ELISA, viral neutralization assays and mammalian cell culture.
• Experience in development, qualification & validation of immune and molecular biology assays.
• Experience in GCLP/GxP lab environments and SOP writing.

Responsibilities

• Develop, optimize, qualify/validate, and implement novel immune, cell-based, and molecular assays with minimal supervision
• Design and execute experiments supporting assay platforms including ELISA, viral neutralization,flow cytometry, and molecular assays
• Prepare manuscripts, reports and scientific presentations
• Ensure lab procedures meet GCLP/QMS requirements
• Assist in data analysis and presenting findings in meetings
• Write SOPs and protocols for publications

Skills

Immunology expertise

Molecular biology

Cell culture

Data analysis (R/Python)

Team collaboration

GCLP/GxP knowledge

Security clearance ability

Education

Master’s degree in Biology/Immunology/Molecular biology

Tools

LIMS

Robotics

Softmax

Excel

PowerPoint

JMP

Prism

R Script

Python

Job description

Job ID: req4682

Employee Type: exempt full-time

Division: Vaccine, Immunity and Cancer Directorate

Facility: Frederick: ATRF

Location: 8560 Progress Dr, Frederick, MD 21701 USA

The Frederick National Laboratory is 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 (VICD) at the Frederick National Laboratory investigates immune responses to vaccines in preclinical and clinical studies. The Frederick National Laboratory (FNL) in collaboration with other stakeholders develop assays with the highest reproducibility, sensitivity, and specificity for evaluation of immune responses against viruses and vaccines in clinical trials.

Key Roles and Responsibilities

The Vaccine, Immunity and Cancer Directorate (VICD) is recruiting for a highly motivated and innovative Development Associate II, to join a multidisciplinary team advancing cutting-edge immune monitoring, biomarker, vaccine, and cancer research. The successful candidate will work in a state-of-the-art laboratory environment equipped with advanced technologies for immune, cell-based, and molecular assay development and testing. This position provides an opportunity to contribute to the development, optimization, qualification, validation, and implementation of novel assays and emerging technologies supporting translational research, clinical studies, vaccines, immunotherapies, and cancer research.

This Position Reports To The Scientific Manager And Under The Direction And Guidance Of The Manager, The Following Tasks Will Be Performed

• Develop, optimize, qualify/validate, and implement novel immune, cell-based, and molecular assays with minimal supervision
• Design and execute experiments supporting innovative assay platforms, including technologies such as:
• ELISA and multiplex immunoassays
• Viral neutralization and functional antibody assays
• Cell-based functional and reporter assays
• Mammalian cell culture
• Flow cytometry and immune-cell phenotyping
• Cytokine and immune-response assays
• PCR/qPCR and other nucleic-acid-based assays
• Molecular and biomarker assays
• Transcriptomics and sequencing
• Emerging high-throughput and multiplex technologies
• Carry out experimental design and troubleshooting independently, in consultation with manager
• Evaluate and integrate novel assay technologies, advanced instrumentation, automation, robotics, and laboratory software to improve assay performance, throughput, reproducibility, and data quality
• Prepare manuscripts, reports and scientific presentations
• Ensure laboratory procedures and testing are compliant with internal requirements, such as GCLP and quality system, as necessary
• Assist in evaluating, analyzing, compiling data, and present findings at meetings
• Responsible for routine QC/QA procedures, ordering supplies, and maintaining inventory for the studies
• Perform literatures searches and reviews that will contribute to the development of new assays
• Write SOPs, protocols, manuscripts for publications
• Perform other duties as assigned

Basic Qualifications

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

• Master's degree in Biology, Immunology, Microbiology, Molecular biology or related field from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or six (6) years relevant experience in lieu of degree.
• In addition to the education requirement, a minimum of two years of experience in a GCLP Clinical Immunology Lab or other related areas in a Biotech or Pharma Industry setting
• Experience in ELISA, viral neutralization assays and mammalian cell culture
• Experience in development, qualification & validation of immune and molecular biology assays
• Experience working in GCLP/GxP laboratory environment, familiar with LIMS, good documentation practices, SOP writing
• 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, R Script, Python, etc. and ability to analyze data using statistical tools
• Scientific competency in a field relevant and related to cancer research
• Must be able to obtain and maintain a security clearance

Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

• Ph.D. in Biology, Immunology, Microbiology, Molecular biology or related field in GCLP Clinical Immunology Lab or other related areas in Biotech or Pharma Industry setting
• A minimum of five years of related experience
• Familiarity with diagnostics and clinical trials
• Understanding of GCLP requirements and other FDA regulatory requirements for immunological testing
• Experience in conducting assay validation, including protocol and report writing
• Experience with LIMS and robotics
• Experience compiling and analyzing large data sets
• Project Management Professional (PMP) certification
• Regulatory knowledge pertinent to standards GCLP, CLIA or FDA guidelines for clinical assays
• Experience managing clinical immunological studies and consortia activities
• Experience working internationally in the areas of assay standardization

EXPECTED COMPETENCIES

• Understanding of immunology, immune assays, diagnostics, vaccines and clinical research
• Excellent communication skills (written and oral)
• Ability to work effectively in a matrix and team‑oriented environment
• Ability to identify and solve complex problems
• 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

• This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations

Commitment to Non-Discrimination

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

Pay And Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

63,500.00 - 90,950.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions