Development Associate II - VICD

Initial Therapeutics, Inc.; Frederick (MD); On-site; USD 64,000 - 91,000; Full time

Job summary

Leidos Biomedical Research, Inc. invites applications for a Development Associate II in the Vaccine, Immunity and Cancer Directorate (VICD) at Frederick. The role focuses on advancing immune monitoring, biomarker and assay development in a collaborative, state-of-the-art lab.

The position involves independent experimental design, implementation of novel assays, data analysis, and preparation of publications, with opportunities to contribute to translational research and clinical studies.

Qualifications

• Master's degree in Biology, Immunology, Microbiology, Molecular biology or related field (CHEA accredited) or six years relevant experience in lieu of degree.
• Minimum of two years of experience in a GCLP Clinical Immunology Lab or related Biotech/Pharma setting.
• 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 environments, familiar with LIMS, good documentation practices, SOP writing.
• Strong communication skills and ability to multi-task.
• Ability to work independently with minimal supervision.
• Proficient with software such as Softmax, Excel, PowerPoint, R Script, Python; ability to analyze data.

Responsibilities

• Develop, optimize, qualify/validate, and implement novel immune, cell-based, and molecular assays with minimal supervision.
• Design and execute experiments for assay platforms (ELISA, multiplex, qPCR, sequencing, etc.).
• Carry out experimental design and troubleshooting with guidance from manager.
• Evaluate and integrate novel assay technologies and instrumentation to improve performance.
• Prepare manuscripts, reports, and scientific presentations.
• Ensure procedures and testing comply with internal quality systems (GCLP).
• Assist in data analysis, compilation, and presenting findings at meetings.
• Maintain inventory and QC/QA procedures for studies.
• Write SOPs and protocols for publications and internal use.

Skills

ELISA

Multiplex immunoassays

Virus neutralization assays

Mammalian cell culture

Flow cytometry

qPCR

Molecular biology assays

Transcriptomics

Data analysis

Scientific communication

Education

Master's degree in Biology, Immunology, Microbiology, Molecular biology or related field

Six years of relevant experience in lieu of degree

Tools

Softmax

Excel

PowerPoint

R Script

Python

Job description

Development Associate II - VICD

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 theFrederick National Laboratory investigates immune responses to vaccines inpreclinical and clinical studies. The Frederick National Laboratory (FNL) incollaboration with other stakeholders develop assays with the highestreproducibility, sensitivity, and specificity for evaluation of immuneresponses against viruses and vaccines in clinical trials.

KEY ROLES/RESPONSIBILITIES

The Vaccine, Immunityand Cancer Directorate (VICD) is recruiting for a highly motivated andinnovative Development Associate II, to join a multidisciplinary team advancingcutting-edge immune monitoring, biomarker, vaccine, and cancer research. Thesuccessful candidate will work in a state-of-the-art laboratory environmentequipped with advanced technologies for immune, cell-based, and molecular assaydevelopment and testing. This position provides an opportunity to contribute tothe development, optimization, qualification, validation, and implementation ofnovel assays and emerging technologies supporting translational research,clinical studies, vaccines, immunotherapies, and cancer research.

Thisposition reports to the Scientific Manager and under the direction and guidanceof 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
• Performother 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 inBiology, 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
• Experienceworking in GCLP/GxP laboratory environment, familiar with LIMS, gooddocumentation practices, SOP writing
• Team playerwith outstanding oral/written communication skills and ability tomulti-task
• Ability towork independently on projects with minimal supervision
• StrongComputer skills and experience with relevant software such as Softmax,Excel, PowerPoint, R Script, Python, etc. and ability to analyze datausing statistical tools
• Scientificcompetency in a field relevant and related to cancer research
• Mustbe 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 inGCLP 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 clinicaltrials
• 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 largedata sets
• Project Management Professional (PMP)certification
• Regulatory knowledge pertinent tostandards GCLP, CLIA or FDA guidelines for clinical assays
• Experiencemanaging clinical immunological studies and consortia activities
• Experience working internationally in theareas 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