Demo

GCLP Research Associate II

BioSpace
Frederick, MD Full Time
POSTED ON 2/9/2025
AVAILABLE BEFORE 3/11/2025
Job ID: req4214

Employee Type: exempt full-time

Division: Vaccine, Immunity and Cancer

Facility: Frederick: ATRF

Location: 8560 Progress Dr, Frederick, MD 21701 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 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.

The Vaccine, Immunity, and Cancer Directorate (VICD) at the Frederick National Laboratory has a primary mission to provide scientific leadership and laboratory infrastructure to study immune responses to Human Papillomavirus (HPV) vaccines and other cancer preventive strategies in the context of clinical and pre-clinical studies. More recently, VICD is also leading initiatives on SARS-CoV-2 infection and vaccines.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.

Key Roles/Responsibilities

We are seeking an individual with a strong background in molecular biology and immunology to work at the HPV Serology Laboratory to work on projects in the area of vaccine immunogenicity. The aim of this project is to generate standardized sets of reagents, develop assays for assessment of antibody responses to HPV and conduct high throughput immunogenicity testing of vaccines in the context of clinical trials. This position is not eligible for telework and is a 100% onsite position.

Responsibilities Include, But Are Not Limited To, The Following

  • Perform tissue culture and immunological/virological techniques, including aseptic techniques, cell line maintenance, production of plasmids and virus-like particles.
  • Oversee serology projects from conception to execution.
  • Responsible for sample management in LIMS.
  • Optimize and validate procedures and methodologies for assessment of immune responses to infection and vaccines.
  • Perform immunoassays, testing of large number of samples from clinical studies.
  • Implement protocols, as well as troubleshoot assays and experiments independently.
  • Evaluate, analyze and compile data, maintain databases.
  • Responsible for routine QC/QA procedures, ordering supplies, and maintaining equipment and inventories.
  • Prepare reports, present data and participate in report and proposal preparation.
  • Lead SOP development or review and modify SOPs in Master Control and perform validations on processes as required.
  • Perform laboratory processes in LIMS.
  • Maintain equipment, supply inventory, assist in routine laboratory operation matters.
  • Able to independently troubleshoot assays, processes, laboratory matters and bring to manager’s attention.
  • Remain current on literature and relevant laboratory techniques.
  • Other duties as assigned.


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 in immunology, vaccinology, or molecular biology from an accredited college/university according to the Council for Higher Education Accreditation (CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
  • In addition to the education requirement, a minimum of five (5) years of progressively responsible experience.
  • Detailed knowledge of vaccines, immunology, and virology.
  • Expertise in tissue culture and immunological/virological techniques, including aseptic techniques, cell line maintenance, production of plasmids and virus-like particles, western-blot, ELISA, Luminex assays, flow cytometry, virus neutralization assays and PCR.
  • Ability to obtain and maintain a security clearance.


Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

  • MS or Ph.D. in immunology, vaccinology, virology or molecular biology.
  • Experience managing personnel and lab operation.
  • Experience in immune assay (ELISA, multiplex assays) development and validation under GCLP or GLP environment.
  • Experience handling large data sets, statistics, software tools (Word, Excel, PowerPoint)
  • Experience in laboratories operating under GCLP/GMP/GLP/CLIA.
  • Experience using robotics.
  • Experience with electronic documentation systems and LIMS.


JOB HAZARDS

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


Commitment to Diversity

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, 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.

68,600.00 - 117,875.00

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.

#readytowork

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

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