Biologist

GAP Solutions - Gaithersburg, MD

Gaithersburg, MD

Administrative and Support Services

About the position

Provide services as a Biologist in support of the overall functions of the Vaccine Research Center (VRC), Vaccine Immunology Program (VIP) within the National Institute of Allergy and Infectious Diseases (NIAID).

Responsibilities

• Utilize established SOPs to execute testing for clinical research trials.
• Document testing parameters according to GCLP and GDP guidelines and analyze testing results.
• Write and revise SOPs, evaluation and developments reports and analytical plans.
• Develop testing activities and method protocols with senior staff.
• Maintain cell lines and reagents necessary for assays.
• Develop, optimize, and execute qualification and validation of methods.
• Improve existing methodology and generation of novel research experiments while maintaining detailed documentation as per the SOPs.
• Perform necessary QA/QC activities as per laboratory guidelines and the quality management plan.
• Troubleshoot assays and adjust scientific methodology to correct problems or deficiencies in a research project or experiment.
• Maintain accurate laboratory records to ensure proper retention of scientific data.
• Maintain laboratory supplies inventories.
• Attend staff meetings and regularly present experimental data.
• Work collaboratively and independently as needed to adhere to project timelines.
• Work with dry ice, freezers, and liquid nitrogen tanks to store clinical samples, and perform clinical testing in a BSL-2 environment while always wearing appropriate PPE.
• Present scientific data and findings at lab-wide, VRC-wide, and NIH-wide meetings.

Requirements

• Bachelor's degree or higher in a biology-related discipline.
• Minimum of 4 years of experience in the pharmaceutical, vaccine, biologics, or similar industry is required.
• Familiarity with immunoassays, including pharmacokinetics, anti-drug antibody, immunogenicity, and neutralization assays.
• Experience in a GLP, GCLP, cGMP, laboratory.
• Experience in a diverse set of clinical research techniques such as immunoassay methodology - ELISA, ECLIA, ADA, SMC, pseudovirus neutralization assay, ELISpot Assays, cell culture and other cell-based assays.
• Experience and ability to communicate scientific findings through different mediums including posters, online presentations, and in-person presentations.
• Data analysis and use of analytical software.
• Proficient in Microsoft Word, PowerPoint, Prism, and Excel.

Nice-to-haves

• Master's degree in a biology-related discipline preferred.
• Experience in aspects of clinical trial implementation and testing is preferred.
• Experience with automated systems such as liquid handlers and high-throughput robotic instruments is preferred.
• Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects.
• Self-motivated and can work independently.
• Ability to work in a dynamic fast-paced environment and to adapt quickly to changing project priorities.