Nextonic Solutions is seeking a highly ambitious, adaptable, structured, and detail-oriented Biologist to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Vaccine Immunology Program (VIP).
- Utilize established SOP’s to execute testing for clinical research trials.
- Document testing parameters according to GCLP 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.
Experience Required / Requirements
- Bachelor’s degree or higher in a biology-related discipline.
- Minimum of 2 years of experience in the pharmaceutical, vaccine, biologics, or similar industry is required.
- Experience in aspects of clinical trial implementation and testing is preferred.
- Familiarity with immunoassays, including pharmacokinetics, anti-drug antibody, 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 with automated systems such as liquid handlers and high-throughput robotic instruments is preferred.
- Data analysis and use of analytical software.
- Proficient in Microsoft work, PowerPoint, Prism and Excel.