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).
Responsibilities
- 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.