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Biologist - Bethesda, United States - RJ IT Solutions
Description
RJIT Solutions is an information technology and bioscience company that specializes in providing innovative solutions in biomedical research and data science. We serve healthcare organizations by leveraging the expertise of our team in science, software engineering, program/project management. Our commitment to excellence has made us a trusted partner of top research organizations, including multiple institutes at the National Institutes of Health (NIH). At RJIT Solutions, we combine the agility of a small business with the comprehensive capabilities of a large organization to accelerate research and enhance decision-making processes in healthcare and research sectors. As part of our unrelenting focus on quality and compliance, RJIT Solutions' delivery is based on Certified Matured Processes including CMMI L3 SVC, ISO 20000, ISO 27001, and ISO 9001 quality processes.
Technical Requirements: Biologist
• 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.
Other Requirements:
• Telework may be authorized if approved by the Task Leader, COR, and the Contracting Officer.
Specific Qualifications:
• Master's degree in a biology-related discipline preferred.
• Minimum of 4 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, immunogenicity, and neutralization assays.
• Experience in a GLP, GCLP, cGMP, laboratory.
• Experience in a diverse set of clinical research techniques such as;
o Immunoassay methodology – ELISA, ECLIA, ADA, SMC
o Pseudovirus neutralization assay
o ELISpot Assays
o Cell culture and other cell-based assays
• Experience with automated systems such as liquid handlers and high-throughput robotic instruments is preferred.
• Ability to work in a dynamic fast-paced environment and to adapt quickly to changing project priorities.
• Experience and ability to communicate scientific findings through different mediums including posters, online presentations, and in-person presentations.
• Strong communication skills to effectively collaborate with cross-functioning teams.
• Self-motivated and can work independently.
• Attention to detail for high quality outcomes.
• High organizational and communication skills.
• Data analysis and use of analytical software.
• Proficient in Microsoft work, PowerPoint, Prism and Excel.
