Position Objective: 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).
Duties and 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.
Basic Qualifications: - 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:
o Immunoassay methodology - ELISA, ECLIA, ADA, SMC
o Pseudovirus neutralization assay
o ELISpot Assays
o 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 work, PowerPoint, Prism and Excel.
Minimum Qualifications: - 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.
*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.
GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.
This position is contingent upon contract award.
