Biologist

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:

• Support the automated clinical testing team by authoring standard operating procedures, clinical trial plans and reports, and related testing documentation.

• Develop and program process flows on liquid handlers such as the Biomek i7 and Hamilton Vantage.

• Maintain program readiness by coordinating program development, testing schedules, critical reagent inventories, and test record preparation.

• Monitor and assess the status of Vaccine Immunology Program projects through study lifecycle, including deadlines and other benchmarks to ensure that VRC activities are meeting stipulated obligations.

• Apply technical knowledge to guide project decisions.

• Respond to requests from senior staff to accommodate changes in testing parameters, study designs, and previously established automation programs.

• Liaise with the core elements of the Vaccine Immunology Program analytical clinical testing laboratories for the provision of resources: funding, analytical reagents, method optimization and novel assay development suitable to vaccines and biologics.

• Serve as a representative of the Vaccine Immunology Program on project teams clinical trial discussions for the VRC.

• Anticipate major problems and recognizes future program needs to accomplish clinical trial deliverables.

Basic Qualifications:

• Master's degree or higher in a biology-related discipline.

• Previous experience with automations or programming equipment in a laboratory testing environment, namely of automated liquid handlers.

• Experience in authoring SOPs and technical documentation.

• Familiarity with immunoassays, including immunogenicity, anti-drug antibody, and neutralization assays .

• Data analysis and use of analytical software.

• Proficient in Microsoft work, PowerPoint, Prism and Excel.

Minimum Qualifications:

• Experience performing IQ-OQ-PQ of computer systems is a plus.

• Experience managing aspects of clinical trial implementation and testing is a plus.

• 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.

• 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

*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 ~~~ . 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.

Requisition ID: 6803