Biologist - Gaithersburg, United States - GAP Solutions, Inc.

GAP Solutions, Inc.
GAP Solutions, Inc.
Verified Company
Gaithersburg, United States

3 weeks ago

Mark Lane

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Mark Lane

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Description

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.
  • 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 biologyrelated 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, antidrug antibody, and neutralization assays.
  • Data analysis and use of analytical software.
  • Proficient in Microsoft work, PowerPoint, Prism and Excel.

Minimum Qualifications:


  • Experience performing IQ-OQPQ 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 crossfunctioning teams.
  • Selfmotivated 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 nontechnical and technical staff.
  • Detailoriented 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.
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