Scientist

at  GAP Solutions Inc

Provide services as a Scientist in support of the overall functions of the Senior Analytical Development Scientist in the Immunoassay Group. Will work in the Analytical Development group of the Vaccine Production Program (VPP) / Vaccine Research Center (VRC). within the National Institute of Allergy and Infectious Diseases (NIAID).

BASIC QUALIFICATIONS:

• PhD in biochemistry or an immunologist or related discipline with relevant years of experiences and capabilities.
• 10+ years in a related scientific discipline.
• Have in-depth institutional knowledge on clinical development products including all VPP monoclonal antibodies, recombinant proteins for vaccine candidates, including virus-like particles (VLP) and nanoparticles.
• Demonstrated analytical capabilities with techniques used in the analytical development in support of process and product development may include: Binding assays, Cell based assay, Residual immunoassays.
• A thorough understanding of protein analysis with experience in quantitative and qualitative protein analysis for assay development is required.
• Knowledge of the requirements and experience developing, qualifying and/or validating assays for cGMP products and managing method transfers between laboratories is highly desirable.
• The candidate will be involved in developing, characterizing, and transferring assays to the VRC pilot plant’s QC group for product release.
• Demonstrate the ability to work well within a team, the candidate must be a team player who can effectively work with other research, development, and cGMP personnel.

MINIMUM QUALIFICATIONS:

• 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 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.

• Assist the Federal Task Leader (FTL) to ensure the scientific rigor for immunoassay and broader scope of analytical assays.
• Collaborate with scientists in other departments from upstream, downstream and formulation development groups to provide assay support and optimize analytical assays.
• Author experimental plan (EP), lead and carry out new method development and characterization plan, trouble shoot, execute, and coordinate experiments that will lead to conclusions.
• Write technical reports and manuscripts with scientific rigor. Write one or more per year reporting new scientific advancement.
• Identify scientific gaps in current project and provide recommendations to the FTL for correction.
• Work independently within project teams to design, develop and optimize analytical assays and provide assay support for clinical trial vaccine candidates. Write SOPs and publications if method is deemed innovative by FTL.
• Reports to FTL weekly with progress and data packages. Bring assessment with suggestions, and target timelines. Thoroughly and accurately communicate scientific rational and findings to VPP leadership.
• Design and execution of experiments for the development of analytical assays required for product development and clinical manufacturing.
• Lead experimental design, carry out experiments, trouble shoot methods or help with trouble shooting material issues with solid methods.
• Write and review technical protocols and reports documenting analytical development studies pertaining to his/her work and the work of the group.