Scientist (Cell Line Engineering)
GAP Solutions Inc
**Position Objective:** Provide services as a Scientist in support of the overall functions of the Vaccine Research Center (VRC), Vaccine Production Program (VPP) within the National Institute of Allergy and Infectious Diseases (NIAID).
**Duties and Responsibilities:**
+ Plan and execute the generation of stable cell lines for preclinical and clinical material production to advance candidates including monoclonal antibodies, recombinant proteins, and virus-like particles.
+ Gene synthesis including oligo synthesis, plasmid design, and construction.
+ Manage timelines and experimental plans for multiple projects simultaneously and regularly review records of tasks performed by other team members.
+ Independently execute and/or manage all steps of the process including plasmid construction, stable pool generation, single cell cloning, and top clone selection.
+ Draft and verify data for CMC sections of pre-IND and IND documents to ensure successful registration of candidates.
+ Design, perform, and troubleshoot experiments and analyze data for both development and deliverable projects.
+ Identify, propose, and execute process and procedural changes to improve performance, robustness, productivity, and efficiency by reviewing recent literature and new technologies.
+ Oversee maintenance and support for one or more pieces of laboratory instrumentation.
+ Generate, maintain, and review accurate daily records of experiments and results in a laboratory notebook.
+ Prepare and review experimental plans, proposals, reports, SOPs, and production records.
**Qualifications**
**Basic Qualifications:**
+ **Ph.D. in Biological Sciences with a minimum of 2 years of experience in an industrial setting focused on the development of stable cell lines for vaccine and biotherapeutic candidates**
+ **Extensive hands-on experience with aseptic technique and mammalian cell culture for the purpose of generating clonally derived cell lines to produce monoclonal antibodies or vaccine candidates**
+ **Demonstrated ability to produce and screen hundreds of clonally derived CHO or 293 cell lines for top performers**
+ **Hands-on experience with multiple supporting technologies for cell line engineering including cell counting, high-throughput transfection, single-cell cloning/deposition, flow cytometry, automated liquid handling systems, and automated small-scale bioreactor systems**
+ **Expertise in designing and constructing plasmids for gene expression using molecular cloning methods**
+ **Ability to independently design experiments and work plans and manage project timelines for multiple complex projects simultaneously**
+ **Experience preparing technical reports, SOPs, data presentations, and documents needed for technology transfer and regulatory filing**
**Minimum Qualifications:**
+ **Ability to work independently, multitask, and pay close attention to detail.**
+ **Strong written, oral, and visual communication skills.**
+ **Proficiency with Microsoft Word, PowerPoint, or other equivalent software suites**
***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.**
**Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.**
**_This position is contingent upon contract award._**
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