• Scientist

    GAP Solutions Inc (Bethesda, MD)


    Scientist

    Job Details

    Level

    Experienced

    Job Location

     

    National Institutes of Health (NIH) - Main Campus/Bethesda - Bethesda, MD

    Position Type

    Full Time

    Education Level

    Ph.D.

     

    Travel Percentage

     

    None

     

    Job Category

     

    Public Health

    Description

    **Position:** Scientist

    **Total Hours/Week:** 40 hours/week

    **Pay and Benefits:** This is a full-time position that pays an annual salary of $137,750 - $154,250. Benefits include medical, dental, vision, paid time off, holiday time, and 401K. See more at GAPsi.com/benefits/.

    **Employer:** GAP Solutions Inc., 205 Van Buren Street, Ste. 205, Herndon, VA, 20170

    **Work Location:** GAP Solutions, Inc. (A System One, LLC Company), 40 Convent Drive, Bethesda, MD 20892. Teleworking is permitted 2 days/week.

    **Respond To:** Qualified applicants can email resumes to [email protected] and reference “Scientist”. No phone calls please.

    **Position Objective:** GAP Solutions, Inc., seeks a Scientist in Bethesda, Maryland to support the Downstream Process Development (purification) group of the Vaccine Production Program (VPP) at the Vaccine Research Center.

    Duties and Responsibilities:

    + Lead development of mRNA drug substance process, including purification of pDNA, generation and purification mRNA constructs and their subsequent LNP encapsulation.

    + Collaborate with formulations team to enable identification and selection of appropriate lipids and LNP composition for downstream development activities.

    + Plan and execute design-of-experiments (DOE) studies & high-throughput screening studies for purification process improvements and advancements including parameter optimization, scale-up, process operating window determination and process capability evaluation.

    + Lead efforts within the purification group to design, develop and optimize cell culture clarification (depth filtration and/or continuous centrifugation), chromatography, Tangential Flow Filtration (TFF), and Normal Flow Filtration (NFF) processes for all clinical trial vaccine candidates, including antibodies and subunit or nanoparticle vaccines.

    + Oversee execution of viral clearance validation studies to support IND-submission and collaborate with external stake holders (VCMP/Vendors/CROs/CDMOs) on study logistics.

    + Perform and support purification of research-phase recombinant proteins, mRNA vaccines, virus vaccines and/or virus-like particles in support of other groups at the VRC.

    + Interface with key stakeholders (internal and external) to define development strategies and key milestones.

    + Clearly communicate results and recommendations to collaborators, colleagues, managers, and senior management, leading project decision-making.

    + Present findings at internal department level to institution level meetings and seminars.

    + Author and/or review technology transfer documents in support of GMP manufacturing.

    + Author and/or review relevant sections of IND submissions.

    + Contribute to research publications through internal and external collaborations.

    + Pursue novel technologies to advance the capabilities of the VPP.

    + Review and publish technical reports and method protocols.

    + Write and review process batch records for toxicology batch productions.

    Qualifications

    Education Requirements and Experience Requirements:

    + Qualified applicants must have a Ph.D. in Chemistry, Biochemistry, Chemical Engineering, or a foreign equivalent.

    + Qualified applicants must have two (2) years of post-baccalaureate experience as a Scientist or a substantially similar position in the following: 1) mRNA IVT and purification; 2) Utilizing biologics purification and characterization, including column chromatography, TFF, NFF, UV-Vis spectroscopy; 3)Maintain laboratory records; 4) knowledge of the overall drug development process, cGMP, and regulatory requirements; 5) knowledge of automation technologies and high-throughput techniques relevant to biologics production and process analyses; 6) Writing technology transfer documents and IND submission sections related to downstream processes; 7) Knowledge of process scale-down and scale-up.

    *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 [email protected] . 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.