Kelly Services Senior Vaccine Formulation Scientist - NIH - Gaithersburg, MD in Gaithersburg, Maryland
Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking a Senior Vaccine Formulation Scientist to work at the National Institutes of Health in Gaithersburg, MD.
This is a long-term contract position which offers:
Competitive compensation and comprehensive benefit package
Optional health, vision, and dental plans
Vacation leave as well as 10 paid federal holidays and 401K plan.
Access to NIH’s unparalleled resources and niche scientific initiatives
TASKS/SERVICES. The contractor shall:
Lead a project team for the evaluation and development of stable formulations in the liquid or frozen state (project dependent) for the vaccine candidates at VRC, including the following subtasks
Work with the Director of Formulation, Project Management, and Functional Leads from other process teams to develop a formulation development plan, including timeline, that is dictated by the specific product TPP and project requirements.
Design fit-for-purpose formulation and stability studies.
Oversee the technical execution of those studies by Formulation personnel, and personally execute studies as needed.
Analyze, collate and interpret study data (directly and that analyzed by team members) based on technical expertise, previous project experience, organization knowledge and accepted scientific field literature.
Develop and execute assays for biological product characterization, formulation development and stability testing of recombinant protein-based vaccines, proteinaceous nanoparticles, and virus-like particles.
Analyze, interpret and present data in small group, department and conference settings.
Write and review technical reports and protocols documenting formulation, stability and method development studies.
Contribute directly to regulatory filings in collaboration
Represent the Formulation Department and/or the VRC/VPP in one or more of the following:
Cross functional teams with VRC/VPP development personnel to facilitate overall project objectives.
Cross functional teams with GMP personnel to facilitate transfer of development procedures to GMP facilities.
Cross functional teams with external stakeholders as required by project.
Provide strategic guidance and technical instruction to formulation team members.
Work in collaboration with personnel to generate and complete professional development goals.
REQUIREMENTS. The contractor must have:
Ph.D. in Pharmaceutics, Chemistry, Biochemistry, or a related discipline.
M.S. and 3 years of relevant additional experience may be considered equivalent to a PhD
Three to eight (3 to 8) years industry or industry equivalent non-profit experience in protein and/or protein based vaccine formulation development.
Experience in leading a formulation development project, including:
Planning and executing the development of a protein-based therapeutic or vaccine (pre-formulation through final clinical formulation selection)
Managing a development team, including technical instruction of junior associates, project scheduling and resource management.
Hands-on experience with the design and execution of studies for the formulation of protein therapeutics and/or vaccines.
Strong background in both physical and chemical stability of proteins.
Hands-on experience in the theory, use, data analysis and data interpretation of the majority of the following techniques:
Calorimetric analysis (Differential Scanning Calorimetry and Isothermal Chemical Denaturation)
Circular Dichroism, Intrinsic and extrinsic Fluorescence and Uv-Visible spectroscopies
Particle analysis (MFI, Nanosight, DLS, LO/HIAC)
Classic protein biochemistry sample handling and analysis (UF/DF, SDS-PAGE, Western Blot)
Chromatography (SEC, RP)
Experience in active participation on cross-functional project teams.
Experience in data analysis and experimental design software packages (e.g. Prism, SigmaPlot, MicroCal Origin, JMP, etc.).
Highly Desirable, but not Required:
Hands-on experience with the development of adjuvants and the evaluation of adjuvant compatibility with biologic vaccines
Hands-on experience with GMP biologic fill-finish operations
PLEASE APPLY ONLINE
When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.
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