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Scientist I/II/III, Formulation

Company: PharmaLogics Recruiting
Location: Bethesda
Posted on: May 5, 2022

Job Description:

The person filling this position within the Formulation Development group at the Vaccine Production Program will be part of a dynamic and motivated team working on the characterization, formulation, and development of multiple types of biologic vaccine candidates, including virus-like particles, monoclonal antibodies, and protein nanoparticles. The successful candidate will have a Doctoral degree in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutics, or a related discipline (highly experience Master's degree candidates may also be considered). Hands-on experience with spectroscopic analysis, physico-chemical solution analysis, and/or biologic stability assessment is required. Experience with project leadership and personnel management may also be required for higher level positions. Work-related training, however, is understood to be a career-long process.

The exact responsibilities of the positions will vary with the education and experience of the individual candidate, but are expected to include:

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.
Mentor 2-3 Associate Scientists as follows
Provide strategic guidance and technical instruction, including in method and study deign theory.
Work in collaboration with personnel to generate and complete professional development goals.
Serve as Subject Matter Expert for one or more analytical and/or theoretical areas relevant to formulation development at the VRC.

Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related discipline.
Minimum 2 years of industry, government or equivalent experience in protein or vaccine formulation, stability, characterization, or a related field (post-doctoral experience can apply).
M.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related discipline.
8+ years combination industry, government, and/or academic experience in protein formulation and/or related fields.

Strong knowledge of protein and/or polymer chemistry theory.
Strong understanding of biophysical and bioanalytical properties of proteins and relevant analytical techniques.
Strong experience with hands-on analysis and data interpretation using protein/polymer spectroscopic, calorimetric or particle sizing techniques (E.g. UV-Vis, Fluorescence, Circular Dichroism spectroscopy, DLS, HIAC, DSC, etc.)
Proficiency with one or more data analysis software platforms (E.g. Excel, Prism, SigmaPlot, etc.).
Ability to work independently with minimal supervision.
Time management skills to enable work on multiple projects.
Excellent interpersonal and group communication skills
Strong written communication skills.

Experience with biologic stability and/or forced degradation studies.
Experience with Design of Experiment (DOE) software, design and execution.
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.

Keywords: PharmaLogics Recruiting, Bethesda , Scientist I/II/III, Formulation, Other , Bethesda, Maryland

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