Scientist

PriceSenz


Job Location:

Gaithersburg, MD - USA

Monthly Salary: Not Disclosed
Posted on: 2 days ago
Vacancies: 1 Vacancy

Job Summary

Work Location

IC: NIAID

Street: 9 West Watkins Mill

Bldg: N/A

Room: 200

City: Gaithersburg

State & Zip: MD 20878

Work Hours

Weekly Hours

FT: 30-40 hours per week

# Of Hours

40

Position Requirements

Overall Position Summary and Objectives

Min Education

Resume Max Pages

Recompete of PSTSS 829

Masters

15

Additional Qualifications

Certifications & Licenses

- None - Pharmaceutics Chemical Engineering Chemistry or a related discipline is required.

Field of Study

- Pharmacy Pharmaceutical Sciences and Administration - Chemical Engineering - Chemistry

Software

- Powerpoint - MS Project - MS Access - Origin - GRAMS - Prism - SigmaPlot - Outlook

Skills

- UV-Visible fluorescence - Circular Dichroism and/or IR spectroscopy

- Differential Scanning Calorimetry - Isothermal Chemical Denaturation - Rheology/Viscosity Particle characterization (dynamic/static light scattering static light scattering HIAC and/or MFI/FlowCam) - Minimum of 2 years academic industry or government experience in protein vaccine or biotherapeutic formulation. - Strong experience with study design execution and interpretation in the areas of protein and/or vaccine formulation and stability. Practical knowledge of current practices in protein therapeutic and/or vaccine development for clinical trials. - Extensive knowledge of protein chemistry bioanalytical and biophysical properties of proteins and vaccines. Knowledge of protein formulation theory. Extensive hands-on expertise including data analysis and underlying theory with three or more of the following techniques: UV-visible fluorescence Circular Dichroism and/or IR spectroscopy; Differential Scanning Calorimetry; Isothermal Chemical Denaturation Rheology/

Viscosity Particle characterization (dynamic/static light scattering static light scattering HIAC and/or MFI/FlowCam).

Statement of Work Details

Supports the planning and execution of research experiments in the context of the laboratorys overall research program.

  • Advance the science in the laboratory through new procedures and discoveries. 1
  • Develop product-specific clinical formulations for vaccines and biotherapeutics for Phase 1/II manufacturing under guidance of Federal Task Leaders including: Project design Experimental design Study coordination within the Formulation Development group Timeline planning Evaluation and protection of data integrity 2

Supports laboratory staff on research projects and techniques.

  • Independently direct and conduct special research projects that have a high priority for the laboratory with special emphasis in the development of novel research treatments.
  • Serve as Formulation Development Subject Matter Expert for one formulation development team in the areas of: Formulation theory and experiment design Experiment execution and instrument operation Data analysis and interpretation 3

Maintains laboratory equipment and the training of others in their use.

  • Operate troubleshoot and train others to use laboratory equipment and software.

Assists in maintaining adequate space and facilities for ongoing and projected research studies.

  • Manage scientific equipment and resources (e.g. reagents stocks of frozen sells animal samples) including acquisition documentation and storage.

Evaluates analyzes and interprets research data communicates results and methods in reports presentations and manuscripts.

  • Maintain a detailed and up-to-date electronic laboratory notebook detailing all experiments.
  • Analyze collate and interpret data employing in-depth knowledge of protein chemistry protein formulation and method theory independently and in collaboration with team members.

Coordinates with junior staff to modify research protocols.

  • Suggest alternative or complementary approaches to experiments.

Presents research at national scientific meetings and symposia.

  • Write papers and abstracts detailing research efforts and results for publication in peer-reviewed journals; prepare PowerPoint presentations as appropriate.
  • Review edit and as needed write first drafts of papers posters and manuscripts.
  • Give posters and presentations detailing work at regional and national scientific meetings.
  • Lead communications within the VRC/VPP including: Participation in cross-functional teams Coordination of internal and interdepartmental activities Communication with VRC Project Management regarding timelines Collaboration with other VRC and
  • NIAID groups Presentation of data in all the above as needed to support other listed tasks

Provides interpretation of results guidance and scientific support to the management team.

  • Search existing literature for new and/or relevant techniques.
  • Develop assays for vaccine and biotherapeutic characterization under guidance of Federal Task Leaders including: Experimental Design incorporating knowledge of Phase 1 assay development principles as outlined in ICH guidelines Study Coordination within the Formulation Development group Evaluation and identification of instrumentation and related technologies for successful assay completion to advise Federal Task Leader based on subject matter expertise. Analyze and interpret data Perform bench side sample analyses using both standard and advanced study specific analytical methods as needed to further VRC Formulation Development projects and/or support other project teams. Prepare technical reports and protocols documenting formulation stability and method development studies including drafting reviewing editing and verification of data. Contribute to professional manuscripts based on results of formulation stability and method development studies including drafting reviewing editing and verification of data. Provide general technical guidance and training to Formulation team members. Oversee external service and execute routine maintenance and troubleshooting for one or more pieces of laboratory instrumentation.

Mentors junior level scientists.

  • Train staff in a wide variety of techniques used in the laboratory.
Work Location IC: NIAID Street: 9 West Watkins Mill Bldg: N/A Room: 200 City: Gaithersburg State & Zip: MD 20878 Work Hours Weekly Hours FT: 30-40 hours per week # Of Hours 40 Position Requirements Overal...