Scientist

Guidehouse Inc.; Gaithersburg (MD); On-site; USD 120,000 - 170,000; Full time

Job summary

Guidehouse Inc. in Gaithersburg, MD is seeking a Scientist to independently provide support services to meet NHLBI objectives in a full-time, on-site role.

The position focuses on advancing laboratory science, developing vaccine and biotherapeutic formulations for Phase I/II manufacturing, and leading formulation development activities with cross-functional teams. PhD required and extensive vaccine-related experience; strong data analysis and instrument expertise; ability to manage equipment and

Qualifications

• PhD required in a related discipline.
• Eight years vaccine-related research experience.
• Strong study design, execution, and interpretation in protein/vaccine formulation.
• Hands-on expertise in spectroscopy, rheology, or particle characterization.
• Proficiency with data analysis software (Origin, Prism, etc.).
• Must obtain/maintain a Federal DoD public trust.

Responsibilities

• Advance laboratory science through new procedures and discoveries.
• Develop vaccine/biotherapeutic formulations for Phase I/II manufacturing.
• Lead formulation development activities within a cross-functional team.
• Design experiments, coordinate studies, and ensure data integrity.
• Prepare reports and contribute to manuscripts for publication.
• Present data at regional and national meetings.

Skills

Vaccine formulation

Protein chemistry

Study design

Data analysis

Lab leadership

Education

PhD in Pharmaceutics/Chemical Engineering/Chemistry

Tools

Origin

GRAMS

Prism

SigmaPlot

Job description

Job Family : Scientist

Travel Required : None

Clearance Required : Ability to Obtain Public Trust

What You Will Do:

• We are currently searching for Scientist to independently provide support services to satisfy the overall operational objectives of the NHLBI. This is a full-time, on-site opportunity in Gaithersburg, MD.
• Advance the science in the laboratory through new procedures and discoveries.
• Develop product-specific clinical formulations for vaccines and biotherapeutics for Phase I/II manufacturing under guidance of Federal Task Leaders including: project design, experimental design, study coordination within the Formulation Development group, timeline planning, and evaluation and protection of data integrity.
• 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, and data analysis and interpretation.
• Independently direct and conduct special research projects that have a high priority for the laboratory with special emphasis on the development of novel research treatments.
• Operate, troubleshoot and train others to use laboratory equipment and software.
• Manage scientific equipment and resources (e.g. reagents, stocks of frozen sells, animal samples) including acquisition, documentation and storage.
• Maintain a detailed and up-to-date electronic laboratory notebook detailing all experiments.
• Analyze, collate, and interpret data, utilizing in-depth knowledge of protein chemistry, protein formulation, and method theory, independently and in collaboration with team members.
• Suggest alternative or complementary approaches to experiments.
• Review, edit, and, as needed, write first drafts of papers detailing research efforts and results for publication in peer-reviewed journals,
• Give posters and presentations detailing work at regional and national scientific meetings.
• Lead communications within the VRC/VPP which includes participating in cross-functional teams, coordinating internal and interdepartmental activities, communicating with VRC Project Management regarding timelines and collaborating with other VRC and NIAID groups, and presenting data as needed to support other tasks.
• Search existing literature for new and/or relevant techniques.
• Develop assays for vaccine and biotherapeutic characterization under guidance of Federal Task Leaders which includes designing experiments, incorporating knowledge of Phase 1 assay development principles as outlined in ICH guidelines, and coordinating study activities with the Formulation Development group.
• Evaluate and identify the instrumentation and related technologies for successful assay completion to advise Federal Task Leader, based on subject matter expertise.
• 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 the drafting, reviewing and editing professional manuscripts for peer-reviewed journals based on results of formulation, stability, and method development studies and other similar details of research 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.

What You Will Need:

• PhD. in Pharmaceutics, Chemical Engineering, Chemistry, or a related discipline is required
• Minimum eight (8) of vaccine-related research, at least two years of experience of 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.
• 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).
• Experience with software such as Origin, GRAMS, Prism, SigmaPlot, etc.
• Must be able to obtain and maintain a Federal or DoD "public trust"; candidates must receive approved adjudication prior to onboarding with Guidehouse. Candidates with an active public trust or suitability are preferred.

What Would Be Nice To Have:

• 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 prot