Scientist

Guidehouse•Gaithersburg, MD

6d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.
Strong oral and verbal communication skills.
Proficient with MS Office suite.
Candidates with an active public trust or suitability are preferred.

Responsibilities

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.
Serve as Formulation Development Subject Matter Expert for one formulation development team.
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.
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.

Benefits

Medical, Rx, Dental & Vision Insurance
Personal and Family Sick Time & Company Paid Holidays
Parental Leave
401(k) Retirement Plan
Group Term Life and Travel Assistance
Voluntary Life and AD&D Insurance
Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
Transit and Parking Commuter Benefits
Short-Term & Long-Term Disability
Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
Employee Referral Program
Corporate Sponsored Events & Community Outreach Care.com annual membership
Employee Assistance Program
Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
Position may be eligible for a discretionary variable incentive bonus