Scientist

Position Overview

The Scientist will lead the development of cell culture processes for clinical vaccine or therapeutic candidates at NIAID. This includes process technology transfer for clinical-grade material manufacture to enable clinical trials. The Scientist will establish production processes using advanced bioreactor systems and develop robust processes for toxicological-grade material generation and scalable current Good Manufacturing Practice (cGMP) production. The role also serves as the subject matter expert (SME) for technology transfer deliverables, regulatory submissions, and project planning. A Ph.D. in Biochemistry, Chemical Engineering, or another life sciences field is required, along with 15 years of experience in mammalian and/or microbial cell culture development.

Certifications & Licenses

• None specified

Field of Study

• Chemical Engineering

Software

• Outlook

Skills

• 15 years of experience in mammalian and/or microbial cell culture development

Deliverables

• Provide reports — Ad-Hoc

Statement of Work Details

• Lead development of cell culture processes for clinical vaccine or therapeutic candidates, including process technology transfer for clinical-grade material manufacture to enable clinical trials.

• Serve as the SME for technology transfer deliverables, regulatory submissions, and project planning.

• Establish production processes for cell culture workflows using advanced bioreactor systems and complex growth strategies.

• Drive innovation and adoption of new technologies, such as scalable tangential flow filtration (TFF)-based transient transfection methods.

• Support the planning and execution of research experiments in the context of the laboratory's overall research program.

• Plan, design, and maintain execution of experiments that develop robust processes for toxicological-grade material generation and scalable cGMP production.

• Support laboratory staff on research projects and techniques.

• Maintain upstream project schedules for cell culture through coordination with project management, cell line development, and downstream processing groups.

• Maintain laboratory equipment and train others in its use.

• Drive an upstream/cell culture project from conception to clinical manufacturing by developing processes that require operation of bioreactors and other cell culture equipment, and provide support as required.

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

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

• Participate in the laboratory's review of future proposals for resource allocation.

• Evaluate, analyze, and interpret research data, and communicate results and methods in reports, presentations, and manuscripts.

• Participate in project and laboratory meetings, keep current with compliance obligations, and take responsibility for maintenance of the laboratory and equipment.

• Capture process development study results and process descriptions in lab notebooks and other technical documents to drive standard operating procedure (SOP) generation, project review, and approval.

• Coordinate with junior staff to modify research protocols.

• Work with Principal Investigators to schedule and prioritize instrument usage.

• Present research at national scientific meetings and symposia.

• Research and implement industry-leading technologies to optimize cell culture systems and methodologies.

• Investigate cell culture science in depth and apply results to improve overall processes for VPP production runs.

• Provide interpretation of results, guidance, and scientific support to the management team.