(ID: 2026-3648)

Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

Axle is seeking a Scientist to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Allergy and Infectious Diseases (NIAID) located in Bethesda, MD.

Benefits We Offer:

• 100% Medical, Dental & Vision Coverage for Employees
• Paid Time Off and Paid Holidays
• 401K match up to 5%
• Educational Benefits for Career Growth
• Employee Referral Bonus
• Flexible Spending Accounts:
  • Healthcare (FSA)
  • Parking Reimbursement Account (PRK)
  • Dependent Care Assistant Program (DCAP)
  • Transportation Reimbursement Account (TRN)

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.

Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.

The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility: If you need an accommodation as part of the employment process please contact: [email protected]

This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate’s experience, qualifications, skills, and location.