(ID: 2026-3833)

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 located in Gaithersburg, 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)

Additional Qualifications:

Certifications & Licenses

• Ph.D. in Chemical Engineering, Biology, Chemistry, or related Life Sciences field.

• M.S. degree with ≥6 years relevant experience will be considered.

Field of Study

• Miscellaneous Biology

Software

• Powerpoint

• Outlook

• Excel

• Word

Skills

• 5-10 years of experience in industry-relevant recombinant protein process development for GMP clinical-phase products

• Demonstrated knowledge of maintaining accurate and detailed records

• Expertise in the following techniques or tools for protein and mRNA purification and characterization: Column chromatography for protein purification by means of AEX, CEX, affinity, SEC, HIC Column packing and testing AKTA chromatography system Lab scale TFF systems Lab scale nano-filtration systems Qualitative assays including SDS-PAGE and Western Blot UV/vis spectrophotometer

• Must be a team player who can effectively work with members from cross-functional departments

• Strong oral and written communication skills

• Familiarity with computer software including word processing and data evaluation

• Knowledge and use of statistical design of experiments (DoE)

Deliverables:

• Clean Equipment - Ad-Hoc

• Meet with lab members to present updates - Ad-Hoc

Statement of Work Details:

• Develop downstream processes, with minimal oversight, for recombinant proteins such as monoclonal antibodies, subunit or nanoparticle vaccines, mRNA, mRNA-LNP, and virus-like particles (VLPs) that may be used as clinical therapeutic or vaccine candidates. - 1
• Work independently and collaboratively within the purification group to design, develop and optimize pDNA linearization, mRNA in vitro transcription (IVT), chromatography, Tangential Flow Filtration (TFF), and Normal Flow Filtration (NFF) processes for all clinical trial vaccine candidates. - 2
• Apply process optimization methods, such as Design of Experiments (DoE) or other statistical design approaches. - 3

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

• Write and/or review appropriate CMC sections of IND filings (e.g. Process Description Summaries) to support VRC regulatory group.

• Supports laboratory staff on research projects and techniques.

• Work collaboratively with all VPP departments to coordinate schedules, material needs, and other deliverables to advance site-wide project goals.

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

• Support Viral Clearance Validation studies.

• Purify research-phase recombinant proteins, virus vaccines, mRNA and/or virus-like particles in support of other groups at the VRC.

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

• Drive technology transfer of downstream processes to Lab’s Pilot Plant for manufacture of clinical product through document generation and on-site support.

• Write and review technology transfer documents in support of GMP manufacturing.

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

• Perform mRNA encapsulation to provide material generation for assay development and pre-clinical studies.

• Analyze and compile data, present at various group/department meetings.

• Write and review process batch records for toxicology batch productions.

• Coordinates with junior staff to modify research protocols.

• Serve as a functional lead and/or Subject Matter Expert (SME) in an inter-department Chemistry, Manufacturing, and Control (CMC) team with responsibilities for the following processes: in vitro transcription (IVT), chromatography, depth filtration, nano-filtration, and tangential-flow filtration (TFF).

• Train associate scientists in the execution of chromatography, filtration processes, and other newly developed and/or novel production processes.

• Presents research at national scientific meetings and symposia.

• Present results of clinical and experimental research at recognized scientific meetings by lectures and exhibits (poster sessions).

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.

#IND