Biologist

Overview

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 around the globe. 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).

• Paid Time Off (Including Holidays)
• Employee Referral Bonus
• 401K Match
• Tuition reimbursement and professional development opportunities
• Flexible Spending Accounts:
  • Healthcare (FSA)
  • Parking Reimbursement Account (PRK)
  • Dependent Care Assistant Program (DCAP)
  • Transportation Reimbursement Account (TRN)

• Develop downstream (purification) processes, under the supervision of a project lead scientist, for recombinant proteins, virus vaccines, and virus-like particles (VLP) that may be used as clinical candidates.
• Design and execute mRNA-Lipid Nanoparticle (LNP) process development studies for mRNA-LNP encapsulation.
• Serve as SME with operation and optimization of microfluidic systems, e.g. Precision Nano System Ignite/Blaze and Knauer Nano Scaler Impingement Jet Mixers.
• Develop scale-down and scale-up operations to advance tech transfer to manufacturing and/or enable troubleshooting.
• Screen and optimize tangential flow filtration processes for mRNA-LNP products to generate preclinical materials and drive tech transfer for clinical manufacturing.
• Design and execute lipid screening studies to evaluate novel lipid components and formulations for use in pre-clinical safety and efficacy studies.
• Collaborate with analytical and formulation scientists to characterize mRNA-LNP formulations and optimize process flows and sample stability.
• Perform in vitro transcription reactions to generate mRNA products.
• Purify research-phase recombinant proteins, virus vaccines and/or virus-like particles in collaboration with other groups or external collaborators.
• Work within the purification group to design, develop and optimize chromatography and filtration step unit operations to drive process development of clinical trial vaccine candidates and monoclonal antibodies (mAbs).
• Collaborate with project management to ensure mRNA-LNP development milestones and study deliverables are met in a timely manner.
• Prepare necessary materials (buffers, packed columns, etc.) for execution of downstream process activities.
• Perform technology transfer of processes to VRC Pilot Plant for manufacture of clinical product through document generation and on-site support.
• Write and review tech transfer documents, technical protocols and reports.
• Generate supporting documents, as necessary, for IND filings and other regulatory needs.
• Analyze and compile data, present at various group/department meetings.

• Bachelor’s degree in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline.
• 5-7 years experience in recombinant protein purification and mRNA-LNP development for GMP clinical-phase products.
• Demonstrated knowledge of maintaining accurate and detailed records.
• 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.
• All support positions required a BS degree; some require MS, MD, or Ph.D.
• The education, skills and relevant years of experience required for each support position are consistent with the minimum requirements for the labor categories specified in the contract.

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, or other characteristics…