Sr. Scientist

Axle is 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)

Axle is looking to add a driven, flexible, organized, and meticulous Sr. Scientist to our dynamic team. The Contractor(s) shall provide services in support of the overall functions of the Vaccine Research Center (VRC), Vaccine Production Program (VPP), Cell Culture Development (CCD).

• Conduct upstream process development and tech transfer of production processes toward clinical manufacturing of VRC vaccine and antibody clinical candidates within the Cell Culture Development group at the VPP.
• Provide subject‑matter expertise to lead scientists and/or associates to develop upstream process methods that meet the productivity and product quality characteristics to achieve successful production of clinical material, including designing optimization studies (e.g., DOE with JMP) and using high‑throughput automated AMBR
  15 and AMBR
  250 bioreactors.
• Use fed‑batch bench‑scale bioreactors and scalable single‑use bioreactors (SUBs) at 50 L to support 250 L, 1000 L, and 2000 L manufacturing vessels.
• Develop pDNA production platform using microbial cell cultures in both shake flask and controller‑programmed stirred‑tank bioreactor formats.
• Collaborate with Project Managers to ensure upstream development milestones are appropriately set and met on time.
• Serve as a subject‑matter expert (SME) in guiding cell‑culture strategies (media/feed evaluation, control parameter tuning, etc.) for new vaccine or therapeutic mAb candidates (both mammalian and microbial cultures).
• Be responsible for process evaluation/finalization and oversight of process‑locked scale‑up runs to generate material for toxicology studies, including editing/approving/executing process protocols andn
• Coordinate closely with Manufacturing teams to ensure timely and scale‑appropriate technology transfer, by writing, editing, and reviewing tech‑transfer documents (Process Descriptions/Process Flow Diagrams).
• Act as Person in Plant or assign designee for initialli>
• Serve as SME in VCMP upstream troubleshooting and facility fit evaluations.
• Serve as the VRC upstream SME in external collaborations.
• Generate necessary regulatory documents to enable IND submissions, FDA response, etc.
• Optimize lab operational space in collaboration with Process Team Operations Manager and VPP Scientific Operations group, implementing and sustaining an optimal productive lab environment (e.g., 5S organizational efforts, KANBAN, or other structural initiatives).
• Encourage and drive innovation to meet new upstream challenges and publicly distribute novel technologies through presentations at national conferences and/or publication in peer‑reviewed journals.

• PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline.
• Minimum of eight (8) years of experience in microbiology and/or cell‑culture research and development.
• 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 require a minimum of a BS degree; some require a MS, MD, or Ph.D.
• The education, skills and relevant years of experience required for each support position are…