(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.