Scientist

(ID: 2026-2887) 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 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) Position Overview A PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline is required, along with a minimum of eight (8) years of experience in recombinant protein purification development for GMP clinical-phase products. Additional Qualifications Certifications & Licenses PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline is required Field of Study Biochemical Sciences Software Familiarity with computer software including word processing and data evaluation Skills Minimum of eight (8) years of experience in recombinant protein purification development for GMP clinical-phase products is required 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 Deliverables Meet with lab members to present updates — Ad-Hoc Statement of Work Details Oversee the development of downstream processes for VRC clinical candidates and the process tech transfer to the VCMP for clinical material generation for the VRC — 1 Provide project support to lead scientists and/or associates to develop downstream process methods that meet the product quality and recovery characteristics to guarantee successful production of clinical material — 2 Work with scientists and/or associates in troubleshooting and improving downstream methods during the development cycle, including efforts in designing optimization studies (DOE with JMP) and streamlining efforts to ensure timely development schedules — 3 Supports the planning and execution of research experiments in the context of the laboratory's overall research program Supports laboratory staff on research projects and techniques Work with regulatory team, as needed, to support IND submissions and other requests Oversee viral clearance strategies in relevant downstream processes and direct the viral clearance validation efforts (SEC evaluation of CRO vendors, scale-down method SOP/validation approval, etc.) Maintains laboratory equipment and the training of others in their use Train staff on the proper usage of laboratory instruments and equipment Assists in maintaining adequate space and facilities for ongoing and projected research studies Coordinate closely with Manufacturing teams to ensure timely and scale-appropriate Technology Transfer is achieved by: writing/editing/reviewing tech transfer documents (Process Descriptions/Process Flow Diagrams) to support VCMP downstream process Master Batch Record authoring; serving as Person in Plant or assigning a team designee for initial VCMP production runs; serving as SME in VCMP downstream troubleshooting and facility fit calculations; and serving as the VRC downstream SME in external collaborations for pro…