(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.
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
Field of Study
Software
Skills
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Minimum of eight (8) years of experience in recombinant protein purification development for GMP clinical-phase products is required
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Demonstrated knowledge of maintaining accurate and detailed records
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Must be a team player who can effectively work with members from cross-functional departments
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Strong oral and written communication skills
Deliverables
Statement of Work Details
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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
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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
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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
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Supports the planning and execution of research experiments in the context of the laboratory's overall research program
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Supports laboratory staff on research projects and techniques
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Work with regulatory team, as needed, to support IND submissions and other requests
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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.)
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Maintains laboratory equipment and the training of others in their use
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Train staff on the proper usage of laboratory instruments and equipment
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Assists in maintaining adequate space and facilities for ongoing and projected research studies
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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 projects outside of VCMP-path clinical development
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Evaluates, analyzes and interprets research data, communicates results and methods in reports, presentations, and manuscripts
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Responsible for planning and overseeing the downstream processes for toxicology lot material production, including editing/approving all process protocols, managing execution thereof, and generating production reports following successful campaigns
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Coordinates with junior staff to modify research protocols
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Presents research at national scientific meetings and symposia
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Encourage and drive innovation to meet new downstream challenges and seek to publicly distribute novel technologies through presentations at conferences and/or publication in peer-reviewed journals
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Provides interpretation of results, guidance, and scientific support to the management team
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Serve as a subject matter expert (SME) in guiding purification strategies for new vaccine or therapeutic mAb candidates (both internal to the downstream team and throughout the VPP)
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Mentors junior level scientists
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Work closely with Project Managers to ensure downstream milestones are appropriately set and met on time
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.
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.
