(ID: 2025-0445)
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).
Benefits:
- 100% Medical, Dental & Vision Coverage for Employees
- 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)
Overview
Axle is looking to add a driven, flexible, organized, and meticulous 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) Downstream group, and management of process development processes.
Technical Requirements:
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.
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.
Work with scientists and/or associates in troubleshooting and improving downstream methods during the development cycle. This includes efforts in designing optimization studies (DOE with JMP) and streamlining efforts to ensure timely development schedules.
Work closely with Project Managers to ensure downstream milestones are appropriately set and met on time.
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).
Responsible for planning and overseeing the downstream processes for toxicology lot material production. This includes editing/approving all process protocols, managing execution thereof, and the generation of production reports following successful campaigns.
Coordinate closely with Manufacturing teams to ensure timely and scale appropriate Technology Transfer is achieved, by pursuing the following:
Write/edit/review tech transfer documents (Process Descriptions/Process Flow Diagrams) to support VCMP downstream process Master Batch Record authoring.
Serve as Person in Plant or assigns team designee for initial VCMP production runs.
Serve as SME in VCMP downstream troubleshooting and facility fit calculations.
Serve as the VRC downstream SME in external collaborations for projects outside of VCMP-path clinical development
Work with regulatory team, as needed, to support IND submissions and other requests.
Oversee viral clearance strategies in relevant downstream processes and directs the viral clearance validation efforts (SEG evaluation of CRO vendors, scale-down method SOP/validation approval, etc.
Encourage and drive innovation to meet new downstream challenges and seeks to publicly
distribute novel technologies through presentations at conferences and/or publication in peer- reviewed journals.
Specific Qualifications:
PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline is required.
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.
Familiarity with computer software including word processing and data evaluation.
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 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.
Accessibility: If you need an accommodation as part of the employment process please contact: [email protected]
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s 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.
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.
Top Skills
What We Do
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, health 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 develop and apply research tools and techniques that 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) by offering the responsiveness of a small business coupled with the experience, breadth, and depth of a large organization.
