Axle Informatics 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).
Overview
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Scientist to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Vaccine Production Program (VPP).
Responsibilities
- Support the Downstream Process Development (purification) group of the Vaccine Production
- Program (VPP) at the Vaccine Research Center.
- Lead development of mRNA drug substance process, including purification of pDNA,generation and purification mRNA constructs and their subsequent LNP encapsulation.
- Collaborate with formulations team to enable identification and selection of appropriate lipids and LNP composition for downstream development activities.
- Plan and execute design-of-experiments (DOE) studies & high-throughput screening studies for purification process improvements and advancements including parameter optimization, scale-up, process operating window determination and process capability evaluation.
- Lead efforts within the purification group to design, develop and optimize cell culture clarification (depth filtration and/or continuous centrifugation), chromatography, Tangential Flow Filtration (TFF), and Normal Flow Filtration (NFF) processes for all clinical trial vaccine candidates, including antibodies and subunit or nanoparticle vaccines.
- Oversee execution of viral clearance validation studies to support IND-submission and collaborate with external stake holders (VCMP/Vendors/CROs/CDMOs) on study logistics.
- Perform and support purification of research-phase recombinant proteins, mRNA vaccines, virus vaccines and/or virus-like particles in support of other groups at the VRC.
- Interface with key stakeholders (internal and external) to define development strategies and key milestones.
- Clearly communicate results and recommendations to collaborators, colleagues, managers, and senior management, leading project decision-making.
- Present findings at internal department level to institution level meetings and seminars.
- Author and/or review technology transfer documents in support of GMP manufacturing.
- Author and/or review relevant sections of IND submissions.
- Contribute to research publications through internal and external collaborations.
- Pursue novel technologies to advance the capabilities of the VPP.
- Review and publish technical reports and method protocols.
- Write and review process batch records for toxicology batch productions.
Experience Required / Requirements- The ideal candidate will possess a Ph.D. in a Biochemistry, Chemical Engineering, or other life sciences and possess the following:
- 3 – 5 years of experience in industry-related downstream development lab.
- Prior mentorship experience with proven leadership abilities in team-oriented environment.
- Ability to navigate ambiguity and synthesize actionable next steps to move programs and strategies forward.
- Experience with mRNA IVT and purification.
- Proficiency in commonly used techniques and tools for biologics purification and characterization, including column chromatography, TFF, NFF, UV-Vis spectroscopy, etc.
- Demonstrated knowledge of maintaining accurate and detailed records.
- Strong organization, communication, and interpersonal skills, with the ability to drive projects in a highly collaborative work environment.
- Good understanding/knowledge of the overall drug development process, cGMP, and regulatory requirements.
- Familiarity with automation technologies and high-throughput techniques relevant to biologics production and process analyses.
- Experience writing technology transfer documents and IND submission sections related to downstream processes.
- Knowledge of the process scale-down and scale-up.
Benefits- 100% Medical, Dental & Vision premium 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)
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:careers@axleinfo.com 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.