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).
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Senior Scientist to join our vibrant team at Gaithersburg, MD.
- Lead a project team for the evaluation and development of stable formulations in the liquid or frozen state (project dependent) for the vaccine candidates at VRC, including the following subtasks:
- Work with the Director of Formulation, Project Management, and Functional Leads from other process teams to develop a formulation development plan, including timeline, that is dictated by the specific product TPP and project requirements.
- Design fit-for-purpose formulation and stability studies.
- Oversee the technical execution of those studies by Formulation personnel, and personally execute studies as needed.
- Analyze, collate and interpret study data (directly and that analyzed by team members) based on technical expertise, previous project experience, organization knowledge and accepted scientific field literature.
- Develop and execute assays for biological product characterization, formulation development and stability testing of recombinant protein-based vaccines, proteinaceous nanoparticles, and virus-like particles.
- Analyze, interpret and present data in small group, department and conference settings.
- Write and review technical reports and protocols documenting formulation, stability and method development studies.
- Contribute directly to regulatory filings in collaboration.
- Represent the Formulation Department and/or the VRC/VPP in one or more of the following:
- Cross functional teams with VRC/VPP development personnel to facilitate overall project objectives.
- Cross functional teams with GMP personnel to facilitate transfer of development procedures to GMP facilities.
- Cross functional teams with external stakeholders as required by project.
- Provide strategic guidance and technical instruction to formulation team members.
- Work in collaboration with personnel to generate and complete professional development goals.
Experience Required / Requirements
- PhD in Pharmaceutics, Chemistry, Biochemistry, or a related discipline.
- MS and three (3) years of relevant additional experience may be considered equivalent to a PhD.
- Three to eight (3 to 8) years industry or industry equivalent non-profit experience in protein and/or protein-based vaccine formulation development.
- Experience in leading a formulation development project, including:
- Planning and executing the development of a protein-based therapeutic or vaccine (pre-formulation through final clinical formulation selection).
- Managing a development team, including technical instruction of junior associates, project scheduling and resource management.
- Hands-on experience with the design and execution of studies for the formulation of protein therapeutics and/or vaccines.
- Strong background in both physical and chemical stability of proteins.
- Hands-on experience in the theory, use, data analysis and data interpretation of the majority of the following techniques:
- Calorimetric Analysis (Differential Scanning Calorimetry and Isothermal Chemical Denaturation).
- Circular Dichroism, Intrinsic and Extrinsic Fluorescence and Uv-Visible Spectroscopies.
- Particle Analysis (MFI, Nanosight, DLS, LO/HIAC).
- Classic protein biochemistry sample handling and analysis (UF/DF, SDS-PAGE, Western Blot).
- Chromatography (SEC, RP).
- Experience in active participation on cross-functional project teams.
- Experience in data analysis and experimental design software packages (e.g. Prism, SigmaPlot, MicroCal Origin, JMP, etc.).
Highly Desirable, but not Required
- Hands-on experience with the development of adjuvants and the evaluation of adjuvant compatibility with biologic vaccines.
- Hands-on experience with GMP biologic fill-finish operations.
- Paid Time Off (PTO)
- 10 Paid Federal holidays
- Generous health coverage provided with no monthly premium to the employee
- Generous vision and dental coverage provided with no monthly premium to the employee
- Short and Long-Term Disability coverage (paid by company)
- Basic Life and AD&D coverage (paid by company; option to purchase additional coverage)
- 401(K) with significant company match & no vesting period
- Competitive salaries with performance bonus opportunities
- Discount plan for pet care, legal services, & identify theft protection
- 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:
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.