Axle Informatics is a scientific information technology and research company that offers innovative technology, scientific support services, informatics, and enterprise solutions to research centers and healthcare organizations around the globe. With experts in biomedical research, software engineering, bioinformatics and program management, we focus on developing and applying technology tools and techniques to empower decision-making and accelerate the discovery in translational research. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of health (NIH).
We are looking for a Scientific Program Analyst within a core facility to support scientists at the NIH/NIAID Laboratories. The position will be based in Rockville, Maryland.
Basic research to clinical evaluation and towards potential licensure by providing all aspects of oversight and programmatic assistance to support teaching, training, and in vivo research for VRC laboratories.
- Represent the department in various departmental and interdepartmental committees that address scientific and administrative initiatives.
- Provide centralized support and service for all in vivo research, conducts collaborative research and animal model development, and operates a fully accredited laboratory animal facility.
- Plan, manage, and analyze data from animal and clinical studies evaluating immunogenicity of vaccine candidates entering product development.
- Experience in vaccine and therapeutic development research, rodents, and nonhuman primates; familiarity with principles of Good Laboratory Practices (GLP) animal studies and regulatory compliance; and a record of independent research with authorship in peer-reviewed publications.
- Develop assays to support development and/or QC testing as needed to support Analytical program.
- Perform a wide range of complex procedures and techniques (may include, but are not limited to: cell culture, clinical/diagnostic microbiology, DNA analysis, DNA isolation, DNA purification, DNA sequencing, flow cytometry, gene cloning, immunohistochemistry, manipulation of radioactive isotopes, natural product isolation, organic synthesis, peptide synthesis, protein analysis, protein purification, etc.)
- Analyze unique problems involved with regulatory requirements and related scientific analysis.
- Interact with scientists from other organizations or institutions involved in similar or related research projects.
- Interact with students, post-doctoral fellows and non-doctoral research technicians on experimental design and laboratory-based methodologies.
- Design experimental approaches provide critical evaluation of scientific data, mentors scientific staff and collaborates with other scientists; integrates and starts up of new technologies within the laboratory.
- Direct special project activities with particular emphasis on coordinated research efforts among VRC, NIAID, NIH and private, non-governmental organizations.
- Facilitate collaborative efforts with stakeholders, NIAID, HHS, Centers for Disease control and Prevention (CDC), Food and Drug Administration (FDA), academic institutions and private organizations and industries dedicated to expanding the state of knowledge of vaccine health globally, so as to enhance research and clinical readiness, and promote synergy.
- Provide guidance to senior management officials regarding unusual and novel issues relating to broad policy matters and the potential impact on the VRC mission and strategic objectives for the intramural research.
- Apply strategic and scientific expertise to oversee integrated pre-clinical development plans for vaccines against HIV, TB, etc.
- Formulate policies, standards, procedures, and guidelines and ensures dissemination to laboratory staffs for implementation.
- Review and assess science policy regulations and guidelines relating to compliance.
- Develop implementing policies and provides leadership and the necessary oversight to ensure the following:
- Quality assurance of products and/or services produced by the Center
- Compliance of Center-wide program execution with HHS, NIH, and NIAID policies and regulatory guidance,
- Allocation of financial resources to the Center’s consistent workload and the efficient use of personnel,
- Scientific/technical review processes are established within the Center.
- Develop stable formulations for vaccine products, including (but not limited to) antibodies, virus-like particles and recombinant proteins. Oversee multiple development projects, primarily (but not limited to) early phase programs.
- Lead CMC teams comprised of cross-functional representatives. Provide updates to management on progress and issues.
- Author relevant CMC sections of regulatory submissions and serve as Formulation SME as needed for regulatory matters.
- Support formulation/fill/finish technical transfer to Vaccine Clinical Materials Program.
- Collaborate effectively with other groups, including Cell Line, Cell Culture, Purification, Analytical, Quality Control, Regulatory, Clinical, and Manufacturing.
- Experience with protein blotting techniques such as dot/slot and western blots; agarose and acrylamide gel electrophoresis procedures; high-throughput epitope screening and characterization assays such as Octet biolayer interferometry; flow cytometry techniques and analysis techniques; immunological assays such as neutralization and ELISA assays.
- Perform immunizations on mice through intramuscular and intraperitoneal routes; DNA transfections, protein production and purification methods; tissue culture procedures such as culture of immortalized cell lines, and preparation of tissue culture reagents; culture of primary lymphocyte and cell lines; biological methods such as plaque assays, generation of master and working viral stocks, and viral tittering.
- Write reports of findings, stating methods and procedures, including any modifications employed specimens and materials involved, and results of experiments.
- Experience developing fast high-throughput residual DNA Analytica procedures utilizing the Tecan Fredon EVO.
- Develop a direct qPCR assay without DNA extraction to reduce cost.
- Draft and data verification of CMC sections of IND and BLA.
- Perform comparability assessments of bioanalytical techniques.
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.