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Job Locations US-MD-Gaithersburg
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 Capital Equipment Manager 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), Gaithersburg, MD. Responsibilities - Oversee and maintain the VPP management of laboratory instruments. - Oversee the VPP capital equipment servicing and repair. - VPP Scientific Operations Support - Develop and implement departmental policies related to primary duties and other aspects of VPP Scientific Operations. - Follow established departmental policies, procedures, and objectives, continuous quality improvement objectives, and safety, environmental, and/or infection control standards. - Perform miscellaneous job-related duties, as assigned, including, but not limited to, performance of property checks, maintenance of service contracts on lab equipment and monitoring inventory levels. - Serve as a primary or backup emergency responder for all VPP REES monitored equipment. - Represent Scientific Operations group at safety meetings. - Operate dolly/pallet jack in loading and unloading supplies and equipment. Experience Required / Requirements - BS degree or Associates degree with 3-4 years of working experience. - Proficient in Microsoft Word/Excel/Outlook. - Database experience is preferred. 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: Email: 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.
ID
2021-1812
Job Locations US-MD-Rockville
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 Scientific Program Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), Vaccine Research Program (VRP), Vaccine Translational Research Branch (VTB), Rockville, MD. Responsibilities - Work with federal staff responsible for GMP product development of vaccines for infectious diseases including the production of investigational products that are identified as strong candidates to move from a preclinical to clinical phase. - Participate as a team member in a group composed of different staffing areas including scientific/technical roles, project management, regulatory affairs, quality assurance, contracts and finance. Activities include participating in both the development of vaccines and adjuvants, assisting in the authoring the Chemistry, Manufacturing and Controls and Toxicology sections of Investigational New Drug submissions, providing protocol and Investigator Brochure review, and assisting in providing oversight of Contract Manufacturing Organizations. - Assist in the evaluation and propose appropriate toxicity studies and models for products intended to be studied as vaccines. - Coordinate with Quality, Regulatory and Technical team members for health regulatory compliance. - Provide regulatory advice and recommendations to the Project Lead for manufacturing projects and pre-clinical studies. - Assist the team with impact/risk assessment from issues, failures and deviations during manufacturing and pre-clinical studies. - Prepare technical reports, updates and summaries for internal meetings with Division Management. - Perform site-visits of CMOs at kick-off or during critical project execution stages or for troubleshooting as requested by the POC. - Review, GMP manufacturing batch records, SOPS, deviation reports, etc. - Participate with Team members to track product stability reports with respect to stability timepoints, review the product stability protocol for consistency and completeness, ensure that the stability program matches the requirement per the project Statement of Work, review stability Certificate of Analysis and/or Stability reports/data for out of specification testing results, issue the Shelf-Life Extension document after reviewing of the stability report. - Assist in the preparation and review of regulatory documents including pre-IND materials, and IND, as required. - Prepare oral and written presentations for internal and external programmatic and scientific meetings. - Participate in on site audits of vendors. Benefits - 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:  Email: 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.
ID
2021-1811
Job Locations US-MD-Rockville
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 Clinical Advisor to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), Office for Policy in Clinical Research Operations (OPCRO), Protection of Participants, Evaluation and Policy Branch (ProPEP), Rockville, MD. Responsibilities - Develop, draft, and compile policy or procedures documents for the Division of AIDS either independently or as part of a working group. - Provide leadership, editorial expertise, and consultative support to the Division of AIDS through creation of Clinical Research policies and related procedures, as well as DAIDS human subjects clinical research policies, in compliance with all applicable US Federal regulations and international guidelines, such as ICH, and other relevant guidelines. - Provide DAIDS staff advice on the interpretation of human subjects’ protections regulations, protocol compliance in human subject protections, and the additional requirements under 45 CFR 46 Subparts B, C, and D as well as other applicable regulations (21 CFR 50, etc.) and guidelines (ICH and others as applicable). - Serve as the subject matter expert, providing expertise on HIV, associated comorbidities (such as TB), etc. needed to evaluate human subject protection issues, and maintain such scientific expertise. - Contribute to the review of individual protocols presented at DAIDS’ Scientific Review Committees, from a human subject protection perspective. - Provide direct human subjects protection support to protocol development teams, clinical operations offices, project specific working groups and other DAIDS and DAIDS’ stakeholders in their oversight of the implementation of DAIDS’ sponsored and/or funded clinical research. - Provide advice to inform the departmental Branch Chief of activities related to policies; perform project management, and administrative tasks related to development and/or modification of policies and procedures. - Conduct in-depth research for development and/or modification of clinical research policies in a variety of areas (for example, clinical trial conduct and oversight, safety, research participant privacy protections). - Review and edit existing policies and procedures per DAIDS QMS process and timelines. - Provide NIH and NIAID-wide benchmarking, policy research, and analyses in support of DAIDS policy development, management, and/or administration. - Serve as a Content Manager for the internal ProPEP policies and procedures and DAIDS external clinical research policy website. - Develop policy briefings for the departmental Branch Chief, OPCRO leadership and/or other DAIDS’ leadership. Experience Required / Requirements - At least five (5) years of relevant experience in the field of human subject protection and policy development. 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:  Email: 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.
ID
2021-1788
Job Locations US-MD-Rockville
Axle Informatics is a bioinformatics and information technology company that offers innovative computer services, informatics, and enterprise solutions to research centers and healthcare organizations around the globe. With experts in 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) Overview We are looking for a Sr. Data Visualization Developerwith a Front-End Developer experience and extensive D3.JS and/or WebGL experience to support projects at the NIH. The position will be based in Rockville, Maryland. We are looking for a skilled and motivated developer with expertise in interactive graphical representation of large data and/or streaming data for 2D and 3D visualizations. The successful applicant will be involved with developing user interfaces and data visualization tools from data acquired in collaboration with scientists, biologists, and/or clinicians across the NIH.   Responsibilities - 5+ years of experience in web-based user-interface design and development.  - Experience building large-scale, reactive web UI frontends:     - UI design using HTML5, CSS, etc.  - Javascript frameworks (e.g. React, Vue.js, Aurelia, Angular, etc).  - Javascript build and bundling tools (gulp, webpack, requirejs, jspm, yarn). - Building interactive graphs using D3.js libraries. - Building interactive visualizations using WebGL  or WebGL based (ie. Deck.GL) libraries. - Finding and integrating custom components in a chosen framework as well as building one from scratch when needed.  - Defining API needs for the client.  - Troubleshooting web applications. - Using debug tools such as Chrome developer tools. - Finding fixing bugs, cross browser issues, performance issues. - Use of message-bus architectures and message queue implementations in a web UI ( http2, websockets, wamp, websockets, server sent events, stomp). - Candidates must be comfortable working with:  - Linux and MacOS operating systems. - A ticket system such as Jira. - A team documentation system such as Confluence. - Source control (git), collaboration tools. - Agile and scrum workflows.    Preferred - Experience with any/all of the following: Plotly Javascript, ParaViewWeb, Tau Charts, C3.js, Nvd3, and/or ReCharts - Experience with any/all of the following: WebGL1.0/2.0, Deck.gl, Luma.gl, three.js, xeo.gl, stack.gl, wgpu, and dawn. - Experience with container (e.g. Docker) technologies. - Experience with build and deployment tools (ie. npm, Jenkins, TravisCL). - Listed examples of open-source work (e.g. GitHub) . - Experience developing for mobile platforms (native or web-based applications) .   Qualifications - Bachelor’s Degree plus 2 years of experience in UI designing, or master’s degree.  - 3-6 years developing and designing visualization platforms. - Strong knowledge and experience with D3.js and/or WebGL. - Excellent communication skills and ability to work in a team environment.     Benefits      - 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 and no vesting period   - Competitive salaries with performance bonus opportunities   - Discount plan for 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:        Email: 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.      
ID
2021-1767
Job Locations US-MD-Gaithersburg
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 Biologist 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), Gaithersburg, MD. Responsibilities - Contribute to the generation of stable cell lines for vaccine and therapeutic protein candidates including monoclonal antibodies, recombinant proteins, and virus-like particles - Independently execute each step of the cell line development process including plasmid production, transfection, single cell cloning, clone expansion in static culture plates and shake flasks, fed-batch analysis, and clone stability studies - Use automated platforms for clone selection and screening - Prepare plasmid DNA using standard molecular cloning techniques - Participate in cell line development platform design, optimization, and cycle-time reduction studies including methods for clone selection, expansion, ranking, and characterization - Perform small-scale process development studies using various culture vessels including tissue culture plates, shake flasks, and small-scale bioreactors - Generate stable pools and perform transient protein production for supply of reagent-grade material - Provide laboratory support for medium preparation, equipment maintenance, and ordering of supplies - Write and review technical reports documenting process development studies and stable cell line generation work - Work with other team members to generate experimental plans for process development studies - Write and review standard operating procedures for cell line development processes and instrumentation - Maintain complete documentation records, including a detailed and up-to-date laboratory notebook, to support regulatory filings - Regularly communicate progress to team lead and present work to cell line development team Experience Required / Requirements - BS in Biological Sciences with a minimum of three (3) years of relevant work experience or MS in Biological Sciences with independent research experience in an academic or industrial setting - Hands-on experience with aseptic technique and mammalian cell culture along with supporting technologies for cell line engineering including cell counting, high-throughput transfection, single-cell cloning, and flow cytometry - Familiarity with molecular cloning methods, PCR, and agarose gel electrophoresis - Experience in preparing technical reports, standard operating procedures, and data presentations - Ability to work independently to execute defined experiments and troubleshoot issues to meet project timelines - Ability to effectively communicate plans, results, challenges and ideas to other team members in oral and written forms - Experience in monoclonal antibody and/or vaccine production preferred 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:  Email: 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.
ID
2020-1764
Job Locations US-MT-Hamilton
We are seeking a Bioinformatics Scientist to join the team at Axle Informatics. 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). Responsibilities - Utilize experience with bioinformatics, randomized schemes, sample prep technology for High Throughput TaqMan, and next-generation sequencing to work with DNA and RNA isolation reagents while maintaining strict adherence to quality and performance in a wet-bench setting. - Work with a variety of samples including in vitro grown bacteria, tissue culture samples, flow sorted samples, human and animal tissues in RNA-protect, RNALater, or Trizol/phenol-based solutions, for RNA, RNA/DNA, or DNA isolations. - Work with randomized schemes pertinent to the sample processing effort. - Work with robotics fluidics stations (Biomek FX, NX) multi-channel pipettors; process single up to 96 and 384 well samples for target preparation for host/pathogen transcriptome profiling. - Prepare sample for High Throughput TaqMan, NGS data generation, High Throughput SNP processing, allelic discrimination assays, and genotyping. Maintain detailed record of laboratory notebook which describes laboratory protocols/methods followed. - Assist in the writing and publication of peer-reviewed manuscripts and reports associated with work performed. Improve the efficiency and effectiveness of projects and technologies. - Develop and optimize new protocols for the lab. - Assist with Next Generation Sequencing data analysis and data interpretation. - Assist and train postbacs, ITTAs, post -doctoral researchers, high school students regarding the use of equipment/computers/software and for assistance on projects.   Qualifications - Master’s degree (or foreign equivalent) in Bioinformatics or a related field plus three years of experience reflecting demonstrable ability in the skill set described above.   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: Email: hr@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.    
ID
2020-1759
Job Locations US-MD-Rockville
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 Data Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Office of the Director (OD), Office of Science Management and Operations (OSMO), Office of Workplace Solutions (OWS),Office of Business Management and Solutions (OBMS), Rockville, MD. Responsibilities - Develop data models or projections based on studying past results, relationships, and OWS data and anticipating future trends. - Analyze and investigate data information from various sources and in various formats. - Analyze data to draw conclusions and identify cause and effect relationships to support OWS leadership. - Develop PowerPoint presentations, communications, and reports of data collected and disseminate them to OWS leadership telling the story of the progress and successes of OBMS/OWS. - Meet with customers to understand their needs or concerns to ensure data, analytics, and reporting are used appropriately. - Consult with appropriate staff and conduct independent studies to develop cost savings model for OBMS/OWS. - Organize data to assist OWS leadership when responding to audits and/or data calls for NIH. - Seek additional resources when gaps and inconsistencies or variations in data are found. - Review Tableau metrics on a weekly basis, determine trends and provide solutions to the OBMS supervisor to ensure effective work distribution and sustained productivity. - Meet bi-weekly or as needed with OBMS supervisor to discuss and review gaps and inconsistencies or variations in data that are found in the various data sources. - Provide consultation as needed to OWS leadership and OBMS supervisor on complex data trends and business intelligence formulation. Experience Required / Requirements - Bachelor’s degree in a related field. - Minimum of five (5) years of related experience. 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:  Email: 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.
ID
2020-1758
Job Locations US-MD-Rockville
Overview   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). Responsibilities - Responsible for analysis, design, implementation, and support of web applications. - Create admin report; and provide analytical support and maintenance after implementation of software using MS Sharepoint 2010 and 2013, JSON, C#, Bootstrap, Angular Material, Angular JS, Node JS, JavaScript, PHP, My SQL, SQL Server, HTML and Gulp/Grunt using AngularJS. - Proficiency required in Microsoft SharePoint 2010 and 2013, JSON, ASP.Net, C#, Bootstrap, Angular Material, Gulp/Grunt.   Qualifications - Master’s in Computer Science.    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)   Mail resumes to: Axle Informatics, 6116 Executive Blvd. Suite 400, North Bethesda, MD 20852   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.     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.    
ID
2020-1740
Job Locations US-MD-Rockville
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 Medical Officer to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), Therapeutics Research Program (TRP), TB Clinical Research Branch, Rockville, MD. Responsibilities - Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of HIV/AIDS, its co-infections and/or related co-morbidities. This includes evaluating the hypothesis, objectives, study design, feasibility, and regulatory requirements, as well as identifying medical and logistical problems that may impede a study. - Advise program management of merits and deficiencies in proposed clinical studies. - Provide subject matter expertise during protocol development leading to review at the Division level and ensure that the concerns raised during the review are addressed by the Protocol Development Team in a timely manner. - Provide clinical expertise to assist in developing Investigational New Drug (IND) applications. Individuals providing this expertise will be named as reviewer of information relevant to the safety of the drug in question, on line 15 and 16 of the IND application (FDA Form 1571). - Evaluate annual IND annual reports for medical safety and report findings to RAB. - Provide medical expertise in protocol follow-up stages for subject safety and protection, reliability of study endpoint data and make appropriate recommendations to DAIDS’ leadership to ensure trials are conducted according to protocol. - Provide clinical and scientific information for preparing NIAID communications to the Food and Drug Administration (FDA), other government and nongovernmental agencies, pharmaceutical companies and Data Safety Monitoring Boards. - Conduct site visits, when necessary, to obtain additional data and information for use by federal staff in the consideration and evaluation of ongoing and future programs. - Preview serious adverse event (SAE) reports providing expert medical advice for potential impact of SAEs in ongoing research and participate in the preparation of reports submitted to the FDA. - Attend and participate in national/international scientific meetings/conferences in order to stay abreast of current research findings and to interact with other investigators to promote collaborations. Experience Required / Requirements - MD or equivalent degree; active Medical license preferred. - Completed training in Internal Medicine or Pediatrics. - Training in Infectious Diseases or Pulmonary Medicine preferred. - Board Certification in Internal Medicine or Pediatrics, Infectious Diseases, or Pulmonary Medicine preferred. - Experience in in clinical trials, especially TB or other infectious diseases preferred. - Experience in TB clinical care or studies preferred. Benefits - 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:  Email: 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.
ID
2020-1732
Job Locations US-MD-Bethesda
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 Biologist/Flow Cytometry Specialist  to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Immunology Laboratory (IML), Flow Cytometry Core (FCC) as well as the ImmunoTechnology Section (ITS), Bethesda, MD. Responsibilities - Perform a wide range of complex procedures in the Flow Cytometry Core Laboratory. Specific techniques may include, but are not limited to, monoclonal antibody conjugation, fluorescent dye chemistry, peripheral mononuclear cell isolation, multiparameter flow cytometry, T cell stimulation assays, immunophenotyping, and tissue culture. - Conduct independent research under the guidance of the Chief, Flow Cytometry Core, including planning, and conducting of experiments, data analysis and peer reviewed publication of data. - Coordinate clinical specimen management, including inventory, sampling, and analysis, in support of the clinical research protocols, in support of the ImmunoTechnology Section. - Calibrate and operate a variety of laboratory instruments under standard guidelines and following Standard Operating Procedures to perform test, analyses, and other procedures. - Interact with scientist 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. - Train laboratory personnel on optimal use of newly built flow cytometry technologies and ensure that the data obtained by those personnel are appropriately generated. - Maintain accurate, daily records of experiments. - Analyze experimental data, prepare summary analyses for presentation and/or publication, and write substantial portions of manuscripts including such data. Experience Required / Requirements - Bachelor’s and/or Master’s with laboratory-based training in immunology or closely related field. - Extensive experience with all aspects of flow cytometry including instrument standardization, calibration, and assay optimization. - Candidates should have excellent written skills and experience in oral presentations. Benefits - 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:  Email: 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.
ID
2020-1714
Job Locations US-MD-Gaithersburg
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 Regulatory Affairs Specialist to join our vibrant team at Gaithersburg, MD. Responsibilities - Responsible for chemistry, manufacturing and controls (CMC) information of all investigational new drug (IND) applications for vaccines, monoclonal antibodies, and related biological products. - Assist regulatory program managers with CMC-relevant responses to comments from regulatory authorities. - Oversee planning, preparation and review of Module 3 sections in Common Technical Document (CTD) format for submission to regulatory authorities. - Ensure documentation follows FDA guidelines and Code of Federal Regulations (CFR). - Interacts collaboratively with VRC Office of Regulatory Sciences and Project Management groups. - Serve as subject matter expert for Vaccine Production Program (VPP) process development staff for raw material sourcing and product testing strategies. - Interact with the VRC pilot plant manufacturing, regulatory and quality assurance staff. - Review and provide comments, recommendations, and strategy on product specifications, stability protocols, comparability protocols and reports, investigator brochures and other related CMC documents during product development of biological products for early phase clinical trials. Experience Required / Requirements - Bachelor’s degree, MS preferred, in life science from an accredited college or university. - Minimum of 8 years progressively responsible experience in Regulatory Affairs. - Must have at least 5 years working with biologics/large molecules CMC preparation in the US. - Must have direct experience assembling Regulatory applications in eCTD format. - Must have demonstrated strong understanding of the U.S. Regulatory requirements. - Must have Expertise in MS Office and SharePoint. 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: Email: 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.
ID
2020-1692
Job Locations US-MT
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 We are seeking a Bioinformatics Specialistpersonnel to join our team in 903 S. 4th Street, Hamilton, MT 59840. Responsibilities - Utilize experience with bioinformatics, randomized schemes, sample prep technology for High Throughput TaqMan, and next-generation sequencing to work with DNA and RNA isolation reagents while maintaining strict adherence to quality and performance in a wet-bench setting. - Work with a variety of samples including in vitro grown bacteria, tissue culture samples, flow sorted samples, human and animal tissues in RNA-protect, RNALater, or Trizol/phenol-based solutions, for RNA, RNA/DNA, or DNA isolations. - Work with randomized schemes pertinent to the sample processing effort. Work with robotics fluidics stations (Biomek FX, NX) multi-channel pipettors; process single up to 96 and 384 well samples for target preparation for host/pathogen transcriptome profiling. - Prepare sample for High Throughput TaqMan, NGS data generation, High Throughput SNP processing, allelic discrimination assays, and genotyping. - Maintain detailed record of laboratory notebook which describes laboratory protocols/methods followed. - Assist in the writing and publication of peer-reviewed manuscripts and reports associated with work performed. Improve the efficiency and effectiveness of projects and technologies. - Develop and optimize new protocols for the lab. - Assist with Next Generation Sequencing data analysis and data interpretation. - Assist and train postbacs, ITTAs, post -doctoral researchers, high school students regarding the use of equipment/computers/software and for assistance on projects. Requirements - Master’s degree (or foreign equivalent) in Bioinformatics or a related field plus three years of experience reflecting demonstrable ability in the skill set described above.   Benefits - 100% Medical, Dental & Vision premium coverage for Employees   - Flexible Spending Accounts - 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:  Email: hr@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.  
ID
2020-1626
Job Locations US-MD-Bethesda
Axle Informatics is a bioinformatics and information technology company that offers innovative computer services, informatics, and enterprise solutions to research centers and healthcare organizations around the globe. With experts in 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).   Axle is seeking a highly ambitious, adaptable, structured, and detail oriented Pharmacovigilance Clinical Program Manager to join our vibrant team at Bethesda, MD.   Responsibilities  - Oversee all aspects of the VRC CTP Pharmacovigilance Program, which leads the process for safety signal management activities, and ensure the detection, assessment, understanding and prevention of safety events for each investigational product (IP) the VRC manufactures for clinical research.  - Provide tactical leadership for the VRC CTP Pharmacovigilance Program/Team.   - Create and adapt pharmacovigilance procedures based on prevailing domestic and international regulations, VRC polices/procedures, etc.  - Review safety events for completeness and trends; analyze comprehensive safety data in consultation with PV team; communicate findings to VRC’s Office of Regulatory Sciences.   - Participate on cross functional, multidisciplinary teams and contribute to defining aggregate reporting guidelines.   - Draft, review and finalize PV data agreements with collaborators who receive VRC-manufactured investigational products.   - Work with VRC’s external partners to gather PV information/data and review it utilizing the PV data system platform (ARGUS).   - Author/provide strategic input or oversight for PV related sections of periodic regulatory documents (i.e. IND annual reports, DSURs, IB updates) according to the agreed process and timelines.   - Monitor and evaluate safety profiles of VRC manufactured investigational products to detect any change in risk profile.   - Collaborate with VRC CTP protocol operations, medical, quality and risk management teams to ensure coordinated and effective risk mitigation strategies throughout the product lifecycle.   - Assign projects and set deadlines for PV Team staff and facilitate PV team meetings.  - Maintain knowledge of vaccine and monoclonal antibody safety profiles and product development status; review relevant biomedical literature or other scientific data.    Experience Required / Requirements   - Clinical Advanced degree (NP, PA, MD, etc.) is required.  - Minimum 3 -5 years’ experience in PV with significant experience in preparing regulatory documents.   - Knowledge of clinical trial and PV methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements in PV  - Experience with MedDRA and drug coding reviews.   - Minimum of 5 to 10 years’ related experience in a biotechnology, pharmaceutical company, government, or CRO environment.   - Strong experience in the conduct and management of clinical trials, especially phase I – III vaccine or monoclonal antibody clinical trials. Strong background in clinical trial drug safety is required  - An understanding of medical terminology and ability to summarize medical information is required.  - Personnel management experience is required.  - Strong attention to detail and follow-up skills is required.   - Must be flexible and willing to take on significant administrative responsibilities.   - Must take initiative and have ability to work independently and as a team member, offering assistance wherever needed.   - Must be able to create contingency plans to deal with possible challenges and roadblocks.   - Good computer and database skills, familiarity with ARGUS platform is preferred.    Benefits - Paid Time Off (PTO) - 10 Paid Federal holidays - Various wellness programs - Employee Referral Bonus Program (ERBP) - Vision coverage through Cigna national network - Dental coverage through Cigna national network - 401(K) with significant company match & no vesting period - Short and Long-Term Disability coverage (paid by company) - Competitive salaries with opportunity for performance bonuses - Discount plan for pet care, legal services, & identify theft protection - Basic Life and AD&D coverage (paid by company; option to purchase additional coverage) - Medical coverage through UHC national network (option to choose between 3 available plans) - 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:                       Email: 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.  
ID
2020-1511