Position Information:

The purpose of this position is to support the Linux-based high-performance computing infrastructure used by NHLBI’s Laboratory of Computational Biology for simulations, modeling, and other scientific research. The SOW requires the contractor to “maintain the LoBoS cluster in good working order,” install and troubleshoot the “Linux operating system,” and support “scientific application programs, scientific databases, programming languages, and tools.” It also requires the contractor to “provision and monitor network storage systems,” perform security patching, and “assist in technology tracking for the purposes of upgrading the LoBoS cluster to continue to support scientific workflows needed by the Lab.

Additional Qualifications:

Certifications & Licenses

• Bachelor’s or Master’s degree

• At least five (5) years of experience in Linux System Administration and/or High-Performance Computing (HPC).

• Minimum fourteen (14) years of progressively responsible professional experience, including experience directing a major program, division, or operational unit.

• Minimum fourteen (14) years of progressively responsible professional experience, including experience directing a major program, division, or operational unit.

• Familiarity with one or more scripting languages.

• Additional experience in the following is ideal:

  • LDAP.

  • MPI.

  • Virtualization and containers.

  • Batch queuing systems such as Slurm.

Field of Study

• Computer Science

• Mathematics and Computer Science

Software

• Expertise with the Microsoft Office Suite and other business-analysis software and applications.

Skills

• Demonstrated ability to conduct needs assessments and develop recommendations for improving current operations.

• Experience collaborating with technical and nontechnical professionals to develop recommendations for current and future initiatives.

• Ability to advise management and staff on the formulation of new strategies and the resolution of sensitive or complex issues.

• Experience developing and implementing proactive programs tailored to specific audiences.

• Strong communication skills, both oral and written.

• Excellent analytical, organizational, and time-management skills.

• Ability to work effectively with staff, management, and other professionals in a collaborative, consultative, and results-oriented environment.

• Strong research, analytical, and problem-solving skills, including the ability to investigate and respond to inquiries concerning policies and operational issues.

• Advanced experience in strategy design, implementation, and evaluation.

• Proven network troubleshooting skills.

Deliverables:

• Run Validation – Weekly

• Inspect Equipment – Weekly

• Meet with lab members to present updates – Bi-Weekly

Statement of Work Details:

• Maintain the LoBoS cluster in good working order and support the reliable operation of associated systems, equipment, and services. – 1
• Maintain the two physical LoBoS cluster spaces, ensuring that facilities, hardware, and related operational requirements are properly coordinated and addressed. – 2
• Conduct needs assessments and develop recommendations for improving current LoBoS operations, infrastructure, and support processes. – 3
• Advise management and staff on sensitive, complex, or technically challenging LoBoS issues and recommend proactive strategies for addressing them. – 4

• Provides executive experience needed to conduct needs assessments and develop recommendations for improvements of current operations.

• Provide strategic management planning and execution, business management, strategic planning, process improvement, metric assessment and measurement, acquisition planning, program management and governance.

• Provide advisory services on a full range of issues relating to administrative management and operational support of the Division.

• Collaborate with staff on program development, contract management, and Institute operations.

• Plan and implement solutions to address gaps and improve performance related to general management practices, management of scientific projects and programs

• Assist with technology tracking and conduct research and analysis to identify modernization, replacement, and upgrade requirements necessary to ensure that LoBoS continues to support the Lab’s scientific workflows.

• Collaborates with other professionals to develop recommendations for current and future initiatives.

• Provide creative counsel on data reporting and formatting.

• Provide advisory services and staff support to executives and senior managers on a full range of issues related to the support of all divisions and centers.

• Monitor system security, identify anomalies, conduct research and analysis, and recommend or implement appropriate resolutions.

• Advises management and staff on formulation of new strategies and sensitive or complicated issues.

• Work with staff to build and guide the execution of individual project plans for prioritized initiatives; manage and track the status.

• Collaborate with staff on the alignment of any proposed changes to enhance the delivery of services and organizational development within the Institute.

• Provide advice on emerging issues affecting

• Work with staff to define a target state for the organization, processes, tools and technology required to meet the evolving needs of the Institute, including responsiveness to scientific and technological advances.

• Collaborate effectively with NIH management, staff, users, and other professionals to implement improvements and resolve operational issues.

• Works with staff to develop and implement new and proactive programs geared to specific audiences.

• Determine solutions to overcome barriers, fill needs, respond to scientific opportunities and develop collaborative solutions.

• Provide input on complex inquiries.

• Review budget spreadsheets and answer questions related to the budget.

• Perform research in support of strategic planning.

• Provide recommendations for internal management, risk assessment and deployment of assets.

• Work collaboratively with NIH staff and other technical and administrative professionals to maintain LoBoS’s Authority to Operate (ATO).

• Assist in developing and implementing proactive programs and improvements tailored to the needs of LoBoS users and the scientific workflows supported by the Lab.

• Assist in managing the budget for LoBoS maintenance and upgrades, including researching requirements, evaluating alternatives, developing recommendations, and supporting implementation.

• Install, configure, maintain, and troubleshoot the following: Linux operating systems, hardware, including desktops, servers, and related infrastructure.

• Conducts research and analysis to proactively address and respond to inquires on various policies and issues.

• Work with staff to develop dynamic web-based and educational content for the program.

• Lead and/or attend and participate in working groups, meetings and conferences.

• Attend national scientific conferences to provide information on programs; present scientific reports; identify potential collaborators.

• Identify Institute-wide digital strategy and target audiences and translate the strategy into user-friendly interfaces that successfully present content, features and functionality appropriately for each audience.

• Perform system patching and other corrective actions to address known vulnerabilities and support ongoing security and operational requirements.

• Coordinate with NIH staff and other professionals to develop recommendations for current and future technology, infrastructure, and operational initiatives.

• Provide timely responses to inquiries concerning LoBoS policies, security, operations, technology, and infrastructure.

• Coordinates and advances professional development and research done by others in areas where other mechanisms may not be optimal due to time constraints or other issues.

• Participate in audits, trainings and site visits as needed.

• Provide facilitation and training for staff.

• Coordinate and advance professional development, technical documentation, and research activities related to LoBoS operations, particularly when standard processes or mechanisms are not optimal because of time constraints or other operational considerations.

Position Information:

Under this task order, the contractor will independently provide support services to satisfy the overall operational objectives of the National Institute on Drug Abuse. The primary objective is to provide services and deliverables through performance of support services. Hours will initially be evenings (11:30-8pm) but may eventually move to include weekends in the future subject to changes in clinic operating hours.

Additional Qualifications:

Certifications & Licenses

• AART certification

Field of Study

• Miscellaneous Health Medical Professions

Software

• MS office suite

Skills

• Interpersonal skills due to extensive participant contact.

Deliverables:

• Work products and documents related to research procedures; operate Siemens scanner for human research utilizing both structural and functional MRI. – Ad-Hoc

• Work products and documents related to performing different pulse sequence and activation paradigms; focus on reproducibility and quality assurance. – Ad-Hoc

• Work products and documents related to performing study testing and observations duties. – Ad-Hoc

• Work products and documents related to acclimating participants with the MRI scanner; perform research related manipulations during MRI experiments. – Ad-Hoc

• Work products and documents related to creating, entering and maintaining data spreadsheets. – Ad-Hoc

• Clean Equipment – Daily

• Inspect Equipment – Daily

Statement of Work Details:

• Ensure that everyone entering the scanner room is appropriately screened for MRI contraindications; maintain records of all MRI screening documentation. – 1
• Ensure that all research participants, patients and visitors are free of metal objects and other exclusion criteria. – 2
• Perform clinical and research MRI procedures on patients, including standard clinical MRI scans or more specialized research studies. – 3
• Collect Magnetic Resonance Imaging (MRI) brain images, functional MRI images and MR spectra (Magnetic Resonance Spectroscopy). – 4
• Ensure that all human experiments conducted follow applicable NIH standards and regulations. – 5

• Perform regular quality assurance procedures on the scanner, data acquisition and archiving of imaging data

• Operate 3T Siemens scanner for human brain research utilizing MR spectroscopy, structural and functional MRI

• Ensure that all human experiments conducted follow applicable NIH standards and regulations

• Act as a participant advocate for participant safety and comfort

• Ensure that MR imaging, behavioral and physiological data collected are of the highest quality

• Execute research projects focusing on reproducibility and quality assurance of different pulse sequence and activation paradigms with the assistance of an MR physicist

• Assist in training research fellows and other NIDA employees to perform MR studies

• Advise staff on any problems that may need attention as well as provide guidance and ensure that scanning logistics, scheduling and supplies are taken care of in a timely fashion

• Ensure that the MRI suite and mock scanner room are clean, in order and appropriately stocked with supplies to provide a clean environment for participants

• Participate in developing and maintaining research protocol documentation and operations

• Operate various research equipment following the training by and supervision of senior PhD MD level personnel Physicists, neuroscientists, physicians including, but not limited to EEG, MRI, TMS, tDCS

• Maintain MRI schedule

• Perform research procedures on research participants and participate in the evaluation of new imaging methods and techniques utilizing Magnetic Resonance Imaging MRI and transcranial magnetic stimulation TMS

• Create multiple redundant backups of all imaging data acquired, including past (historic) studies

• Executes research projects focusing on reproducibility and quality assurance of different pulse sequence and activation paradigms with the assistance of an MRI Physicist.

• Set up all MRI-specific equipment and matrix camera, coils and display equipment for functional imaging.

• Operate the control console during scanning, including selecting proper imaging sequence.

• Execute research projects focusing on reproducibility and quality assurance of different pulse sequence and activation paradigms with the assistance of an MR physicist.

• Perform regular quality assurance procedures on MRI scanner and instruments.

• Organizes data into computerized data sets.

• Archive all image data and transfer of clinical images to the PACS system and the research data to off-line computer workstations; ensure that all study information is available in PACS and ready for radiologist review.

• Transfer both raw and post-processed images and data to specified databases and/or secure storage media (secure external hard drives and/or DVDs), where they can be stored safely.

• Log all scans performed in the appropriate logbook.

• Enter participant/patient data at start of scanning and monitor data acquisition during scanning.

• Create, enter and maintain research data on associated reports and spreadsheets.

• Ensure that MR imaging, behavioral and physiological data collected are of the highest quality.

• Collect and archive MRI data.

• Acts as subject/patient advocate, monitoring comfort and subject cooperation with experimental protocol physiological parameters (pulse rate, respiration, oxygen saturation), and length of time of research exams.

• Adhere to safety precautions and procedures that govern the MRI Facility.

• Ensure the participant’s or patient’s safety and comfort throughout scanning using the patient monitoring system.

• Transfer, position and instruct research participants and/or patients regarding the procedure to obtain the desired radiographic results as specified by the research study.

• Act as a participant advocate for participant safety and comfort.

• Perform all aspects of standard clinical imaging – prepare the patients to be scanned; explain the MRI procedure; address MRI safety screening for contraindications.

• Operates the scanner during both anatomical and functional imaging experiments.

• Operate the MRI scanner doing structural and functional imaging and MR spectroscopy studies, which are part of clinical research studies.

• Operate the control console during scanning; select proper imaging sequences; operate peripheral hardware for effective image and data acquisition.

• Perform standard clinical and more specialized research MRI procedures on patients (e.g., functional MRI, diffusion MRI, MR spectroscopy).

• Schedules investigators’ time on the scanner.

• Assist in scheduling of research participants for MRI scans to achieve a smooth flow and optimal utilization of the Facility.

• Solves MRI related technical questions by designing and performing independent technical research work.

• Attend staff meetings to indicate MRI protocol progress/issues.

• Trains users on how to operate the scanner and gain independence in their experiments.

• Track all training and coordinate renewal of training.

• Provides input to decide what modifications of the unit are necessary to produce optimum image spectra and most efficient use of the scanner.

• Schedule and coordinate all non-routine scanner maintenance.

Overview

Axle is currently hiring for a Health Communications Manager/Science Writer to work with the NIAID Division of Intramural Research and turn complex research findings and policy information into clear, accurate materials for scientific leaders, administrators, and general audiences. The role will prepare scientific summaries, briefings, recommendation memos, and other documents; collaborate with leadership policy guidance; and review materials and workflows for accuracy and efficiency.

Background

The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to understand, treat, and prevent infectious, immunologic, and allergic diseases. The Division of Intramural Research (DIR) is a component of NIAID, one of the largest Institutes of the National Institutes of Health (NIH). DIR’s purpose is to make scientific discoveries that promote the development of new vaccines, diagnostics, and therapeutics that improve human health.

This position provides expert scientific writing, analytical, and policy advisory support to the NIAID Division of Intramural Research (DIR) in the recruitment, appointment, recognition, and retention of its scientific workforce. Drawing on in-depth subject-matter knowledge and command of Title 42, Title 38, and SBRS authorities, the incumbent drafts and reviews recommendation memos, justification documents, award nominations, salary benchmarks, briefing materials, and plain-language scientific summaries; performs quality assurance of Livelink personnel workflows; provides surge coverage for Case Development Specialists; advises senior and program-level managers on policy interpretation and implementation; and identifies tools and process improvements to strengthen operations.

Location: 

This position is primarily in the NIH/NIAID facility in Rockville, MD but can also encompass the Bethesda, MD or Hamilton, MT campuses. 

Qualifications: 

• Master’s Degree or higher in a biomedical research field.

• Coordinates community outreach efforts and activities for the program.

• Attends and gives presentations at major conferences or meetings and participates in discussion with community groups.

• Establishes collaborative relationships with a variety of community organizations (e.g. community health centers, state medical agencies, managed care organizations).

• Coordinates the analysis and evaluation of outreach activities, including internal and external partnership.

• Works closely with management to coordinate content of materials, advertisements and marketing messages.

Specific Expectations

• Provide support based on an in-depth knowledge of the subject matter, write, and edit recommendation memos and other justification documents for scientific positions.

• Produce work products articulate, interpret, and explain complex research findings using plain language. The products are typically intended for viewing by general audiences, both scientific and administrative.

• Assist and collaborate with NIH scientific and administrative leadership on policy interpretation and implementation.

• Provide work products and documents related to providing recommendations guidance on Title 42 and policies, procedures, and requirements at meetings with senior level and program level managers, and via telephone and email.

• Provide coverage of case work for Case Development Specialists as needed, such as supporting personnel packages.

• Prepare a wide variety of briefing materials and complex scientific summaries on a broad range of diseases and research areas.

• Develop specialized materials such as reports and memos covering highly complex subject matter areas for various purposes and audiences.

• Provide advice and conduct reviews for accuracy of multiple materials prepared by other DIR division staff.

• Develop scientific and technical materials regarding DIRs research programs and activities as well as scientific accomplishments.

• Provide support to committee management teams as needed.

• Perform business analysis of personnel action tracking tools and determine next steps.

• Identify tools/software to improve operations.

• Draft and review award nominations and related documents.

• Draft and review salary benchmarks in support of T42, T38 and SBRS appointments, conversions, and pay adjustments and related documents.

• Review Livelink workflows to provide quality assurance for appointments, conversions, and pay adjustments.

• Perform additional project work or duties at the request of task leader.

• Complete training required by NIH.

Additional Qualifications:

Certifications & Licenses

• Ph.D.

Field of Study

• Miscellaneous Biology

• Multi-Disciplinary or General Science

Software

• Graphing and reference and bibliographic software

• MS Office

• SharePoint

Skills

• Medical/scientific computer databases to search and collect information

• Designing and creating documents, using desktop publishing software and office tools

• Data analysis and graphing

• Scientific Writing and Communication

• Project management, website content management

Deliverables:

• Monthly status reports to include information on current and completed activities; problems encountered; corrective actions taken; and recommendations for the next reporting period – Monthly

• Status reports to assess progress, as requested by the Task Leader – Ad-Hoc

• Meet with lab members to present updates – Monthly

Statement of Work Details:

• Apply current scientific and industry best practices in clinical trial data analysis, data management workflows, interpretation of clinical research findings, and scientific writing. – 1
• Monitor the work of the data analysis and scientific writing team members and provide senior scientific and technical leadership for team activities and deliverables. – 2
• Promote quality and consistency across data analysis and scientific writing team activities and deliverables through standardized approaches, collaborative review, application of best practices, and identification of opportunities for continuous process improvement. – 3
• Maintain an integrated view of DASW projects and deliverables, including key milestones, dependencies, timelines, emerging issues, and resource or schedule constraints. – 4
• Facilitate coordination and communication among DASW team members and clinical, laboratory, statistical, data management, regulatory, operational, and other personnel involved in clinical research. – 5

• Develops and assists staff implement policies and procedures related to the organization’s scientific programs.

• Serve as Team Lead of the VRC CTP Data Analysis and Scientific Writing (DASW) team and provide senior scientific and technical leadership for team activities and deliverables.

• Coordinate and prioritize DASW activities and assignments in alignment with CTP clinical research priorities, study timelines, regulatory and public reporting requirements, and available resources.

• Maintain an integrated view of DASW projects and deliverables, including key milestones, dependencies, timelines, emerging issues, and resource or schedule constraints.

• Track team activities and deliverables; identify potential risks, delays, competing priorities, or other issues that may affect timely completion of work; and provide recommendations for resolution or escalation to CTP leadership, as appropriate.

• Serve as a primary DASW point of contact for CTP leadership and other CTP functional teams and participate in CTP Team Leads meetings.

• Provide updates on DASW priorities, accomplishments, timelines, risks, resource needs, and other operational matters.

• Facilitate coordination and communication among DASW team members and clinical, laboratory, statistical, data management, regulatory, operational, and other personnel involved in VRC clinical research.

• Provide technical guidance, mentorship, and training to DASW Scientific Advisors and other team members and support onboarding, knowledge transfer, and development of consistent scientific practices across the team.

• Promote quality and consistency across DASW activities and deliverables through standardized approaches, collaborative review, application of best practices, and identification of opportunities for continuous process improvement.

• Facilitate resolution of cross-functional scientific or operational issues affecting DASW activities and communicate unresolved or significant issues to appropriate CTP leadership.

• Collects, analyzes and creates scientific program information.

• Review scientific and analytical deliverables prepared by PhD-level DASW Scientific Advisors to promote scientific rigor, accuracy, completeness, consistency, and adherence to applicable requirements.

• Verify that clinical trial objectives and endpoints related to immunogenicity, pharmacokinetics (PK), and other assigned scientific analyses are appropriately addressed in study analyses and reporting.

• Review clinical trial analyses and results to assess whether conclusions are scientifically supported by the available data and are presented accurately and consistently across reports, publications, presentations, and other scientific communications.

• Verify that applicable clinical trial results are prepared and reported in accordance with relevant public reporting requirements and established CTP processes and timelines.

• Support appropriate management and documentation of clinical trial analytical data and verify that final data and analyses are maintained or archived in designated data management systems in accordance with applicable procedures.

• Review scientific content prepared for peer-reviewed publications, clinical trial result summaries, scientific presentations, posters, and other communications to promote clear, accurate, and appropriately contextualized reporting of VRC clinical trial findings.

• Apply current scientific and industry best practices in clinical trial data analysis, data management workflows, interpretation of clinical research findings, and scientific writing.

• Coordinates workshops and reports their outcomes.

• Serve as Chair of the VRC Scientific Review Committee and coordinate the scientific review of VRC clinical trial protocols in collaboration with committee members and other subject matter experts.

• Facilitate timely completion and documentation of scientific reviews and resolution of scientific comments to support protocol development and review.

• Provide subject-matter expertise in immunology, vaccinology, translational research, and the clinical evaluation of novel vaccines and monoclonal antibodies to CTP leadership, clinicians, scientists, and internal and external collaborators.

• Provide scientific and analytical consultation during clinical research planning and protocol development, including review of study objectives, endpoints, sampling strategies, and approaches for analysis and interpretation of clinical and immunologic data.

• Review and provide scientific input on Data Management and Sharing Plans, Analytical Plans, Statistical Analysis Plans, and other study-specific documents relevant to clinical trial data generation, analysis, and reporting.

• Collaborate with clinical investigators, statisticians, laboratory scientists, data managers, and other subject matter experts to promote alignment among protocol objectives, laboratory assessments, analytical methods, and planned statistical analyses.

• Evaluates current scientific programs and determines if changes need to be made.

• Coordinate with VRC laboratory and research scientists to monitor development, qualification, and readiness of assays required to support primary, secondary, and exploratory clinical trial objectives and endpoints.

• Track assay-development activities and timelines, identify dependencies or schedule variances that may affect clinical trial analyses or reporting, and communicate significant issues and recommendations to appropriate project teams and CTP leadership.

• Facilitate coordination among clinical, laboratory, statistical, and DASW personnel to support appropriate interpretation and integration of clinical and laboratory data.

• Participate as a member of the Sample Management team and coordinate clinical data and biological sample sharing with approved academic, government, and other research collaborators in accordance with applicable protocols, agreements, policies, and procedures.

• Provide scientific consultation regarding the selection and use of clinical samples and associated data to support collaborative translational research objectives.

• Assists with analyzing current scientific programs and developing and proposing new initiatives.

• Lead or contribute to the development and review of manuscripts, abstracts, scientific presentations, posters, clinical trial result summaries, and other scientific communications describing VRC clinical research.

• Present clinical trial findings and related scientific work through oral presentations and scientific posters at approved internal and external scientific meetings and conferences.

• Collaborate with investigators and multidisciplinary study teams to interpret clinical trial findings and communicate their scientific significance accurately and clearly to appropriate scientific and general audiences.

• Support publication planning and tracking of scientific deliverables to facilitate timely dissemination of VRC clinical research findings.

• Collaborates with management and prepares reports to keep them updated on new and ongoing programs and activities.

• Facilitate biannual reviews of DASW work instructions and related procedures and recommend revisions to improve scientific quality, consistency, efficiency, and cross-functional coordination.

• Coordinates staff responsible for developing, installing and maintaining scientific programs.

• Participate in biannual quality audits of the DASW and Sample Management teams and evaluate findings relevant to team processes and deliverables.

• Analyzes current policies and procedures and suggests and develops improvements.

• Draft or coordinate procedural revisions and other corrective or improvement measures in response to audit findings, recurring issues, changes in requirements, or identified opportunities for process improvement.

• Assists in preparing and developing future strategic plans.

• Monitor implementation of approved procedural changes and assess their effectiveness in improving DASW workflows and deliverable quality.

• Prepares and provides educational materials to staff.

• Identify trends, recurring challenges, and opportunities to standardize or improve clinical trial analysis, data management, scientific review, and scientific writing processes.

• Works closely with management to develop new initiatives that further scientific research.

• Facilitate sharing of best practices, lessons learned, and relevant scientific or procedural updates across the DASW team and collaborating CTP functional groups.

• Uses scientific expertise to review grant proposals and interacts with potential grantees to obtain additional information.

• Interact with scientists as needed to help overcome technical hurdles or provide additional insights or expertise regarding the preparation of scientific protocols.

• Develops project management documentation.

• Track team activities and deliverables; identify potential risks, delays, competing priorities, or other issues that may affect timely completion of work; and provide recommendations for resolution or escalation to CTP leadership, as appropriate.

• Review scientific and analytical deliverables prepared by PhD-level data analysis and scientific writing (DASW) team scientific advisors to promote scientific rigor, accuracy, completeness, consistency, and adherence to applicable requirements.

• Track assay-development activities and timelines, identify dependencies or schedule variances that may affect clinical trial analyses or reporting, and communicate significant issues and recommendations to appropriate project teams and CTP leadership.

• Draft or coordinate procedural revisions and other corrective or improvement measures in response to audit findings, recurring issues, changes in requirements, or identified opportunities for process improvement Monitors and reports progress to project owners.

• Serve as a primary DASW point of contact for clinical trial program leadership and other program functional teams and participate in Team Leads meetings.

• Provide updates on DASW priorities, accomplishments, timelines, risks, resource needs, and other operational matters.

• Facilitate coordination and communication among DASW team members and clinical, laboratory, statistical, data management, regulatory, operational, and other personnel involved in clinical research.

• Conducts project analysis and reports to upper management.

• Review and provide scientific input on Data Management and Sharing Plans, Analytical Plans, Statistical Analysis Plans, and other study-specific documents relevant to clinical trial data generation, analysis, and reporting.

• Facilitate resolution of cross-functional scientific or operational issues affecting DASW activities and communicate unresolved or significant issues to appropriate program leadership Develops and tracks project budgets.

• Provide updates on DASW priorities, accomplishments, timelines, risks, resource needs, and other operational matters.

• Identify trends, recurring challenges, and opportunities to standardize or improve clinical trial analysis, data management, scientific review, and scientific writing processes.

• Researches project management best practices and new industry standards.

• Facilitate sharing of best practices, lessons learned, and relevant scientific or procedural updates across the DASW team and collaborating program functional groups.

• Support appropriate management and documentation of clinical trial analytical data and verify that final data and analyses are maintained or archived in designated data management systems in accordance with applicable procedures.

• Provides subject matter expertise and support to other project managers.

• Provide technical guidance, mentorship, and training to data analysis and scientific writing team members and other team members and support onboarding, knowledge transfer, and development of consistent scientific practices across the team.

• Provide scientific and analytical consultation during clinical research planning and protocol development, including review of study objectives, endpoints, sampling strategies, and approaches for analysis and interpretation of clinical and immunologic data.

• Collaborate with clinical investigators, statisticians, laboratory scientists, data managers, and other subject matter experts to promote alignment among protocol objectives, laboratory assessments, analytical methods, and planned statistical analyses.

• Develops overarching program and project management standards to ensure consistency and quality.

• Facilitate biannual reviews of data analysis and scientific writing teamwork instructions and related procedures and recommend revisions to improve scientific quality, consistency, efficiency, and cross-functional coordination.

Position Information:

Provide scientific staffing support for the Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID)

Additional Qualifications:

Certifications & Licenses

• Bilingual Spanish speaker preferred

Field of Study

• Health and Medical Administrative Services

Software

• MS Office

Skills

• Minimum of at least 5 years of clinical research experience and 2 years of team lead experience

Deliverables:

• Run Validation – Monthly

• Meet with lab members to present updates – Daily

Statement of Work Details:

• Assist, coordinate and implement all components of clinical research protocols, including pre and post research activities, internal and external to the clinical setting. – 1
• Assist study team members in developing an understanding of study design and rationale and support team members in implementation and study procedures. – 2
• Anticipate and mitigate risks and unplanned circumstances impacting patient qualification and data collection. – 3

• Supports clinical staff develop, implement and maintain clinical research data files and materials.

• Ensure ICH GCP compliance with execution of protocols, patient enrollment and follow up, adverse event management and reporting and study activities.

• Request and initiate the purchase of materials, supplies and equipment.

• Demonstrate skills in navigating and troubleshooting a wide variety of e-clinical technologies.

• Collects research data and prepares information for inputs and analysis.

• Supports the development of forms and questionnaires.

• Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.

• Provide technical experience needed to operate the administrative functions within the clinic.

• Monitors subject’s progress and reports adverse events.

• Establish relationships with non-research departments as needed for essential workflow within the clinical departments.

• Supports assembly, development and review of new research projects.

• Design recruitment and retention plans to support the study.

• Supports the creation and management of clinical websites and web-based tools.

• Work to implement the policies and procedures of the program with the clinical research team.

• Organizes and performs clinical research, utilizing internet and other available clinical resources.

• Supply study progress metrics for weekly reporting.

• Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.

• Ensure ICH GCP compliance with execution of protocols, patient enrollment and follow up, adverse event tracking and study activities.

• Supports clinical staff develop, implement and maintain clinical research data files and materials.

• Design and implement quality assurance and quality-control procedures within the day-to-day research activities.

• Develops and facilitates training to new research coordinators and mentors’ researchers in Good Clinical Practices.

• Monitor efficiency of procedures and contribute to the development of SOPs and internal processes to enhance the quality of study conduct.

Additional Qualifications:

Certifications & Licenses

• Ph.D. in Chemical Engineering, Biology, Chemistry, or related Life Sciences field.

• M.S. degree with ≥6 years relevant experience will be considered.

Field of Study

• Miscellaneous Biology

Software

• Powerpoint

• Outlook

• Excel

• Word

Skills

• 5-10 years of experience in industry-relevant recombinant protein process development for GMP clinical-phase products

• Demonstrated knowledge of maintaining accurate and detailed records

• Expertise in the following techniques or tools for protein and mRNA purification and characterization: Column chromatography for protein purification by means of AEX, CEX, affinity, SEC, HIC Column packing and testing AKTA chromatography system Lab scale TFF systems Lab scale nano-filtration systems Qualitative assays including SDS-PAGE and Western Blot UV/vis spectrophotometer

• 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

• Knowledge and use of statistical design of experiments (DoE)

Deliverables:

• Clean Equipment – Ad-Hoc

• Meet with lab members to present updates – Ad-Hoc

Statement of Work Details:

• Develop downstream processes, with minimal oversight, for recombinant proteins such as monoclonal antibodies, subunit or nanoparticle vaccines, mRNA, mRNA-LNP, and virus-like particles (VLPs) that may be used as clinical therapeutic or vaccine candidates. – 1
• Work independently and collaboratively within the purification group to design, develop and optimize pDNA linearization, mRNA in vitro transcription (IVT), chromatography, Tangential Flow Filtration (TFF), and Normal Flow Filtration (NFF) processes for all clinical trial vaccine candidates. – 2
• Apply process optimization methods, such as Design of Experiments (DoE) or other statistical design approaches. – 3

• Supports the planning and execution of research experiments in the context of the laboratory’s overall research program.

• Write and/or review appropriate CMC sections of IND filings (e.g. Process Description Summaries) to support VRC regulatory group.

• Supports laboratory staff on research projects and techniques.

• Work collaboratively with all VPP departments to coordinate schedules, material needs, and other deliverables to advance site-wide project goals.

• Maintains laboratory equipment and the training of others in their use.

• Support Viral Clearance Validation studies.

• Purify research-phase recombinant proteins, virus vaccines, mRNA and/or virus-like particles in support of other groups at the VRC.

• Assists in maintaining adequate space and facilities for ongoing and projected research studies.

• Drive technology transfer of downstream processes to Lab’s Pilot Plant for manufacture of clinical product through document generation and on-site support.

• Write and review technology transfer documents in support of GMP manufacturing.

• Evaluates, analyzes and interprets research data, communicates results and methods in reports, presentations, and manuscripts.

• Perform mRNA encapsulation to provide material generation for assay development and pre-clinical studies.

• Analyze and compile data, present at various group/department meetings.

• Write and review process batch records for toxicology batch productions.

• Coordinates with junior staff to modify research protocols.

• Serve as a functional lead and/or Subject Matter Expert (SME) in an inter-department Chemistry, Manufacturing, and Control (CMC) team with responsibilities for the following processes: in vitro transcription (IVT), chromatography, depth filtration, nano-filtration, and tangential-flow filtration (TFF).

• Train associate scientists in the execution of chromatography, filtration processes, and other newly developed and/or novel production processes.

• Presents research at national scientific meetings and symposia.

• Present results of clinical and experimental research at recognized scientific meetings by lectures and exhibits (poster sessions).

Position Overview

The Automated Cell Technologist will support ongoing NCATS research activities that require compound management services. Responsibilities include completing standard and submitted service and maintenance requests in a timely fashion to prevent loss of government resources. The technologist will also provide reports detailing usage and current inventory amounts of all Drug Enforcement Administration (DEA) controlled substances per federal requirements. Other core duties include maintaining active and stored cell lines in accordance with standard operating procedures (SOPs) to ensure viability, and maintaining quality assurance/quality control (QA/QC) of the NCATS chemical inventory. A Master’s degree is required, with Biology listed as the field of study.

Additional Qualifications

Certifications & Licenses

• Master’s degree

Field of Study

• Biology

Software

• PowerPoint
• Outlook
• Excel
• Word

Skills

• Cell culture, primary cell culture, and 3D cell culture
• Transfections
• Pipetting
• Maintaining stock solutions
• Inventory management
• SOP writing
• Data presentation

Deliverables

• Run validation — Quarterly
• Meet with lab members to present updates — Bi-Weekly

Statement of Work Details

• Advance the science in the laboratory through new procedures and discoveries.
• Train staff on the proper use of laboratory instruments and equipment, and operate, troubleshoot, and train others to use laboratory equipment and software.
• Work with staff to confirm assay results and evaluate new techniques and instruments; search literature; propose, design, and test alternative assays for difficult screening targets; and develop secondary assays.
• Review, edit, and, as needed, write first drafts of papers, posters, and manuscripts.
• Produce research reports and regularly communicate results to staff and collaborators.
• Support the planning and execution of research experiments in the context of the laboratory’s overall research program.
• Evaluate new techniques, instruments, and software for potential incorporation into current SOPs.
• Design and conduct experiments and studies requiring broad professional knowledge of scientific theories and principles.
• Oversee a state-of-the-art core facility serving the NIH community and review the associated budget.
• Propose and investigate new target projects for initiation based on novelty and relevance to human health.
• Support laboratory staff on research projects and techniques, including assay design and method development using an array of experimentation.
• Review scientific data to determine whether a research program can be developed around an idea or data package.
• Assist in maintaining adequate space and facilities for ongoing and projected research studies.
• Manage scientific equipment and resources (e.g., reagents, stocks of frozen cells, animal samples), including acquisition, documentation, and storage.
• Evaluate, analyze, and interpret research data, and communicate results and methods in technical reports, presentations, and manuscripts.
• Coordinate with junior staff to modify research protocols.
• Work with Principal Investigators to schedule and prioritize instrument usage.
• Present research through posters and presentations at regional and national scientific meetings and symposia.
• Write papers and abstracts detailing research efforts and results for publication in peer-reviewed journals, and prepare PowerPoint presentations as appropriate.
• Provide interpretation of results, guidance, and scientific support to the management team.
• Assist lab staff in creating and preparing documents required by the lab’s scientific activities.