Frederick National Laboratory for Cancer Research

Frederick National Laboratory for Cancer Research Frederick, MD, USA
Sep 20, 2019
Full time
The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases. KEY ROLES/RESPONSIBILITIES Support manufacturing laboratory functions Maintain bacterial and mammalian cell cultures Operate/troubleshoot single use and stainless-steel bioreactors, benchtop lab equipment, GMP autoclaves, and other associated equipment Follow standard operating procedures Complete batch production records under current good manufacturing practices Document in detail, through the use of batch production records, the processes and manufacturing steps taken during the procedures Lead production activities in the manufacturing area Train others within the working group and provide feedback to the manager Interface with quality control/quality assurance Write/revise standard operating procedures (SOP) Assist with investigations, write initial deviation responses BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college or university (according to CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency In addition to education requirements, a minimum of five (5) years of progressively responsible job-related experience with progressively responsible job-related experience in a pharmaceutical cGMP environment Experience with cGMP cell culture manufacturing and production equipment Ability to troubleshoot cell culture process and associated equipment, especially experience with bioreactors Ability to assist in complex investigations including root cause analysis and corrective action determination Working knowledge of cGMP's as they relate to manufacturing operations Ability to write and follow standard operating procedures Ability to assist in writing master batch records and complete Batch Production Records under Good Manufacturing Practices Ability to be gown certified Cleanroom and BL2 experience Ability to lift up to 35 pounds and work in a BL2 environment This position may require working on 2 nd or 3 rd shift and weekends as needed Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Previous lead associate experience a plus Ability to interface with Quality Control, Quality Assurance, Materials Management, Facilities and Validation JOB HAZARDS Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Sep 20, 2019
Full time
The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases. KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL Reporting to the Purification Manager, the Manufacturing Associate I will: Operate chromatography skids, tangential flow filtration skids, cGMP autoclaves, and basic laboratory equipment Perform chromatography resin packing in various sizes and types of chromatography column hardware Perform in-process sampling Perform operation and changeover of equipment Perform filter integrity testing Follow Standard Operation Procedures (SOP) Complete Batch Production Records under cGMP Document in detail, using Batch Production Records or laboratory notebooks, the processes and manufacturing steps taken during the procedures BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency No experience required beyond Bachelor's degree Ability to be gown certified Ability to lift up to 35 pounds This position may require working on 2nd or 3rd shifts and weekends as needed Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Working knowledge of cGMPs and computer-assisted manufacturing and production equipment Clean room and BL2 experience Skills/experience in processes and equipment associated with column chromatography techniques from small to pilot scale Experience in the operation of chromatography skids Experience in the operation of tangential flow filtration skids Experience in operation of UnicornTM software Experience in chromatography column packing/qualification JOB HAZARDS OR REQUIREMENTS Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Sep 20, 2019
Full time
The Human Resources (HR) Directorate of Leidos Biomedical Research, Inc. (LBR), located in Frederick, MD, is responsible for developing and administering programs that support the recruitment, compensation, development, and performance assessment of the personnel required by LBR to successfully operate the Frederick National Laboratory for Cancer Research. KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Human Resources Business Partner is responsible for providing consultative human resources support to the Leidos Biomedical Research organization. This position is responsible for ensuring alignment of business objectives, work cultures, and human resources/programs/policies to facilitate the organization with achieving its business goals while minimizing risk to the organization. The Human Resources Business Partner is responsible for: Serves as a consultant to management on human resources-related issues and initiatives Acts as an employee champion and change agent Partners with assigned Directorates and their direct reports to proactively identify opportunities to enhance organizational performance and functionality Assesses and diagnoses overall organizational climate to ensure overall 'well-being' of the client organization in order to increase employee productivity and commitment, including positive employee relations, employee communication strategy, performance management and goal setting, employee surveys, optimal staffing levels, and overall employee involvement Collaborates with senior management to develop strategy for improving organizational climate across multiple business units Understands organization's business strategies and aligns human resource strategy and programs to achieve the business goals, including alignment of staffing, development, and compensation programs Partners with senior management to identify opportunities to better leverage human resources program Collaborates with other members of HR Team to implement the HR strategy, including representing client's business strategy and expectations, representing Human Resources to the business units, and reconciling issues that create conflict between Human Resources and business unit strategy Provides business consultations services and delivery of core HR programs and processes in the areas of talent acquisition, organizational effectiveness, talent management and succession planning, employee relations, retention, and performance management Supports reduction-in-force and unemployment claim determination activities Assists with the delivery of training when needed, such as new manager assimilation and front-line supervisory training Supports immigration/visa programs as appropriate Performs other related duties as assigned BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency In addition to the educational requirements, a minimum of five (5) years of experience as a Human Resources Business Partner One (1) year of project management skills and experience with a drive for results Experience with HRIS Systems such as Peoplesoft, SAP, Workday, etc., with the ability to run reports and do analysis Experienced in MS Office tools and resources, specifically Excel, including PowerPoint, Excel and Word Knowledge of commonly-used HR concepts, practices and procedures Strong leadership skills, excellent communication and presentation skills Ability to work with highly confidential and sensitive information where discretion is essential Experience providing all functions of Human Resources as a strategic business partner to a fast-paced and changing organization Must be adept at working with management to influence/facilitate change, implement strategy and accomplish objectives Interpersonal relations: particularly tact, sensitivity, professionalism, confidentiality and diplomacy Strong verbal and written communication skills, with a friendly and professional approach to customer service Ability to work independently, set priorities and meet conflicting deadlines with a high level of accuracy. Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS PHR/SPHR Certification Experience with Costpoint Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Sep 20, 2019
Full time
The Research Subcontracts Department provides acquisition support to the Frederick National Laboratory for Cancer Research (FNLCR) as well as operations and specific subcontracting support for the NCI-Bethesda, National Institute of Allergy and Infectious Diseases (NIAID)and other related Government initiatives. Specifically, Subcontracting provides pre and post-award acquisition and administration for highly complex research programs, scientific services, field trials, and related projects at FNLCR through execution of agreements with third parties, often commercial companies and non-profit research institute and universities. KEY ROLES/RESPONSIBILITIES The Senior Subcontract Administrator will be responsible for the full range of pre-and post-award subcontract administration duties to include the following: Drafting often times complex solicitations Managing source evaluations, negotiations & award as well as modifications, Determining appropriate contract type (cost reimbursement, time & materials, fixed price) Inclusion of FAR flow-downs, other Agency supplemental flow-downs and special provisions Submitting required action for Government approval or advance notification to subcontract when required Preparing correspondence, documentation, certification, final reporting, and product delivery for major contracts Subcontract file documentation to satisfy internal audit, Government CPSR audit, and internal P&P's Providing guidance and work leadership to less-experienced contract administrators Maintaining current knowledge of relevant contractual practices and procedures Participating in special projects as required BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education); Foreign degrees must be evaluated for U.S. equivalency In addition to the education requirements, a minimum of five (5) years of experience in contracts/subcontracts administration in a Government services company Must have knowledge of cost reimbursement subcontracting as well as Fixed-price and T&M subcontract types Should have a good understanding of Federal Acquisition Regulations (FAR) as applicable to subcontracting in support of a Government Prime Contract Experience identifying shifting risk through solid negotiation skills Possess skills drafting cost/price analysis and adherence to compliance in a Government services contract environment Must be able to obtain and maintain a security clearance Strong written and verbal communication skills PREFERRED QUALIFICATIONS Applied knowledge of Federal contracting and commercial contracting Relevant applied experience in international programs and subcontractors Project/program management as it relates to supporting overall programs from the subcontracting perspective Excellent software skills (Word, Excel, etc.) Familiar with performance based Statement of Work Ability to lead a programmatic subcontract support effort and provide strategy development to the programs related to subcontracting support Ability to think critically to solve unique subcontracting strategy development t and handle multiple high visibility critical tasks simultaneously Ability to interact professionally with program staff, senior management and Government customers Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Bethesda, MD, USA
Sep 20, 2019
Full time
Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program's mission has contributed to improving the overall standards of public health on a global scale. KEY ROLES/RESPONSIBILITIES The Clinical Monitoring Research Program Directorate (CMRPD) provides clinical program administrative support to the clinics operated by the Office of the Clinical Director (OCD), Center for Cancer Research (CCR), National Cancer Institute (NCI) at the National Institutes of Health (NIH). Assists with the administration of the complex clinical program and ensures major components and initiatives in the areas of patient care, clinical research staff recruitment, training and resource management are well integrated and move forward efficiently and effectively Interacts with various internal and external groups to facilitate clinical trials research and develop administrative procedures Acts as liaison between outpatient clinics, the Clinical Center and other departments Identifies solutions for day-to-day problems by adapting processes and procedures with consideration to the coordination of patient care Assists in monitoring, control and reporting on clinical budgets Develops project timelines and tracks the progress of clinical projects Prepares reports and reviews sections of submissions, abstracts and presentations Completes special projects Tracks progress, and monitors/prepares budget operating reports Works in conjunction and collaboration with NCI academic clinical scientists, research investigators and/or groups that participate in clinical research trials or influence clinical research Responsible for implementing operating guidelines utilizing standard NCI Policies and Standard Operating Procedures (SOPs) Reviews operational requirements for development of or changes to staffing Performs assignments and tasks independently; however unusual or difficult problems are referred for review to the Administrative Director Supervises other administrative clinical support staff This position is located in Bethesda, Maryland BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency. In addition to the educational requirements, a minimum of six (6) years of responsible administrative experience in a hospital or medical environment, including two (2) years in a supervisory capacity Experience should include work with protocols, clinical site management, data collection and analysis Must possess general knowledge of clinical trial fieldwork concepts and practices, regulatory requirements and guidelines for clinical research and monitoring requirements Must be well versed in Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs) Must be able to perform project management-type tasks for multiple clinical research protocols Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Familiarity with State Department Regulations and FARs Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Sep 20, 2019
Full time
The Contracts and Acquisitions (C&A) directorate provides all contract management, export control, purchasing, subcontracting, receiving, warehousing, distribution, and transportation services in support of the Frederick National Laboratory for Cancer Research (FNLCR) operations including NCI-Bethesda, National Institute of Allergy and Infectious Diseases (NIAID) and other institutes. KEY ROLES/RESPONSIBILITIES Participates in complex contract and task order proposal preparation, negotiations, administration of government contracts, and interaction with customers in accordance with company's policies and procedures, applicable laws, customer's requirements, and sound business judgment Reviews contractual documents to ensure adherence to company policy, government specifications and requirements, and conformance to master agreements Assesses critical contract obligations and contract provisions, to include gaps and risks. Advises on contract revisions to better meet the needs of company Helps to identify and mitigate potential organizational, personal and financial conflicts of interest in accordance with regulation and company policies Performs other related duties as assigned by a responsible authority Communicate effectively and proactively, orally and in writing, with senior level management in both corporate and government levels Work in a contract environment both independently and within a team. Must be detail-oriented and possess strong organizational skills with the ability to prioritize multiple concurrent complex tasks Demonstrate effective negotiation techniques to resolve the most complex matters Demonstrated working knowledge of systems utilized and regulations such as: Federal Acquisition Regulations (FAR) and other government regulations, policies, and procedures; administration of cost reimbursement contracts, including indefinite delivery, indefinite quantity (IDIQ) contracts/task orders; principals of contract law; and best practices in contracting processes and procedures. Proficiency in word processing systems, i.e., Microsoft Office or similar system BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency. In addition to educational requirements, a minimum of seven (7) years of progressively responsible experience in contracts administration. Must be able to obtain a security clearance Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Sep 20, 2019
Full time
The mission of Enterprise Information Technology (EIT) is to develop an enterprise-level, consolidated information technology infrastructure that provides exceptional IT capabilities to the Frederick National Labs for Cancer Research (NCI-Frederick/FNLCR) in support of basic, translational, and clinical cancer and AIDS research. The IT Operations Group (ITOG) is a part of Enterprise Information Technology (EIT) within Leidos Biomedical Research, Inc. ITOG is responsible for computational servers, storage servers, virtual machine infrastructure, and the FNLCR network. ITOG focuses on implementing enterprise IT best practices in the areas of computational services, storage, backup, and archiving; batch and application support; server consolidation and virtualization; network infrastructure; unification of voice, teleconferencing, and video communication technologies; and improved infrastructure for collocation of dedicated servers. KEY ROLES/RESPONSIBILITIES THIS POSITION IS CONTINGENT ON FUNDING APPROVAL Provide system management and administration functions, including requirements analysis, systems configuration and performance monitoring, Responsible for ensuring the availability, reliability and security of the Linux operating system in both physical and virtual environments, Install and maintain hardware, software, and applications, Evaluate user needs or problems and takes appropriate action to resolve them, Implement proof of concept models for new technologies prior to release in to the production environment, Monitor system performance and makes adjustments to the system software or hardware when required, Participate in the integration of hardware and software which will include interfacing with hardware and software vendors for support, Adhere to configuration management principles across development, stage, and production environments. BASIC QUALIFICATIONS Level III Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation.(Additional qualifying experience may be substituted for the required education).Foreign degrees must be evaluated for US equivalency In addition to the education requirements, a minimum of five (5) years of experience installing and maintaining CentOS Linux Experience in deploying virtual machine servers from VMware templates Experience administering Apache web and tomcat servers Experience in installing and maintaining physical servers Experience in installing and maintaining hardware, software, and applications Experienced in shell, perl, or python scripting Assists in batch infrastructure configuration and daily operations Level IV Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation.(Additional qualifying experience may be substituted for the required education).Foreign degrees must be evaluated for US equivalency In additional to the education requirements, a minimum of eight (8) years of experience installing and maintaining CentOS Linux Experience administering Apache web and tomcat servers Experience with puppet/satellite/foreman configuration managers Proficientin shell, perl, or python scripting Proficient in one or more compiled languages (C, fortran, C++) Technical experience in compiling, installing, and testing open-source scientific applications Excellent problem management and troubleshooting skilles and abilities to diagnose and resolve system related problems Develops and maintains detailed and accurate documentation of Linux and application related procedures All candidates must have the following: Understanding of IT systems best practices such as ITIL and the implementation of these practices, including the documentation and testing of systems Excellent communication and customer service skills Must be able to obtain and maintain a security clearance. PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: Experience with bioinformatics applications Experience with container software such as Docker Experience with Cisco UCS and/or HPE blade technologies Experience with Ubuntu Linux Experience in working in an Active Directory environment Medium level understanding of TCP/IP based networking Medium level understanding of network file systems MySQL, mariadb, MS SQL, or Oracle experience Medium level understanding of system and application security Moderate skills with Microsoft Office products EXPECTED COMPETENCIES Build new servers from existing custom cd images or VM templates Update patches of operating systems and applications Configure systems to meet NCI/NIH/HHS security and functional standards Monitor system performance and make adjustments to hardware and/or software to mitigate problems Functional understanding of interactions between network, network storage, and operating systems Create, review, and update Standard Operating Procedures (SOP) and Service Level Agreements (SLA) Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Sep 20, 2019
Full time
The Facilities Maintenance and Engineering (FME) Directorate is responsible for laboratory space, administrative space, infrastructure, campus landscape, planning, design, maintenance and construction management at Frederick National Laboratory for Cancer Research. KEY ROLES/RESPONSIBILITIES Interprets the requirements for customer requests based on engineering drawings, specifications, sketches, and statements of work. Identifies, inputs and analyzes data required and/or data sources for cost estimates. Gathers relevant data and calculates cost of projects. Documents cost analysis results and creates formal presentation to the customer. Written documentation explains the estimate approach and elements, allowing decision-makers to make informed choices. Significant deviations, key points, cost drivers and cost results are analyzed and explained as well as alternatives considered during the estimate development Documents effective procedures regarding estimating process to ensure consistent, accurate estimates are prepared. Defines a systematic, quantifiable modeling approach to analyze projects. Assists in the development of such models. Performs other duties as assigned by a responsible authority. Communicate effectively, both verbally and in writing. Interface and communicate with a wide range of functional areas in a highly technical environment. Requires ability to analyze quantitative and historical information and make recommendations to project management personnel. Working knowledge of electronic spreadsheet and database programs (Excel, Access); Experience with Means-based estimating and estimating software tools, such as cost to derive construction costs. Knowledgeable in the Principles of Finance, Budgeting and/or Project Management. BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency In addition to educational requirements, a minimum of eight (8) years relevant experience Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS AACE or SCEA Certification JOB HAZARDS OR REQUIREMENTS Candidate is subject to the following environmental conditions such as working outdoors, high humidity areas indoors, dampness and chilling, dry atmospheric conditions, etc. as part of the job Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Rockville, MD, USA
Sep 19, 2019
Full time
Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program's mission has contributed to improving the overall standards of public health on a global scale. KEY ROLES/RESPONSIBILITIES The Clinical Monitoring Research Program Directorate (CMRPD)/Clinical Trials Reporting Office (CTRO) supports the NCI's Clinical Trials Reporting Program (CTRP), which maintains a database of information on NCI-supported clinical trials. The CTRO team creates and maintains clinical trial summary records in the CTRP database. These records serve the NCI for portfolio analysis purposes and they are the source for information used to support the cancer research grants review process. Some of the clinical trial information that the CTRO abstracts is fed to public clinical trial search websites including Cancer.gov and ClinicalTrials.gov. Triage electronic requests from cancer centers to appropriate personnel and respond to requests within 24-48 hours of receipt Responds to inquiries and resolves issues addressed by the cancer research community or stakeholders utilizing effective communication Organize and monitor issues using an issue/ticket tracking system Investigate accrual (patient enrollment) and data report inquiries from NCI-designated cancer centers. Review and analyze CTRP and external source systems to reconcile data, and coordinate with the stakeholders to investigate and rectify data discrepancies. Initiate and provide CTRP user training reviews of data reports, trial registration for site administrators and members Manage and perform data update projects, follow up with centers to answer questions on trial registration, funding categorization, participating site statuses and accrual discrepancies Imports NCI Center for Cancer Research (CCR) trials from ClinicalTrials.gov and registers them in CTRP, completes trials registrations for new trials and amendments as requested for NCI - managed and/or sponsored trials Reviews documents, validates trial information, and abstract relevant administrative data following standard guidelines Performs necessary outreach to the cancer center community to obtain missing trial submission information Performs quality control checks to provide accurate, timely, and consistent clinical data abstractions Perform tasks related to individuals and organizations curation for the Clinical Trials Reporting Program (CTRP) Maintain the database of existing individuals and organizations Work closely with internal groups and external sites on data verification Identify and address data discrepancies in the PA application to ensure data standardization/harmonization across clinical trials within CTRP Ensure trial summary report TSR accuracy and consistency while adhering to time expectations Effectively communicate with trial submitters to address requests, questions, concerns and clearly document actions taken Contribute to process and application improvements including participation in revision of standard operating procedures SOPs and CTRP User Guides Handle special requests or other duties in support of CTRP, as assigned Train junior employees and participate in cancer center trainings Develop training material for cancer centers, and update the materials when necessary This position is located in Rockville, Maryland BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency. No experience required beyond the Bachelor's degree Ability to analyze multiple systems and information sources and provide accurate results. Ability to prioritize multiple projects and deadlines in a short period of time and communicate status of projects effectively. Ability to troubleshoot and appropriately report unexpected problems that may arise during the data abstraction of clinical trials Proficient with computer usage and Microsoft Office applications Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Minimum of two (2) years of experience in a pharmaceutical, biotechnology and/or clinical environment which includes medical and regulatory technical writing/editing Familiarity with areas of clinical trials, both interventional and non-interventional Familiarity with data reporting requirements and Cancer Center Support Grant reporting requirements Ability to work in a fast paced setting, both independently and within a team Ability to effectively incorporate diverse feedback from the user community into a high-quality document Ability to effectively provide CTRP overviews to CTRP Users and communicate follow up items to team Exceptional written and oral communication skills with expertise with grammar, syntax, and formatting Ability to mentor Junior personnel Must be detail oriented Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Bethesda, MD, USA
Sep 19, 2019
Full time
The Clinical Monitoring Research Program Directorate (CMRPD) is assisting the National Heart, Lung, and Blood Institute (NHLBI) to develop and implement a well-defined Program Management and Support Services (PMSS) framework and infrastructure that can quickly integrate project/program management and other support functions under a matrixed team concept, committing personnel and expertise from multiple organizations within the Institute. This PMSS will directly support major NHLBI initiatives and will allow for implementing robust project management processes and procedures across the Institute through training efforts, policy development, change management strategies, and other means as may be necessary. The NHLBI provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI stimulates basic discoveries about the causes of disease, enables the translation of basic discoveries into clinical practice, fosters training and mentoring of emerging scientists and physicians, and communicates research advances to the public. It creates and supports a robust, collaborative research infrastructure in partnership with private and public organizations, including academic institutions, industry, and other government agencies. The Institute collaborates with patients, families, health care professionals, scientists, professional societies, patient advocacy groups, community organizations, and the media to promote the application of research results and leverage resources to address public health needs. The NHLBI also collaborates with international organizations to help reduce the burden of heart, lung, and blood diseases worldwide. KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL Lead the planning and establishment of the PMSS and underlying program management infrastructure at the NHLBI by leveraging and developing policy, SOPs, tools, templates, and trainings Develop and recommend to NHLBI a robust Concept of Operations (CONOPS) plan for the PMSS that will be established organizationally under the technical direction of the NHLBI Office of the Executive Officer Identify initiative support requirements and establish matrixed program management support teams, with clear roles and responsibilities, that draw upon a diverse set of skills and capabilities from distinct organizations within the Institute and from external organizations Develop and maintain a unified monitoring and reporting framework across initiatives, such that cost, schedule, interdependencies, performance, and risk can be effectively managed at the initiative level and easily up channeled for Institute leadership input when appropriate Develop and maintain reporting framework that provides sufficient information for senior leadership to identify, integrate, and align synergistic activities of these initiatives as they evolve in a dynamic environment Develop and maintain tools, systems, documentation, standard templates, and other artifacts needed to accomplish the objectives of the PMSS, and to build out a robust infrastructure for the PMSS Implement robust project management practices and thinking among NHLBI staff through policy development, change management strategies, targeted training efforts, and other means as may be necessary subject to the approval of the NHLBI Provide recruiting support for candidates that meet unique blends of scientific and project management skill sets This position is located at NIH/NHLBI, Office of the Executive Offices, Building 31, Suite 5A48, 31 Center Drive, Bethesda, Maryland, 20892 BASIC QUALIFICATIONS Master's degree in Science, Business Management or related field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) (Additional qualifying experience may be substituted for the required education) Foreign degrees must be evaluated for U.S. equivalency In addition to educational requirements, a minimum of eight (8) years of operations management/program administration experience Minimum of five (5) years experience in a clinical management and/or a leadership role in a life sciences, pharmaceutical or biotechnology environment Experience leading and providing senior level program/project management for complex business including the integration of comprehensive activities Ability to independently manage and prioritize multiple complex projects at a director level Ability to effectively lead, manage, organize and interact with other members of senior management Ability to apply leadership and interpersonal skills by use of strategic thinking, team and project leadership, staff development and decision-making Ability to excel in fluid working environments and adapt to changing priorities Ability to adapt and perform under innovative business, project and funding mechanisms Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS PhD degree Project Management Certification Experience involving early translational, pre-clinical, and/or clinical research-related projects Familiarity and experience with federal government programs Ability to clearly communicate and collaborate across divisions and programs and with numerous external stakeholders Ability to attend meetings as a program liaison Ability to create and maintain business processes and write, interpret and implement various policies and procedures, ensuring smooth operations Detail-oriented with a proactive approach Proficiency with Microsoft software applications Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Rockville, MD, USA
Sep 19, 2019
Full time
Come work with the Frederick National Laboratory for Cancer Research (FNLCR) which is managed by Leidos Biomedical Research, Inc. for the National Cancer Institute. It is the only U.S. National Laboratory wholly focused on research, technology, and collaboration in the biomedical sciences - working to discover, to innovate, and to improve human health. The mission of the Biomedical Informatics and Data Science (BIDS) directorate within FNLCR is to leverage leading-edge data science, informatics and information technology skills and capabilities to provide the world-class tools and services to accelerate translation of biomedical data to scientific discoveries, medical treatments, and diagnostic and prevention innovations for cancer and AIDS patients. The BIDS Strategic and Data Science Initiatives Group has been established within the BIDS directorate to undertake key initiatives and establish new collaborations in computing and data science to address cancer challenges and accelerate cancer research. One such strategic and visible effort is the NCI-DOE collaboration setup to use large scale computing to advance the development of patient derived laboratory models of cancer, as well as improve understanding of existing treatments outside of clinical trials through the use of dynamic computer simulations and predictive models. KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL Senior Software Engineer Develop enterprise software for data sharing platforms. Implement new APIs and architectures Deliver capabilities to enable sharing of data and software (including AI models and molecular dynamics simulations) developed in NCI-DOE collaborations with the broader research community Perform design, development, integration and deployment using agreed upon standards and tools Participate in code reviews and sprint retrospectives Maintain high standards of software quality while delivering solutions on-time and within budget Identify and address technology challenges to develop robust, secure, and scalable products and solutions that meets or exceeds customer expectations Keep abreast of emerging trends and advances in data and metadata management BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency. In addition to the education requirements, five (5) years of software development experience, with at least 3 years in a production system 4 years of experience in the design, development and testing of enterprise applications with Java/J2EE Experience with Python Proficient in RDBMS e.g. Postgres, Oracle. Experienced in ORM frameworks e.g. Hibernate Experience with web UI libraries and frameworks e.g. JQuery, Ajax, Angular Familiarity with RESTful web services Experience with Source Control systems e.g., Github, SVN Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Possession of a Master's degree Familiarity with machine learning tools and frameworks e.g. MLFlow, TensorFlow.js Experience using model representation formats e.g. ONNX Knowledge of scientific workflows Experience with data management systems handling big data Familiarity with cloud technologies Expected Competencies: Ability to work with ease in a fast paced, agile environment Self-motivated and result-oriented, able to handle multiple projects efficiently Excellent communication and interpersonal skills Must be a team player
Frederick National Laboratory for Cancer Research Rockville, MD, USA
Sep 19, 2019
Full time
The vision of Biomedical Informatics and Data Science (BIDS) is to develop enterprise-level, consolidated information technology infrastructure that will provide exceptional IT capabilities to the National Cancer Institute (NCI) in support of basic, translational, and clinical cancer and AIDS research. The Biomedical Applications Development Center (BADC) is part of BIDS and is primarily involved in developing informatics system to support precision medicine initiatives. Specifically, BADC provides modern cloud architectures, computer science, informatics, bioinformatics, data warehousing, data science, and help desk support for the enterprise applications developed in support of precision medicine. KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL This career requires the successful candidate to use modern cloud technologies to create Star Schemas for data warehousing and relational data modeling to create 3rd normal form (3NF) OLTP databases for use in a MySQL and/or PostgresSQL environments, namely RedShift and Aurora. These schemas will be used to support the reporting needs of the Data Science and Bioinformatics teams in the creation of Pharmaceutical Reports, Genomic Reports, Trial Reports, and various other reports needed for the successful conduction of clinical trials. Further, strong knowledge of Extraction, Transformation and Loading (ETL) techniques will be required for the moving of data from the OLTP and OLAP schemas. BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college or university (according to CHEA) in a STEM field including Computer Science, Programming, Software Engineering, Mathematics, Database, or other Engineering Field is required. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency In addition to the educational requirements, a minimum of six (6) years of data management experience Strong programming/scripting skills with demonstrated experience Must be able to maintain a security clearance Familiarity with interactive databases and data validation Must be detail oriented with strong analytical skills and the ability to prioritize multiple tasks/projects Strong problem solving, planning, and organizational skills Ability to work effectively within a team configuration Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results Ability to create schemas using 3NF and Star Diagramming practices Proficient in SQL and another programming language PREFERRED QUALIFICATIONS Possession of a Masters' degree from an accredited college or university (according to CHEA) in the Life in a STEM field including Computer Science, Programming, Software Engineering, Mathematics, Database, or other Engineering Field is required. Experience with AWS Cloud technologies including RedShift and Aurora Proficient in Python Experience with clinical and genomic data Experience with cancer research data/projects Knowledge of statistical methods and analysis Other Clinical job experience Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Sep 15, 2019
Full time
The Laboratory Animal Sciences Program (LASP) provides exceptional quality animal care and technical support services for animal research performed at the National Cancer Institute at the Frederick National Laboratory for Cancer Research. LASP executes this mission by providing a broad spectrum of state-of-the-art technologies and services that are focused on the design, generation, characterization and application of genetically engineered and biological animal models of human disease, which are aimed at the development of targeted diagnostics and therapies. LASP contributes to advancing human health, developing new treatments, and improving existing treatments for cancer and other diseases while ensuring safe and humane treatment of animals. KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL Performing cultural and molecular based diagnostic procedures on a variety of laboratory animals and environmental samples for pathogen detection and diagnostic evaluation to ensure the health status of animals in animal facilities Design, perform, document, and report the results of a variety of microbiological and molecular biological procedures including culture, microscopic examination, nucleic acid isolation, PCR and real-time PCR/RT-PCR assays Performing necropsy of laboratory rodents, and the collection of blood, tissues/organs and other biological samples for diagnostic evaluation when needed BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency. In addition to educational requirements, a minimum of two (2) years related microbiological and molecular biology experience. Extensive experience with culture, nucleic acid isolation, PCR and real-time PCR techniques Ability to independently carry out experimental procedures and perform trouble shooting to ensure the timely completion of overall project Competent with computer operations and Microsoft Excel program Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Microbiological methods PCR, real-time PCR JOB HAZARDS OR REQUIREMENTS Candidate will be working with or have the potential for exposure to animal(s) and/or animal material(s) Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements Candidate will be working with or have the potential for exposure to Vaccinia virus, requiring medical clearance and immunizations in accordance with protocol requirements Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Sep 15, 2019
Full time
The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases. KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL Reporting to the Purification Manager, the Manufacturing Associate I will: Operate chromatography skids, tangential flow filtration skids, cGMP autoclaves, and basic laboratory equipment Perform chromatography resin packing in various sizes and types of chromatography column hardware Perform in-process sampling Perform operation and changeover of equipment Perform filter integrity testing Follow Standard Operation Procedures (SOP) Complete Batch Production Records under cGMP Document in detail, using Batch Production Records or laboratory notebooks, the processes and manufacturing steps taken during the procedures BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency No experience required beyond Bachelor's degree Ability to be gown certified Ability to lift up to 35 pounds This position may require working on 2nd or 3rd shifts and weekends as needed Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Working knowledge of cGMPs and computer-assisted manufacturing and production equipment Clean room and BL2 experience Skills/experience in processes and equipment associated with column chromatography techniques from small to pilot scale Experience in the operation of chromatography skids Experience in the operation of tangential flow filtration skids Experience in operation of UnicornTM software Experience in chromatography column packing/qualification JOB HAZARDS OR REQUIREMENTS Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Rockville, MD, USA
Sep 15, 2019
Full time
Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program's mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program Directorate (CMRPD)/Clinical Trials Reporting Office (CTRO) supports the NCI's Clinical Trials Reporting Program (CTRP), which maintains a database of information on NCI-supported clinical trials. The CTRO team creates and maintains clinical trial summary records in the CTRP database. These records serve the NCI for portfolio analysis purposes and they are the source for information used to support the cancer research grants review process. Some of the clinical trial information that the CTRO abstracts is fed to public clinical trial search websites including Cancer.gov and ClinicalTrials.gov. KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL Writes database queries to support CTRO reporting of performance metrics, data quality review, etc. Works closely with the CTRP applications and data science teams to keep up-to-date with changes to the database model and business rules Assists the customer and team with analyzing data in the CTRP database Gathers requirements and prepare reports as needed by the CTRO team in a timely fashion Communicates with external customers to facilitate report requests with the CTRP engineering team Collaborates with the CTRP engineering team to ensure routine reports are built into reporting applications Maintains the communications tracking application, troubleshoot problems, and manage user access Provides basic training to new users of the communications tracking application Facilitates any transitions to the use of new or upgraded applications or reporting systems Serves as a CTRO technical representative in application development discussions Contributes to process and application improvements including participation in revision of standard operating procedures and CTRP user guides Participates in user acceptance testing for any new design Assists the CTRO User Support Team as needed with triaging and responding to communications submitted to CTRO Handles special requests or other duties in support of CTRP This position is located in Rockville, Maryland BASIC QUALIFICATIONS Possession of an Associate's degree in biomedical science, bioinformatics, math or computer related field from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency. In addition to the educational requirements, a minimum of two (2) years progressively responsible job-related experience Proficient with computer usage and Microsoft Office applications Knowledge of the (EW) support and issue tracking system, or similar system(s) Ability to read and write SQL Programming Language Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Knowledge of Enterprise Wizard or ZenDesk communication/issue tracking applications, or similar system(s) Familiarity with clinical trials Experience querying biomedical data and generating graphs/reports Ability to analyze multiple systems and information sources and create accurate reports Experience working in a multi-functional team environment Ability to prioritize multiple projects and communicate status of projects effectively Knowledge of data quality assurance methods and best practices Exceptional written and verbal communication skills Ability to work in a fast paced setting, both independently and within a team Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Sep 13, 2019
Full time
The role of the Partnership Development Office (PDO) is to work with Frederick National Laboratory for Cancer Research (FNLCR) staff to assist in building multi-disciplinary partnerships with academic, FFRDCs, industrial, and private organizations. The goal of these partnerships is to accelerate treatment for cancer and AIDS by bridging the gap between late discovery and early development of diagnostics and therapeutics, developing cross-cutting technology platforms, and developing data standards. KEY ROLES/RESPONSIBILITIES The Partnership Alliance Manager at the PDO will be a key resource, with the primary responsibility of managing and coordinating partnership development and implementation processes, client relationships, and partnership projects. Key responsibilities for this position are: Provide comprehensive project management oversight (monitoring and reporting) of partnership project objectives, deliverables, milestones, and contractual obligation to ensure the success of partnership projects Conduct internal in-reach/workshops for FNLCR scientists. Provide cCRADA processing support Organize and participate in events and symposiums related to technology licensing and collaborations Provide business development and project management support for different initiatives at the Frederick National Laboratory for Cancer Research Serve as a key liaison and relationship coordinator between the FNLCR, the National Cancer Institute (NCI), and partner organizations BASIC QUALIFICATIONS Possession of a Bachelor's degree in a science or business-related field from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency In addition to the educational requirements, a minimum of five (5) years of progressively responsible job-related experience, including project management, business development, technology transfer, and customer relations Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Master's degree in Business or Ph.D. in science or engineering preferred Knowledge of partnership management and business development acumen Familiarity with advances in data/analytical sciences in research Familiarity with government business mechanisms Working knowledge of scientific principles related to the program, technology transfer, licensing, and intellectual property Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Sep 13, 2019
Full time
The Facilities Maintenance and Engineering (FME) Directorate is responsible for laboratory space, administrative space, infrastructure, campus landscape, planning, and design, and construction management at Frederick National Laboratory for Cancer Research. This position description does not represent a current opening but may be used to identify candidates with skills and experience for positions within Leidos Biomedical Research that frequently become available. Candidates who express an interest may be considered for future positions at Leidos Biomedical Research. KEY ROLES/RESPONSIBILITIES Monitoring projects' performance against budget baselines and established performance milestones Compiling and reviews budgets for FME using actual performance, previous budget figures, estimated revenue, expense reports, and other data sources to control funds and provide for proper financial administration Performing estimate at completion (EAC) analysis of all cost elements within a project taking into consideration contract commitments, expenditures to date, changes and potential trends Understanding the impact of indirect cost on project total cost Preparing financial plans, monitoring implementation of financial policies Extracting and developing monthly reports from the project finance and accounting system to track costs and budgets Analyzing cost and schedule information, identifying potential concerns, as well as corrective alternatives, and presenting recommendations to management Preparing regular and special-purpose reports Assisting the project team in the development and monitoring of a project's EAC and assessing the reasonableness of the EAC Serving as main point of contact for FME interface with the finance department and NCI regarding funding and financial matters Maintaining historical records, analyzing trends, establishing cost rates and personnel forecasts Analyzing quantitative project financial data and making recommendations to senior management Maintaining database(s) by entering, verifying, and backing up data to ensure integrity and completeness of financial data systems Updating contract commitments, reconciling and analyzing actual expenditures, monitoring trend status and maintaining continuity of tracking structure Recommending and interpreting budgetary policies and procedures, preparing comparative evaluation of actual costs against budgeted funds Developing creative reporting tools to communicate complex project sequencing and/or progress assessments Attending project meetings to provide current financial information and potential impacts to project budget or forecast Providing detailed performance metrics and analysis for senior management and NCI at established intervals BASIC QUALIFICATIONS Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency. In addition to the educational requirements, a minimum of five (5) years of related experience Experience in engineering and construction processes Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Experience in Maximo, Cost Point and SharePoint Experience in facilities maintenance AACE International Certification Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Sep 13, 2019
Full time
The Applied and Developmental Research Directorate (ADRD) provides clinical and biological monitoring, regulatory support, biospecimen processing and storage, assay development, and project management support to the National Cancer Institute (NCI) and National Institute of Allergy and Infectious Disease (NIAID) clinical programs including the Division of Cancer Treatment and Diagnosis (DCTD). DCTD facilitates pathways for unique molecules, diagnostic tests, and therapeutic interventions to clinical applications, including distinct molecular signatures for cancer, refined molecular assays, and state-of-the-art imaging techniques. The NCI Patient Derived Models Repository (PDMR) provides scientific and logistical support for all aspects of patient-derived model development including tissue and clinical data acquisition, model development, model quality control and quality assurance, and model distribution. KEY ROLES/RESPONSIBILITIES Manage cell line requests for the DCTD Tumor Repository ( ) Gather and disseminate information to principal investigators (PI's) on how to order cells Become familiar with the wording of the standard Material Transfer Agreement (MTA) so subtle changes can be identified Input and maintain data in an MTA database Use Freezerworks (material tracking program) to check on material and testing availability Assemble Shipment Summaries and work with a subcontractor to process orders Assemble Shipment Packages: MTA, detailed method of payment, tax exempt certificate, and shipment details Search private server to find and use historical data BASIC QUALIFICATIONS Possession of high school diploma or equivalent. Foreign degrees must be evaluated for U.S. equivalency In addition to educational requirements, a minimum of two (2) years of related experience including one (1) year at the level of Document Coordinator/Processor I. Ability to perform data entry, data retrieval, and data QA/QC across multiple platforms Knowledge of MS Word, MS Excel, and Adobe Acrobat Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS College entry level math skills Experience in quality assurance or control for technical documents, or similar Knowledge of Freezerworks or similar material tracking software Strong oral and written communication skills Ability to work independently while also coordinating work efforts with team members JOB HAZARDS OR REQUIREMENTS Candidate will be entering an animal facility or have the potential for exposure to animal allergens Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Sep 12, 2019
Full time
The Laboratory Animal Sciences Program (LASP) provides exceptional quality animal care and technical support services for animal research performed at the National Cancer Institute at the Frederick National Laboratory for Cancer Research. LASP executes this mission by providing a broad spectrum of state-of-the-art technologies and services that are focused on the design, generation, characterization and application of genetically engineered and biological animal models of human disease, which are aimed at the development of targeted diagnostics and therapies. LASP contributes to advancing human health, developing new treatments, and improving existing treatments for cancer and other diseases while ensuring safe and humane treatment of animals. KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL Feeding and housing laboratory animals General laboratory animal housekeeping Cage changing and sanitation Cleaning tasks associated with the upkeep of a research animal facility Ordering and stocking supplies Keeping simple records Utilizing computer skills for email, training, and basic data entry Operate automatic washing and cleaning equipment Collecting hair, fecal and blood samples for diagnostic testing Rotating holidays and weekends Work may involve the use of potentially hazardous material, including biological and chemical carcinogen or radiological materials or may be located in areas where such materials are used, require the use of personal protective equipment and adherence to strict safety protocol. BASIC QUALIFICATIONS Completion of the eighth grade In addition to educational requirements, a minimum of one (1) year of job-related animal care experience and ALAT certification or- two (2) years laboratory animal care experience. satisfactory completion of an internal competency assessment. Ability to handle a variety of laboratory animals Ability to keep simple records Ability to operate automatic washing and cleaning equipment Ability to lift to 40-50 lbs. and wear respiratory protective equipment if necessary Knowledge of routine tasks associated with general laboratory animal care Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Good organization/observational skills Desire to learn new tasks Computer/data entry Ability to work in a team environment JOB HAZARDS OR REQUIREMENTS Candidate will be entering an animal facility or have the potential for exposure to animal allergens Candidate will be working with or have the potential for exposure to animal(s) and/or animal material(s) Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements Candidate would be working with or have the potential for exposure to Toxoplasma gondii, requiring medical clearance and immunizations in accordance with protocol requirements Candidate will be working with or have the potential for exposure to Diphtheria toxin, requiring medical clearance and immunizations in accordance with protocol requirements Candidate is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance Candidate would be working in or have the potential for exposure to high noise levels for extended period of time. This may require a medical clearance and enrollment into the Hearing Conservation Program Candidate is subject to the following environmental conditions such as working outdoors, high humidity areas indoors, dampness and chilling, dry atmospheric conditions, etc. as part of the job Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Frederick National Laboratory for Cancer Research Frederick, MD, USA
Sep 12, 2019
Full time
The Laboratory Animal Sciences Program (LASP) provides exceptional quality animal care and technical support services for animal research performed at the National Cancer Institute at the Frederick National Laboratory for Cancer Research. LASP executes this mission by providing a broad spectrum of state-of-the-art technologies and services that are focused on the design, generation, characterization and application of genetically engineered and biological animal models of human disease, which are aimed at the development of targeted diagnostics and therapies. LASP contributes to advancing human health, developing new treatments, and improving existing treatments for cancer and other diseases while ensuring safe and humane treatment of animals. KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL Variety of routine tasks associated with the general laboratory animal care in biomedical research Feeding and housing laboratory animals General laboratory animal housekeeping Cleaning tasks associated with the upkeep of a research animal facility Ordering and stocking supplies Keeping simple records Utilizing computer skills for email, training, and basic data entry Operate automatic washing and cleaning equipment Work schedule may include weekend and holiday hours BASIC QUALIFICATIONS Requires an 8th grade education or higher Ability to keep basic records Ability to lift up to 50 lbs. and wear respiratory protective equipment as necessary Basic knowledge of computers Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Ability to handle laboratory animals Ability to multi-task Eagerness to learn new skills Excellent organization and observation skills JOB HAZARDS OR REQUIREMENTS Candidate will be entering an animal facility or have the potential for exposure to animal allergens Candidate will be working with or have the potential for exposure to animal(s) and/or animal material(s) Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements Candidate would be working with or have the potential for exposure to Toxoplasma gondii, requiring medical clearance and immunizations in accordance with protocol requirements. Candidate will be working with or have the potential for exposure to Diphtheria toxin, requiring medical clearance and immunizations in accordance with protocol requirements Candidate is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance Candidate would be working in or have the potential for exposure to high noise levels for extended period of time. This may require a medical clearance and enrollment into the Hearing Conservation Program. Candidate is subject to the following environmental conditions such as working outdoors, high humidity areas indoors, dampness and chilling, dry atmospheric conditions, etc. as part of the job. Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)