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<br><h4>Overview</h4><p>LMI seeks a Logistics Subject Matter Expert to support a CBP program management office in the National Capital Region (Washington, DC). Join our team of collaborative self-starters focused on delivering practical and efficient solutions to help our client keep U.S. borders safe and facilitate trade and travel. As part of our high-performing team, you will augment our vital work to provide “eyes and ears” technology to protect our nation.&nbsp;</p><p>LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.</p><p>LMI has been named a <strong>2024 #BestPlacestoWork</strong> in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!</p><h4>Responsibilities</h4><p>You will support life cycle management and sustainment for CBP’s portfolio of programs, projects, demonstrations, and other efforts. You will apply your skills in Integrated Logistics Support (ILS) principles to help establish policy, processes, and procedures that extend system lifecycles, require less support, and reduce overall life-cycle costs. In addition, you will provide ILS input in the development of requirements documentation for new systems and other key acquisition, engineering, and logistics artifacts supporting the acquisition and Operations and Support (O&amp;S) phases of an acquisition program.</p><p>Other duties include:</p><ul><li>Lead a team of LMI Logistics Analysts while collaborating with client’s internal/external customers.</li><li>Assist the government in the development and implementation of CBP enterprise life cycle logistics support policy (aligned with DHS MD 102-01 Appendix J, Logistics and Sustainment).</li><li>Experience advising clients on data best practices, methods, and use to generate better informed business and/or mission decisions.</li><li>Provide logistics planning and implementation support, to include:</li><ul><li>CBP’s Cost-Wise Readiness tenets implementation and execution support.</li><li>Independent Logistics Assessment support.</li><li>Lifecycle Logistics Management workforce development support.</li><li>Logistics and sustainment support for planned and deployed systems. </li><li>Asset management and training support.</li></ul><li>Review and provide feedback to CBP programs’ life cycle logistics support and ILS plans.</li><li>Provide input to program contract requirements for life-cycle support, Test and Evaluation Master Plans (TEMPS), Life Cycle Cost Estimates (LCCE), and Project Management Plans (PMP).</li></ul><h4>Qualifications</h4><ul><li>15+ years of major system logistics experience.</li><li>Bachelor's degree required.&nbsp; Master's degree preferred.</li><li>Previous experience with program or lifecycle logistics management at DoD, DHS, or other civilian agency with demonstrated acquisition and lifecycle management experience with a major weapon system, border enforcement, or other federal civilian acquisition/capital investment program.</li><li>DHS or DAWIA logistics Lifecycle Logistics Level 3 certification a plus.</li><li>Ability to pass a government background investigation, including financial, criminal, residential, educational, foreign affiliation, prohibited substance use, and employment verifications. Only U.S. citizens are eligible for a suitability determination.</li><li>Active U.S. Customs and Border Protection (CBP) background investigation (BI) preferred. </li><li>Proficiency in Microsoft Word, Excel, Outlook, PowerPoint, and SharePoint.</li><li>Strong leadership qualities.</li><li>Ability to communicate clearly with a variety of stakeholders.</li><li>Ability to effectively solve problems.</li><li>Strong communication skills, both oral and written.</li><li>A true team player who maintains a positive attitude in a dynamic environment.</li></ul><p>Targeted Salary Range: $131,000-$190,000</p><p><em><strong>Disclaimer:</strong></em></p><p>The salary range displayed represents the typical salary range for this position and is not a guarantee of compensation. Individual salaries are determined by various factors including, but not limited to location, internal equity, business considerations, client contract requirements, and candidate qualifications, such as education, experience, skills, and security clearances.</p><p>#LI-SH1</p><h4><br>LMI is an Equal Opportunity Employer. LMI is committed to the fair treatment of all and to our policy of providing applicants and employees with equal employment opportunities. LMI recruits, hires, trains, and promotes people without regard to   race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, disability, age, protected veteran status, citizenship status, genetic information, or any other characteristic protected by applicable federal, state, or local law. If you are a person with a disability needing assistance with the application process, please contact <a href="mailto:accommodations@lmi.org" target="_blank">accommodations@lmi.org</a><br>Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.<br><br><b>Need help finding the right job?</b><br></h4>We can recommend jobs specifically for you!Click here to get started.<br>

LMI Consulting, LLC

Logistics Subject Matter Expert

<br><h4>Overview</h4><p>LMI is seeking a skilled Data Solutions Specialist. Successful Data Solutions Specialists demonstrate competency in project execution, leadership critical thinking, relationship management, and solving complex challenges while upholding the highest standard of ethical behavior.</p><p>At LMI, we’re reimagining the path from insight to outcome at The New Speed of Possible™. Combining a legacy of over 60 years of federal expertise with our innovation ecosystem, we minimize time to value and accelerate mission success. We energize the brightest minds with emerging technologies to inspire creative solutioning and push the boundaries of capability. LMI advances the pace of progress, enabling our customers to thrive while adapting to evolving mission needs.&nbsp;</p><h4>Responsibilities</h4><p>Providing direct support to the Department of Veteran's Affairs Offices of Metal Health and Suicide Prevention, this Data Solutions Specialist will:</p><ul><li>develop intuitive dashboards and data visualization products using Microsoft PowerApps and Microsoft Power BI for data and metrics reporting using administrative medical records data, other VA administrative data, and curated data sets within the VA Suicide Prevention Program Office;</li><li>develop a user-friendly and visually appealing reporting interface in Microsoft Power BI;</li><li>work with other Power BI Developers to build and design a high-profile reporting dashboard for our VA clients;</li><li>deploy and maintain dashboards and linkages to other dashboards and databases;</li><li>provide ongoing support and management of the dashboard once completed;</li><li>design efficient databases and workbooks needed to support program-specific dashboards;</li><li>demonstrate strong technical and computational skills - engineering, physics, mathematics,&nbsp; coupled with&nbsp; the ability&nbsp; to code design, develop, and deploy sophisticated applications using advanced unstructured and semi-structured data analysis techniques and utilizing high-performance computing environments;</li><li>utilize advance tools and computational skills to interpret, connect, predict and make discoveries in complex data and deliver recommendations for business and analytic decisions, ideally SQL;</li><li>support business decisions with ad hoc analysis;</li><li>think strategically about how to publish data visualizations and present analytic results for VHA executive leadership and other stakeholders;</li><li>develop a familiarity with machine learning algorithms and advanced statistical methods, such as regression, clustering, decision trees, exploratory data analysis methodology, simulation, scenario analysis, modeling, and neural networks;</li><li>use critical thinking skills to assess how machine learning capabilities can best be applied to complex business situations;</li><li>serve as a technical/domain expert providing direction, interpretation, and alternatives&nbsp;to advise, consult, and recommend solutions;</li><li>collect, study, and analyze data to inform and determine suggested courses of action;</li><li>perform studies such as analysis of alternatives and return on investment;</li><li>prepare documentation including reports, papers, and presentations to communicate key Government owned data to internal and external audiences;</li><li>maintains knowledge and apply advanced technical principles, theories, and concepts and;</li><li>create data flow maps, process guides, and other support documents that describe collection, archiving, management, and retrieval processes for program evaluation data.</li></ul><h4>Qualifications</h4><p><strong>MINIMUM:</strong></p><ul><li>Bachelor’s Degree in science, technology, engineering, mathematics, computer science, economics, business, healthcare administation or a related discipline.</li><li>3+ years of experience developing dashboards using Microsoft Power BI or other data visualization tools.</li><li>3+ years of experience using SQL and other relational databases.</li><li>Knowledge of best practices in data visualization and business intelligence software, including recent versions of Microsoft PowerApps and Microsoft Power BI.</li><li>Experience with modeling and cleansing data for use within Microsoft Power BI reporting and dashboards.</li><li>Experience developing content for and delivering training to others on the use of Microsoft Power BI or a similar business intelligence software.</li><li>Ability to design and influence data architectures to reflect how users will access and analyze data.</li><li>Excellent communication skills and proven ability to work with business customers and technical teams.</li><li>Ability to provide exceptional client service, research and resolve issues, and demonstrated commitment to continuous learning.</li><li>Ability to work effectively in a team environment with all levels of client personnel in various industries.</li><li>This position requires a favorable Goverment background check and ability to obtain access to VA systems and data. You must be a US citizen.</li></ul><p><strong>DESIRED SKILLS:</strong></p><ul><li>Master’s degree in science, technology, engineering, mathematics, computer science, economics, business, healthcare administation or a related discipline.</li><li>Knowledge of statistics and experience using statistical analysis software (SAS) to analyze data and create statistical models.</li><li>Previous VA/VHA experience.</li><li>Previous experience developing analytics and visualizations for the program evaluation of public health or government initatives.&nbsp;</li></ul><h4><br>LMI is an Equal Opportunity Employer. LMI is committed to the fair treatment of all and to our policy of providing applicants and employees with equal employment opportunities. LMI recruits, hires, trains, and promotes people without regard to   race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, disability, age, protected veteran status, citizenship status, genetic information, or any other characteristic protected by applicable federal, state, or local law. If you are a person with a disability needing assistance with the application process, please contact <a href="mailto:accommodations@lmi.org" target="_blank">accommodations@lmi.org</a><br>Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.<br><br><b>Need help finding the right job?</b><br></h4>We can recommend jobs specifically for you!Click here to get started.<br>

Data Solutions Specialist

<br><h4>Overview</h4><p>LMI is seeking a<strong>&nbsp;Senior Statistics SME&nbsp;</strong>to support the Biomedical Advanced Research and Development Authority (BARDA). <strong>This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></p><p>The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, software, Assay chemistry, microbiology, virology, immunology.</p><p>LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.</p><p>LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!</p><h4>Responsibilities</h4><ul><li>Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.</li><li>Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.</li><li>Participate as subject matter experts on Program Coordination Teams (PCTs).</li><li>Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed.</li><li>Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.</li><li>Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.</li><li>Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.</li><li>Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.</li><li>Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.</li><li>Provide recommendations for project development level portfolio management and oversight as required.</li><li>Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.</li><li>Provide subject matter expertise in innovative statistical thinking and methods to help drive the enhanced quantitative Medical Countermeasures development paradigm within BARDA.</li><li>Standardize statistical processes and methodologies across therapeutic areas.</li><li>Provide support to BARDA’s development networks guiding and monitoring sponsored research with Contract Research Organizations (CROs).</li><li>Supervise less experienced Statistics Subject Matter Experts.</li><li>Serve as the primary interface with BARDA and Industry Senior Leadership on statistics matters.</li><li>Coordinate with program managers, scientists, and other subject matter experts as required.</li><li>Participate in the design, analysis, and reporting of research studies.</li><li>Provides consultation to investigators and researchers on experimental design, and statistical research approaches, requirements, and scientific standard.</li><li>Work with investigators to formalize analysis plans and reporting specifications.</li><li>Advise BARDA leadership and industry partners as to the choice of statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.</li><li>Plan and document computer data file structure</li><li>Develop, program, manage, and maintains complex statistical databases.</li><li>Performs or supervises data entry.</li><li>Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data to derive useful information for research data.</li><li>Advise and assist in the development of inferences and conclusions, as appropriate.</li><li>Develop enhancements to statistical software, as appropriate, by programming new techniques; maintains knowledge of current and emerging trends in statistical analysis methodology.</li><li>Prepare a variety of comprehensive statistical reports according to presentation requirements.</li><li>Participates in manuscript preparation to include preparation of data summaries and statistical results for publication.</li><li>Provide program and policy support for clinical evidence and human subject protection, conduct epidemiological or real-world evidence analyses, facilitate collaboration and outreach with hospitals and other external stakeholders, or support the assessment and development of data structures and other methods for rapid data collection and analysis.</li><li>Provide expert consultation and support to the BARDA stakeholders, as needed.</li><li>Provide statistical expert scientific, technical, and regulatory support and direction to colleagues in response to questions related to the access and use of clinical evidence.</li><li>Facilitate discussions with internal and external stakeholders to facilitate rapid collaboration.</li><li>Develop and conduct assessments on the impact of emerging laws, regulations, and standards for medical device and radiological health product manufacturers, importers, and facilities that use these products. May also oversee, monitor, and evaluate international standards.</li><li>Assesses emerging, complex, and precedent-setting issues that impact programs, analysis, and policies.</li><li>Review relevant data for accuracy, precision, and reliability and makes recommendation on whether the data provided are sufficient for analysis.</li><li>Review program, policy, and analysis protocols and develop solutions for approaches to testing, analysis, program, or policy support.</li><li>Develop strategies for improving one or more of the following: clinical or real-world evidence studies, epidemiologic analysis, data infrastructure methodologies, opportunities to work with other center officials to assess public safety signals, or medical device partnership opportunities.</li><li>Write and evaluate strategies, guidance documents, guidelines, and standards to improve evaluation, analysis, or program execution. Conduct discussions with industry engineers, scientists, and management officials.</li></ul><h4>Qualifications</h4><ul><li>Minimum of fifteen (15) years of relevant industry experience</li><li>Application of advance degree(s) in statistics or comparable quantitative field with a minimum of 10 (ten) years’ experience specifically related to the development of medical countermeasures against chemical, biological, radiological, and nuclear threat agents.</li><li>Strong statistical programming experience in SAS, R and/or python and advanced experience in data analytic platforms including MS Excel, JMP, etc.</li><li>Possess a wide range of development expertise in all aspects of medical countermeasure development and developing and applying animal models and appropriate&nbsp;<em>in vitro</em>&nbsp;assays.</li><li>Previous training the conducting studies in accordance with GLP regulations</li><li><strong>Ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></li></ul><h4><br>LMI is an Equal Opportunity Employer. LMI is committed to the fair treatment of all and to our policy of providing applicants and employees with equal employment opportunities. LMI recruits, hires, trains, and promotes people without regard to   race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, disability, age, protected veteran status, citizenship status, genetic information, or any other characteristic protected by applicable federal, state, or local law. If you are a person with a disability needing assistance with the application process, please contact <a href="mailto:accommodations@lmi.org" target="_blank">accommodations@lmi.org</a><br>Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.<br><br><b>Need help finding the right job?</b><br></h4>We can recommend jobs specifically for you!Click here to get started.<br>

Senior Statistics SME

<br><h4>Overview</h4><p>LMI is seeking a <strong>Senior Reg Ops Specialist SME </strong>to support the Biomedical Advanced Research and Development Authority (BARDA). <strong>This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></p><p>The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, software, Assay chemistry, microbiology, virology, immunology.</p><p>LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.</p><p>LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!</p><h4>Responsibilities</h4><ul><li>Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.</li><li>Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.</li><li>Participate as subject matter experts on Program Coordination Teams (PCTs).</li><li>Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed.</li><li>Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.</li><li>Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.</li><li>Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.</li><li>Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.</li><li>Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.</li><li>Provide recommendations for project development level portfolio management and oversight as required.</li><li>Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.</li><li>Follow FDA submission requirements in consideration of BARDA Program Divisions and the regulatory operational requirements of BARDA core services including clinical, nonclinical, and manufacturing network services.</li><li>Provide subject matter expertise for the management, design, publishing, review, submission, and archive of eCTD submissions, including amendments and original filing.</li><li>Coordinate publishing and submitting of all electronic dossiers and documents to regulatory authorities and/or clients.</li><li>Liaise with Regulatory Affairs Project Managers, and CROs directly, as necessary, to coordinate submission timelines and technical specifications and for client eCTD reviews.</li></ul><h4>Qualifications</h4><ul><li>Recognized Regulatory Operations expert with a bachelor’s or equivalent degree</li><li>Minimum of fifteen (15) years progressive experience in leading regulatory operational activities supporting drug, biologic, and device development regulated by the Food and Drug Administration (FDA)</li><li>Expert knowledge of FDA submission types and management of FDA submissions compliant with the eCTD specifications</li><li>Experience with electronic publishing software and advanced PDF processing tools</li><li>Expert knowledge of FDA and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) content requirements for CTD dossiers</li><li>Knowledge of and experience in document-level formatting and publishing</li><li>Understanding of the eCTD structure as well as US publishing guidance’s and ICH specifications for electronic publishing</li><li>Superior competency in MS Word</li><li>Experience with Accenture Starting Point</li><li>Preferred: Superior competency in Adobe Acrobat and ISIToolbox™ and/or other PDF toolset(s)</li><li>Ability to build XML documents using Lorenz or similar publishing software</li><li>Ability to self-train in areas that are not part of the routine processing for eCTD Submissions (i.e., CSR publishing, PEUA, EUAs)</li><li><strong>Ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></li></ul><h4><br>LMI is an Equal Opportunity Employer. LMI is committed to the fair treatment of all and to our policy of providing applicants and employees with equal employment opportunities. LMI recruits, hires, trains, and promotes people without regard to   race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, disability, age, protected veteran status, citizenship status, genetic information, or any other characteristic protected by applicable federal, state, or local law. If you are a person with a disability needing assistance with the application process, please contact <a href="mailto:accommodations@lmi.org" target="_blank">accommodations@lmi.org</a><br>Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.<br><br><b>Need help finding the right job?</b><br></h4>We can recommend jobs specifically for you!Click here to get started.<br>

Senior Reg Ops Specialist SME

<br><h4>Overview</h4><p>LMI is seeking a <strong>Senior Radiological/Nuclear SME&nbsp;</strong>to support the Biomedical Advanced Research and Development Authority (BARDA). <strong>This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></p><p>The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, software, Assay chemistry, microbiology, virology, immunology.</p><p>LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.</p><p>LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!</p><h4>Responsibilities</h4><ul><li>Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.</li><li>Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.</li><li>Participate as subject matter experts on Program Coordination Teams (PCTs).</li><li>Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed.</li><li>Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.</li><li>Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.</li><li>Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.</li><li>Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.</li><li>Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.</li><li>Provide recommendations for project development level portfolio management and oversight as required.</li><li>Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.</li><li>Provides guidance to less experienced staff, reviews the work of others, authoritatively contributes to multi-functional analytic teams, and maintains currency in understanding relevant nuclear technologies, trends, and procedures.</li><li>Devise, evaluate, and recommend new methodologies and analytical tools that are under development. </li><li>Develops and manages programs within current and planned BARDA radiological/nuclear medical countermeasure advanced development and acquisition contracts. </li><li>Coordinate with program managers, scientists, and other subject matter experts as required. </li><li>Routinely provide defense planners and operators with timely and accurate characterizations of adversary nuclear and strategic threats, WMD programs, and weapons-related S&amp;T developments. </li><li>Generate recommendations in the form of technical briefings, reports, and other analytic documents. </li><li>Collaborate with the Intelligence Community, Defense Department, national labs, and academia to address nuclear- and radiological-related threat issues.</li></ul><h4>Qualifications</h4><ul><li>PhD in nuclear engineering, physics, or closely related subject area</li><li>15+ years of experience with intelligence analysis, including employing multi-INT databases to develop analytic assessments and briefings</li><li>Experience in development of medical countermeasures, including diagnostics and devices, and vaccines and therapeutics</li><li>Deliverables would include work products related to the development and management of programs within current and planned BARDA radiological/nuclear medical countermeasure advanced development and acquisition contracts</li><li>Demonstrated knowledge of state nuclear programs, trends, and technologies, strategic weapons developments, WMD, and/or counterproliferation</li><li>Practical understanding of the technical requirements – both established and improvised – necessary to weaponize nuclear and/or radiological materials</li><li>A working familiarity with global nuclear energy-related programs, technologies, and initiatives</li><li>Understanding of global technology control, arms-control, and nonproliferation efforts associated with nuclear and strategic weapons (CTBT, FMCT, New START). Experience characterizing and assessing consequence management variables associated with nuclear weapons use and radiologically contaminated environments</li><li>Ability to communicate complex analyses at a level comprehensible to laymen and senior-level government representatives</li><li>Ability to clearly express in writing technical analysis results and program characterizations</li><li><strong>Ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></li></ul><h4><br>LMI is an Equal Opportunity Employer. LMI is committed to the fair treatment of all and to our policy of providing applicants and employees with equal employment opportunities. LMI recruits, hires, trains, and promotes people without regard to   race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, disability, age, protected veteran status, citizenship status, genetic information, or any other characteristic protected by applicable federal, state, or local law. If you are a person with a disability needing assistance with the application process, please contact <a href="mailto:accommodations@lmi.org" target="_blank">accommodations@lmi.org</a><br>Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.<br><br><b>Need help finding the right job?</b><br></h4>We can recommend jobs specifically for you!Click here to get started.<br>

Senior Radiological/Nuclear SME

<br><h4>Overview</h4><p>LMI is seeking a <strong>Medical Diagnostics SME&nbsp;</strong>to support the Biomedical Advanced Research and Development Authority (BARDA). The Medical Diagnostics SME will produce deliverables that include work products related to the evaluation and management of development, validation and manufacturing of medical device systems, reagents, and devices, including diagnostics that leverage pathogen and host information and therapeutic devices. <strong>This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></p><p>The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, software, Assay chemistry, microbiology, virology, immunology.</p><p>LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.</p><p>LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!</p><h4>Responsibilities</h4><ul><li>Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.</li><li>Serve as the primary interface with BARDA and industry senior leadership on medical diagnostics matters.</li><li>Provide strategic and technical direction to BARDA’s efforts to develop innovative treatments, diagnostic devices, and preventive measures that address threats posed by infectious diseases.</li><li>Serve as a reliable resource of technical counsel to BARDA and to companies that receive BARDA funding.</li><li>Coordinate with program managers, scientists, and other subject matter experts as required.</li><li>Provide an interface between the government, operational staff, and BARDA’s industry partners.</li><li>Apply an extraordinary degree of ingenuity, creativity and resourcefulness in the development, application, evaluation and development of advanced technologies, scientific principles, theories, and concepts to ensure the appropriate development of medical countermeasures against infectious agents.</li><li>Responsible for technical problem solving, data analyses, documentation of procedures and results, performing audits, and writing progress and final reports about medical countermeasures that address infectious diseases.</li><li>Serve as scientific and technical representative to the Contracting Officer (CO) and Technical Project Officer (PO) concerning the evaluation and development of medical diagnostics against infectious diseases.</li><li>Assess and monitor the risks associated with clinical development of medical diagnostics against infectious diseases.</li><li>Render technical opinions to the PO/CO.</li><li>Review for technical correctness and give expert analysis regarding documents generated by BARDA contractors and federal employees.</li><li>Actively participate in meetings with federal and contractor employees to obtain and evaluate project status and progress against contract milestones.</li><li>Perform site visits/audits with PO/CO (or designated representative) to contractor facilities, and/or facilities of subcontractors, to verify compliance with contract requirements.</li><li>Inform PO/CO of any increase/decrease in risk to success of the project and generate contingency risk reduction plans.</li><li>Assist in contract negotiations on technical matters, as requested.</li><li>Use extensive technical and industry knowledge to provide insight and technical counsel concerning BARDA’s strategic position within the community developing infectious disease medical countermeasures.</li><li>Independently perform activities consistent with established organizational practices, precedents, policies, and strategic objectives set forth by BARDA management.</li><li>Perform analytical, interpretive, evaluative and/or constructive thinking. Where appropriate or required, develop new methods and processes.</li><li>Make use of critical human relations skills to understand, select, develop, lead, motivate, and educate others both internal and to create teaming partnerships.</li><li>Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.</li><li>Participate as subject matter experts on Program Coordination Teams (PCTs)</li><li>Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.</li><li>Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.</li><li>Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.</li><li>Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work. Make suggestions on ways to improve those statements of work.</li><li>Experience distilling complex information into informative and concise summaries, including</li><li>Provide risk/benefit analyses and balanced recommendations.</li><li>Participate and aid in strategic discussions, working with USG, inbuilding new program areas in alignment with BARDA’s mission space.</li><li>Provide recommendations for project development level portfolio management and oversight as required.</li><li>Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.</li></ul><h4>Qualifications</h4><ul><li>Minimum of ten (10) years of relevant industry experience.</li><li>PhD in appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or Masters or Bachelors (with commensurate industry experience) of science in a physical science field (engineering, physics, computer science, or similar scientific specialization)</li><li>Commercial experience developing or manufacturing molecular or immunoassay diagnostic components or systems.</li><li><strong>Ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></li></ul><h4><br>LMI is an Equal Opportunity Employer. LMI is committed to the fair treatment of all and to our policy of providing applicants and employees with equal employment opportunities. LMI recruits, hires, trains, and promotes people without regard to   race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, disability, age, protected veteran status, citizenship status, genetic information, or any other characteristic protected by applicable federal, state, or local law. If you are a person with a disability needing assistance with the application process, please contact <a href="mailto:accommodations@lmi.org" target="_blank">accommodations@lmi.org</a><br>Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.<br><br><b>Need help finding the right job?</b><br></h4>We can recommend jobs specifically for you!Click here to get started.<br>

Medical Diagnostics SME

<br><h4>Overview</h4><p>LMI is seeking a <strong>Senior Nonclinical Models SME&nbsp;</strong>to support the Biomedical Advanced Research and Development Authority (BARDA). <strong>This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></p><p>The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, software, Assay chemistry, microbiology, virology, immunology.</p><p>LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.</p><p>LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!</p><h4>Responsibilities</h4><ul><li>Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.</li><li>Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.</li><li>Participate as subject matter experts on Program Coordination Teams (PCTs).</li><li>Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed.</li><li>Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.</li><li>Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.</li><li>Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.</li><li>Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.</li><li>Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.</li><li>Provide recommendations for project development level portfolio management and oversight as required.</li><li>Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.</li><li>Apply expert ability to deliver work products related to the development and management of programs within current and planned BARDA nonclinical contracts and task orders. </li><li>Provide nonclinical development subject matter expertise support throughout various programs within BARDA for MCM development. </li><li>Provide subject matter expertise in developing models to support U.S. FDA approval or licensure of MCMs for biological, chemical, and/or radiological/nuclear threats (e.g., Animal Rule pathway). </li><li>Coordinate with program managers, scientists, and other subject matter experts as required. </li><li>Provide subject matter expertise in conducting in vivo studies that demonstrate drug efficacy in animals expected to react with a response predictive of humans preferred to include the application of bioanalytical assays.</li><li>Provide support to BARDA’s nonclinical development networks guiding and monitoring sponsored research with Contract Research Organizations (CROs).</li><li>Analyze the need for improved or standardized animal models for BARDA’s priority pathogens. Work with staff to draft and launch tenders to client’s animal model network to address those needs. </li><li>Review and advise on non-clinical plans relating to animal models for safety, immunogenicity, and efficacy for BARDA’s partners’ candidate vaccines including attending joint client project team meetings. </li><li>Serve as expert and advisor for review of applications for funding through calls for proposals for vaccine development and contribute to the due diligence process. </li><li>Work with Project leaders for enabling science and/or preclinical leads for vaccine projects as needed. </li><li>Serve as one of the experts in the evaluation of non-clinical data across the BARDA’s portfolio. </li></ul><h4>Qualifications</h4><ul><li>Doctoral degree(s) in biology or similar field(s) with commensurate experience(s) in nonclinical development addressing bacterial and viral biothreat indications and toxins</li><li>Minimum of ten (10) years of relevant industry or commensurate professional experience</li><li>Experience in non-clinical study design, study execution, data interpretation and reporting with an understanding of all types of non-clinical studies and how this data fits into overall vaccine development, regulatory submissions, and licensure</li><li>Strong expertise in animal models, animal ethics policies, experience with US FDA Animal Rule, non-clinical immunology, correlates of protection, mode of action and safety; experience with vaccine development for broad protection against a pathogen family is desirable</li><li>Experience working in high-containment (BSL3/4) laboratories or facilities is desirable but not mandatory</li><li>Experience in working in collaborative R&amp;D projects, preferably across sectors (academic, private sector, public and private funders)</li><li>Established reputation as a subject matter expert as evidenced by peer reviewed publications and membership in professional associations is preferred</li><li><strong>Ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></li></ul><h4><br>LMI is an Equal Opportunity Employer. LMI is committed to the fair treatment of all and to our policy of providing applicants and employees with equal employment opportunities. LMI recruits, hires, trains, and promotes people without regard to   race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, disability, age, protected veteran status, citizenship status, genetic information, or any other characteristic protected by applicable federal, state, or local law. If you are a person with a disability needing assistance with the application process, please contact <a href="mailto:accommodations@lmi.org" target="_blank">accommodations@lmi.org</a><br>Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.<br><br><b>Need help finding the right job?</b><br></h4>We can recommend jobs specifically for you!Click here to get started.<br>

Senior Nonclinical Models SME

<br><h4>Overview</h4><p>LMI is seeking a <strong>Senior Regulatory Affairs SME&nbsp;</strong>to support the Biomedical Advanced Research and Development Authority (BARDA). <strong>This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></p><p>The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, software, Assay chemistry, microbiology, virology, immunology.</p><p>LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.</p><p>LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!</p><h4>Responsibilities</h4><ul><li>Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.</li><li>Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.</li><li>Participate as subject matter experts on Program Coordination Teams (PCTs).</li><li>Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed.</li><li>Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.</li><li>Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.</li><li>Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.</li><li>Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.</li><li>Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.</li><li>Provide recommendations for project development level portfolio management and oversight as required.</li><li>Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.</li><li>Serve as the primary interface with BARDA, industry and FDA senior leadership on regulatory affairs matters.</li><li>Supervise less experienced Regulatory Affairs Analysts.</li><li>Provide subject matter expertise in regulatory affairs supporting Medical Countermeasures (MCM) development pathways against potential public health threats, to include natural occurring epidemic threats such as influenza as well as chemical, biological, radiological, and nuclear threats. These technologies/products cross the gamut of vaccines, drugs, and devices.</li><li>Coordinate with program managers, scientists, and other subject matter experts as required.</li><li>Strategize innovative regulatory approaches to MCM development against emerging threats.</li><li>Advise regulatory and BARDA senior leadership on critical programmatic and project level regulatory challenges.</li><li>Provide training and advisement to BARDA staff on regulations, authoring regulatory documents, and interactions with regulatory authorities.</li><li>Serve as a Regulatory Affairs Subject Matter Expert for multiple programs and projects involving development and manufacturing of vaccines and other countermeasures for influenza and emerging infectious diseases.</li><li>Provide scientific/technical/program management advice for assigned programs and projects and work with the Government/Contractor Project Team to implement Regulatory plans for assigned projects.</li><li>Development of methodologies and procedures particular to CBER vaccine &amp; biologics products</li><li>Development and management of regulated studies.</li><li>Oversee validation and operation of cGMP manufacturing facilities for vaccines and biologics.</li><li>Assist in the compliance with contract requirements, federal regulations, and guidelines.</li><li>Provide conceptual ideas and insights for preparedness and response to emerging infectious diseases.</li><li>Prepare draft Statements of Work (SOW) for upcoming Requests for Proposals (RFP) and support technical and cost evaluation for white papers/proposals.</li><li>Support contract initiation/negotiation efforts. Participate in contract kick-off and ongoing meetings at supported company sites.</li><li>Draft meeting minutes, trip reports, and technical assessments and recommendations on the Regulatory aspects of BARDA-contractor interactions.</li><li>Review and comment on supported industry partner regulatory strategy, as assigned.</li><li>Review supported industry partner submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc.</li><li>Monitor supported industry partner project timelines for FDA submission.</li><li>Participate or act as regulatory representative on various cross-functional teams, as assigned.</li><li>Participate or lead regulatory interactions with FDA, as assigned.</li><li>Maintain knowledge on the US competitive landscape, regulatory environment, regulations, and guidance.</li><li>Attend and participate in industry conferences on BARDA’s behalf.</li><li>Provide Regulatory Research and Intelligence support for team as assigned.</li></ul><h4>Qualifications</h4><ul><li>Minimum of fifteen (15) years of relevant industry experience at senior regulatory affairs positions in the pharmaceutical industry</li><li>Application of master’s degree or higher in biology, microbiology, chemistry, toxicology, or pharmacy with commensurate experience</li><li>Experience in FDA engagement and development of regulatory documents</li><li>Deliverables would include work products related to the development and management of regulatory affairs strategic planning and guidance within current and planned BARDA vaccine, therapeutic, and/or device/diagnostic advanced development and acquisition contracts</li><li><strong>Ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></li></ul><h4><br>LMI is an Equal Opportunity Employer. LMI is committed to the fair treatment of all and to our policy of providing applicants and employees with equal employment opportunities. LMI recruits, hires, trains, and promotes people without regard to   race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, disability, age, protected veteran status, citizenship status, genetic information, or any other characteristic protected by applicable federal, state, or local law. If you are a person with a disability needing assistance with the application process, please contact <a href="mailto:accommodations@lmi.org" target="_blank">accommodations@lmi.org</a><br>Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.<br><br><b>Need help finding the right job?</b><br></h4>We can recommend jobs specifically for you!Click here to get started.<br>

Senior Regulatory Affairs SME

<br><h4>Overview</h4><p>LMI is seeking a <strong>Senior Chemical SME&nbsp;</strong>to support the Biomedical Advanced Research and Development Authority (BARDA). <strong>This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></p><p>The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, software, Assay chemistry, microbiology, virology, immunology.</p><p>LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.</p><p>LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!</p><h4>Responsibilities</h4><ul><li>Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.</li><li>Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.</li><li>Participate as subject matter experts on Program Coordination Teams (PCTs).</li><li>Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed.</li><li>Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.</li><li>Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.</li><li>Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.</li><li>Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.</li><li>Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.</li><li>Provide recommendations for project development level portfolio management and oversight as required.</li><li>Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.</li><li>Provide subject matter expertise in fields relevant to the Homeland Security Enterprise, including chemical and biological subject areas.</li><li>Monitor project performance and reviewing deliverables to ensure technical, programmatic, and financial goals and objectives are met and identify possible program risks.</li><li>Assist with planning technology transitions to the respective operational customer.</li><li>Attend meetings, workshops, conferences, and program reviews at the direction of the program or project manager to provide programmatic and technical review, record meeting minutes, and contribute to the program management dialogue with performers.</li><li>Support the identification, assessment, evaluation, and testing of existing and emerging technologies, systems, and capabilities, including coordination with related government, academic, and industry programs; attend meetings and symposia; coordinate meetings and programs reviews; and support program advocacy including development and production of presentation materials.</li><li>Expert ability to deliver work products related to the development and management of programs within current and planned BARDA chemical threat medical countermeasures advanced development and acquisition contracts.</li><li>Provide guidance to less experienced staff, reviews the work of others, authoritatively contribute to multi-functional analytic teams, and maintain currency in understanding relevant WMD technologies, trends, and procedures.</li><li>Coordinate with program managers, scientists, and other subject matter experts as required.</li><li>Collaborate with the Intelligence Community, Defense Department, national labs, and academia to address chemical and biochemical threat issues.</li><li>Perform assessments and projections as part of analysis process.</li><li>Develop technical reports and briefings, project deliverables, monthly status reports and other finished products.</li></ul><h4>Qualifications</h4><ul><li>Doctoral degree in chemistry, pharmacology, toxicology, or similar field with commensurate experience</li><li>15+ years of experience</li><li>Demonstrated ability to work effectively within or lead a team of peers, as well as excellent interpersonal and communications skills</li><li>Ability to communicate complex analyses at a level comprehensible to laymen and senior-level government representatives</li><li>Demonstrated knowledge of adversary chemical programs, trends, and technologies, strategic weapons developments, WMD, and/or counterproliferation</li><li>A working familiarity with global chemical infrastructure, technologies, and initiatives</li><li>Understanding of global technology control, arms-control, and nonproliferation efforts associated with chemical and strategic weapons (OPCW, CWC, Australia Group)</li><li>Deliverables would include work products related to the development and management of programs within current and planned BARDA chemical threat medical countermeasures advanced development and acquisition contracts</li><li><strong>Ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></li></ul><h4><br>LMI is an Equal Opportunity Employer. LMI is committed to the fair treatment of all and to our policy of providing applicants and employees with equal employment opportunities. LMI recruits, hires, trains, and promotes people without regard to   race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, disability, age, protected veteran status, citizenship status, genetic information, or any other characteristic protected by applicable federal, state, or local law. If you are a person with a disability needing assistance with the application process, please contact <a href="mailto:accommodations@lmi.org" target="_blank">accommodations@lmi.org</a><br>Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.<br><br><b>Need help finding the right job?</b><br></h4>We can recommend jobs specifically for you!Click here to get started.<br>

Senior Chemical SME

<br><h4>Overview</h4><p>LMI is seeking a <strong>Senior Clinical Studies Physician&nbsp;SME&nbsp;</strong>to support the Biomedical Advanced Research and Development Authority (BARDA). <strong>This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></p><p>The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, software, Assay chemistry, microbiology, virology, immunology.</p><p>LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.</p><p>LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!</p><h4>Responsibilities</h4><ul><li>Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.</li><li>Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.</li><li>Participate as subject matter experts on Program Coordination Teams (PCTs).</li><li>Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed.</li><li>Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.</li><li>Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.</li><li>Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.</li><li>Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.</li><li>Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.</li><li>Provide recommendations for project development level portfolio management and oversight as required.</li><li>Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.</li></ul><h4>Qualifications</h4><ul><li>Minimum of fifteen (15) years of relevant industry experience beyond doctoral degree</li><li>Application of advanced degree(s) in medicine or pharmacy or related field with experience in development of medical countermeasures, including vaccines and therapeutics</li><li>Current, active, full, and unrestricted license or registration as a Physician from a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States</li><li><strong>Ability to obtain a public trust clearance. You must be a U.S. citizen.</strong></li></ul><h4><br>LMI is an Equal Opportunity Employer. LMI is committed to the fair treatment of all and to our policy of providing applicants and employees with equal employment opportunities. LMI recruits, hires, trains, and promotes people without regard to   race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, disability, age, protected veteran status, citizenship status, genetic information, or any other characteristic protected by applicable federal, state, or local law. If you are a person with a disability needing assistance with the application process, please contact <a href="mailto:accommodations@lmi.org" target="_blank">accommodations@lmi.org</a><br>Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.<br><br><b>Need help finding the right job?</b><br></h4>We can recommend jobs specifically for you!Click here to get started.<br>

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