LMI

Non-Clinical Advisor

Job Locations US-MD-Fort Detrick
Posted Date 2 months ago(5/29/2024 4:49 PM)
Job ID
2024-11417
# of Openings
1
Category
Other

Overview

LMI is seeking a qualified Bioengineer to support our Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear (JPEO-CBRND) Joint Project Manager for Medical Countermeasure Systems (JPM MCS) client at our Ft. Detrick, MD location. This position allows for partial telework. Active Secret clearance preferred; only candidates eligible for a Secret level clearance will be considered (US Citizenship required).

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.

 

We believe government can make a difference, and we seek talented, hardworking people who share that conviction. We offer a generous compensation package with excellent benefits that start the first day of employment. Business casual dress, flex time, and tuition reimbursement are a few of our many work-life benefits available to our employees.

Responsibilities

  • Serve as the technical interface between non-clinical stakeholders and contractors in order to establish studies designs and achieve regulatory quality standards.
  • Perform a leadership role, problem-solving technical issues related to nonclinical studies and communicating solutions and emerging risks, accurately and timely, to the Vaccine Manager, Deputy JPM, and other staff members.
  • Work with IPTs comprised of civilians, military and non-Government personnel, and matrix support staff with diverse areas of expertise (i.e., PMs, budget analysts, regulatory specialists, acquisition analysts, and logisticians).
  • Work with diverse product development teams, to include Government personnel and other performers (e.g., statisticians, veterinary anatomic pathologists, veterinary clinical pathologists, toxicologists, clinicians, pharmacologists, formulation scientists, etc.).
  • Represent the organization, communicating with individuals both in and outside the organization, to include customers, the public, and other Government agencies and external sources.
  • Derive interpretations from data and design subsequent experiments with minimal oversight in support of non-clinical testing of vaccines under the Animal Rule.
  • Review all aspects of testing and data analysis in order to generate detailed and well-documented recommendations to be provided as guidance for a path forward.
  • Contribute critical scientific and regulatory elements for high-quality nonclinical study protocols, to include:
    • Reviewing proposals for advising PMs and external performers of expectations in the forthcoming study protocol content
    • Ensuring that relevant, Industry-standard scientific practices are included to prevent both a)
      critical data gaps at the time of interpretation and b) excess, unnecessary efforts that do not serve the furtherance of study objective(s)
    • Ensuring that the study protocol uses correct scientific and regulatory designations, terminology, and section formatting to serve as the framework to the report
  • Conduct draft report reviews of non-clinical studies based on exhaustive data review to ensure:
    • Technical and scientific data integrity
    • Correct or defensible written interpretation of data (as indicated)
    • Reporting limited to the scope of data within the study
    • Appropriate written explanatory is provided for each data set
    • Adherence to compliance with appropriate regulatory standards
  • Provide consultation to clients in the design of experimental studies and protocols, interpretation of experimental results, review of study reports, and recommendations from other performer(s).
  • Interpret the meaning of information for others, to include:
    • Translating or explaining what the information means and how it can be used
    • Generating, interpreting, and communicating results from in vivo nonclinical studies to teams including other advanced development scientists, PMs, and non-scientists)
  • Review other performers’ implementation of activities to ensure they are in compliance with Good Laboratory Practice, standard operating procedures, protocols, and regulations related to ethics and animal welfare.
    • Ensure that experimental data are being properly collected
    • Participate in performer site visits and/or on-site audits as needed
  • Maintain current technical knowledge and skills, applying them to the job as necessary.
  • Maintain communication with supervisors, peers, or subordinates via telephone, e-mail, or in person.
  • Work independently and as part of a team.
  • Ensure appropriate subject matter experts are involved in the day-to-day management of non-clinical studies (e.g., biostatistician, toxicologist, biologists, clinicians, pharmacologists, etc.).
  • Participate in source selection panels as a subject matter expert in reviewing relevant sections of submitted proposals of vaccine development.

Qualifications

  • Required: PhD in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as Fifteen (15) years of general experience and ten (10) years of relevant experience OR possess a Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as Twenty (20) years of general experience and ten (15) years of relevant experience.
  • Strong technical training in non-clinical studies to support medical countermeasures in preclinical studies for an IND.
  • Five (5) years of experience designing and conducting medical countermeasures in non-clinical studies for an IND.
  • Ability to independently design, critically evaluate, and execute non-clinical studies.
  • A familiarity and understanding of regulatory guidelines (i.e., FDA GLP and/or GMP) and regulatory/quality compliance requirements. Experience in a regulated laboratory environment is preferred.
  • Strong interpersonal and communication skills, both oral and written.
  • Strong critical thinking, analytical, and problem solving skills, as well as good organization skills to balance and prioritize work.
  • Active Secret clearance preferred; only candidates eligible for a Secret level clearance will be considered (US Citizenship required).

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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 accommodations@lmi.org

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