Bioengineer - Security Clearance Required

2 weeks ago

Frederick, United States LMI Full time

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. Active Secret clearance preferred; only candidates eligible for a Secret level clearance will be considered (US Citizenship required).

LMI offers a generous compensation package with excellent benefits that start the first day of employment. Business casual dress, flexible work schedules, and tuition reimbursement are a few of our many work-life benefits available to our employees.

LMI has been named a 2022 #TopWorkplace in the United States by Top Workplaces 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

Responsibilities

Candidate responsibilities will:

  • Serve as the technical representative on project teams, supporting risk planning efforts and providing advice and assistance in implementing process improvements for products.
  • Serve on internal and external integrated product teams (IPTs), responsible for organizing meetings, preparing agendas, documenting meeting minutes and action items.
  • Participate in contractor site visits, assisting in monitoring performance, regulatory and quality standards, and providing technical oversight during production/manufacturing.
  • Serve as the programmatic representative at conferences and stakeholder meetings.
  • Provide technical knowledge to guide the product team through corrective/preventative actions.
  • Collaborate with project teams and participate in the evaluation of technical results in multiple developmental areas, developing strategies to move the program forward.
  • Collaborate with internal and external partners and research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
  • Provide periodic update reports to Product Managers (PMs).
  • Assist the PMs in assessing cost and schedule risks and developing mitigation strategies.
  • Develop drafts and/or review and provide edits/comments to technical documentation (i.e., development/technology transition agreements, and standard operating procedures).
  • Prepare and/or review draft protocols and study plans pertaining to a range of developmental efforts (assay development), providing feedback in support of advanced development efforts.
  • Prepare documentation/presentations to summarize technical results, to include displaying results in “Layman’s” terms, formulating conclusions, and developing technical strategies in response to the data outcomes.
  • Review and search scientific literature and databases in order to identify technical information and to provide references to support product development efforts.
  • Assist to identify and assess risks of new technologies and ongoing projects.
  • Prepare briefing materials.
  • Provide technical oversight and project management support, acquisition program strategic planning, contract guidance, and advisory services for DBPAO commodities with little to no supervision.
  • Serve as a subject matter expert on all program quality initiatives (e.g., internal and external International Standards Organization (ISO) accreditations, existence and completeness audits, quality assurance, quality control, etc.).
  • Develop product test protocols (i.e., validation studies, stability studies, sampling plans with traceability to statistic models, and Defense Biological Product Assurance Office (DBPAO) assay design packages).
  • Provide technical input to acquisition documents and presentations in support of program reviews, or other program presentations.

Qualifications

Successful candidate will:

  • Required: Bachelor’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as ten (10) years of general experience and seven (7) years of relevant experience.
  • Preferred: Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as eight (8) years of general experience and five (5) years of relevant experience.
  • Possess DAU Level I equivalency in Program Management or senior-level experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process). DAU courses will be at Government cost; however, travel costs (ex: Per Diem, lodging, mileage) will not be at Government cost.
  • Possess five (5) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
  • Possess five (5) years of project management experience in cost, schedule, performance, risk analysis, and advice.
  • Possess experience in pharmaceutical/biotechnology drug development portfolio management (i.e., investment decisions based on the risk management process).
  • Possess strong analytical and problem solving skills, as well as good organization skills to balance and prioritize work.
  • Possess extensive customer support/relations experience.
  • Possess strong interpersonal and communication skills, both oral and written.
  • Maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge across and within organizations united for the development of medical countermeasures.
  • Possess five years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.
  • Possess sufficient experience in the use of Microsoft Project and Microsoft Excel to provide a level of proficiency that allows independent development and management of resource loaded Integrated Master Schedules (IMSs) and financial documents.
  • Active Secret clearance preferred; only candidates eligible for a Secret level clearance will be considered (US Citizenship required).

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