Bioengineer III

Company Info
The Tauri Group
VA, United States

Phone:
Web Site: http://taurigroup.com/

Company Profile
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Title:

Bioengineer III

Location:

Frederick, MD 

Salary:

up to 115K

Job ID:

35152
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Job Description:

We are seeking a lead scientist who understands the drug development/FDA processes to support the JPEO-CBD JPM Medical Countermeasures Systems, Chemical Defense Pharmaceuticals (CDP) at Ft Detrick MD.  The ideal candidate is someone who has demonstrated experience working on programs that moved products through the drug development process.
Candidates must have a current SECRET clearance  
Education and Experience Required
  • Education: Bachelor of Science degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline.  It is highly desired that candidates have a Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline
  • 8 -10 General Experience; 5-7 Relevant Experience
  • Industry experience in pharmaceutical/biotechnology advanced development
  • Proficiency in MS Office Programs
Desired
Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline
Certification in Regulatory Affairs; Project Scheduling
Responsibilities
  • Serves as the technical representative on project teams, supporting risk planning efforts and providing advice and assistance in implementing process improvements for advanced development efforts (i.e., clinical, non-clinical, and manufacturing).
  • Serves on internal and external Integrated Product Teams (IPTs), responsible for organizing meetings, preparing agendas, documenting meeting minutes and action items, etc.
  • Serves as the technical point of contact, participating in contractor site visits, assisting in monitoring performance and quality standards, and providing technical oversight during study execution.
  • Serves as the technical representative at conferences and stakeholder meetings.
  • Provides scientific/technology advice, technical oversight, and project management support in the areas of science and technology availability, technology maturity, and applicability of proposed candidate CBRN medical countermeasures through advanced development, production, and fielding.
  • Provides technical knowledge to guide the product team in establishing a link between clinical and non-clinical efficacy, developing a robust manufacturing strategy, and defining product development schedules.
  • Provides written technical opinions to guide the decision making process of the IPT.
  • Collaborates with project teams and participate in the evaluation of technical results in multiple developmental areas, developing strategies to move the program forward.
  • Collaborates with both internal and external partners, contributing to data analyses in order to create and submit study results to publications or the FDA.
  • Conducts research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
  • Provides periodic update reports to program managers.
  • Assists the program managers in assessing schedule risks and developing mitigation strategies.
  • Provides technical input to acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations.
  • Develops drafts and/or review and provide edits/comments to technical documentation (i.e., development/technology transfer reports, batch records, standard operating procedures, and regulatory submissions).
  • Authors, edits, and contributes in the development of robust product development plans to support FDA approval under the Animal Rule.
  • Prepares and/or reviews draft protocols and study plans pertaining to a range of developmental efforts (i.e., manufacturing, non-clinical, clinical, and assay development), providing feedback in support of advanced development efforts. These activities will include collaboration with both internal and external partners
  • Develops drafts and assist the project team to coordinate responsibilities, oversee quality management, and encourage timeliness of completion of protocols, IND applications, other regulatory submissions, and technical reports.
  • Prepares 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.
  • Maintains current knowledge on new technologies and methodologies that may benefit the program, assessing technical proposals critically and effectively, providing written technical opinion on the feasibility of new technologies, and organizing brown bag seminars to allow the Joint Product Offices to review the technologies.
  • Reviews and searches scientific literature and databases in order to identify technical information and to provide references to support product development efforts.