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Medical Diagnostics Subject Matter Expert

at Tunnell Consulting

Posted: 10/1/2019
Job Reference #: 9222
Keywords: medical

Job Description

Overview:

The successful candidate will be a Diagnostics subject matter expert, with significant in-vitro diagnostics (IVD) product development industry experience.  He/she will provide scientific, technical, and product development advice to the Biomedical Advanced Research and Development Authority (BARDA).   The scope entails supporting the advanced research, full development, regulatory filings and clearances, and commercial manufacturing and performance of laboratory-based and point-of-care diagnostic tests produced by test developers under contract to the U.S. government.   Some emphasis on clinical diagnostics may also be required.  The Diagnostics SME is expected to clearly communicate thoughts and ideas to senior government managers and serve as a reliable resource of technical and product development counsel, at the direction of the government.  The candidate will provide an interface between the government operational staff (project officers and contract officers) and BARDA contractors (product developers).  The candidate must exhibit an extraordinary degree of ingenuity, creativity and resourcefulness in the application and development of advanced biotechnologies, technical and scientific principles, theories, and concepts.  This SME will apply those skill sets to aid the government in developing and acquiring effective laboratory-based, point-of-care, and in-home diagnostics that predict patient infection from Category A and B pathogens/agents.  BARDA is a matrix organization that requires each member to contribute in his/her area of expertise.  The candidate will be responsible for scientific/technical problem solving, data analyses, documentation of procedures and results, and writing progress and final reports. 

Duties & Responsibilities:

  • Serve as a scientific and technical representative to the DHHS Contracting Officer (CO) and Program Officer (PO) (or COTR, as applicable) concerning laboratory-based, quick response, point-of-care, and in-home IVD’s spanning:
    • advanced development,

    • development, verification, and validation,

    • regulatory filings and processes leading to FDA clearance,

    • reliable, robust, and scalable commercial manufacturing.

  • Review and give expert analysis regarding documents generated by BARDA Advanced Research and Development (AR&D) and Project Bioshield (PBS) contractors and federal employees for scientific / technical correctness and regulatory compliance.
  • Render technical / regulatory compliance opinions to the PO / CO / COTR.
  • Actively participate in meetings with federal and contractor employees to obtain and evaluate project status and progress against contract milestones. 
  • Where/when required, perform site visits with PO/CO (COTR or other designated representative) to contractor facilities, and/or facilities of subcontractors, to verify compliance with contract requirements, federal regulations and guidelines.
  • Prepare a risk management program for the developmental, regulatory submissions, and commercialization processes to assess and monitor the various tasks associated with the project.
  • Inform PO/CO/COTR of any increase/decrease in risk to success of the project and generate contingency risk reduction plans.   
  • Provide concept ideas for Project BioShield preparedness and response acquisitions.
  • Prepare draft statements of work (SOW)/statements of objectives (SOO) for Requests for Proposals (RFP). 
  • Assist in contract negotiations on scientific / technical matters as requested.
  • Use extensive technical and industry knowledge to provide insight and technical counsel concerning BARDA’s strategic position within the medical device / diagnostics developmental and manufacturing communities.
  • Independently perform activities consistent with established organizational practices, precedents, policies and strategic objectives set forth by BARDA management.

Requirements:

  • A PhD or equivalent in biochemical, microbiological, immunological, biomedical, or closely related scientific disciplines is required.   An MS could qualify, if backed by 20 or more years of industry experience.
  • 15 or more years of experience in one or more of the following areas:
    • IVD product development, with specific experience and accomplishments in point-of-care, rapid-diagnostics testing.
    • FDA diagnostic and medical device clearances, approvals, and licensures.
    • Diagnostic assay development for Category A and B agents / pathogens (preferred, but not required). 
    • Advanced accomplishments in IVDs for other CBRN threats (natural or man-made) (if Category A or B assay development experience is lacking).
  • The successful candidate may have government and/or academic accomplishments, but those are secondary to actual IVD industry experience.
  • Substantial IVD advanced development skills should be demonstrable. 
  • Substantial skills in IVD process manufacturing should be demonstrable.
  • Substantial Influenza product development expertise should be demonstrable.
  • Working familiarity with FDA current Good Manufacturing Practices (cGMP) is a plus.
  • Working experience with Design Control, Quality Systems Management, and ISO 13485 principles is essential.

Project Management:

  • 7 or more years’ experience meeting multiple milestones on fast-paced projects

  • Project Management Professional (PMP) certification would be a plus

  • Oversight of IVD products through all developmental phases

  • Ability to manage multiple device/diagnostics subcontractors

  • Good track record of on-time delivery for project milestones