Process Advisor IV
Ke`aki Technologies - Fort Belvoir, VA

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Ke`aki Technologies, LLC, headquartered in Honolulu, Hawaii, is a Native Hawaiian Organization (NHO) owned business. A premier government services company, Ke`aki Technologies offers a full spectrum of solutions that improve the performance and operational effectiveness of our government and Department of Defense customers. Our mission synchronized solutions are designed to deliver exactly what our customers need, when they need it. From base and range operations to biomedical defense support to telecommunications and IT services, we deliver the exact talent, tools and technologies needed to meet mission requirements.

Ke`aki Technologies has an exciting opportunity for a Process Advisor . The position will be located at the Omnibus Program and Engineering Technical Support Center (OPETS) located in Ft. Belvoir, VA. This position requires a security clearance and a signed confidentiality agreement.

Please note: This position is contingent upon award.

DUTIES INCLUDE:
  • Provides scientific and technical support during the development or transfer of new biologics and other medical technologies.
  • Assists in determining strategic direction of the project office by proposing and implementing actionable strategies to address critical issues.
  • Review pertinent correspondence and related documents for scientific and medical content, and evaluate all aspects of the clinical study protocol.
  • Provide insight on current good laboratory and manufacturing processes, as well as the following FDA requirements:
    o Animal rule application and implementation
    o Investigational New Drugs (INDs) and biologic license application (conformance to to new drug regulations and the submission, approval and licensure process)
    o Preparation for and conduct during Type A, B and C meetings
    o Qualification of drug development tools
  • Advises the client on the impact of changing trends in the pharmaceutical industries and FDA policies and requirements, and recommends courses of action.
  • Provides advice on the impact of legislative changes and directives from higher echelons and recommends courses of action.
  • Ensures application of pertinent inter-state and foreign commerce laws and regulations governing manufacturing and shipment.
  • Facilitates communication and coordination with the FDA as required.
QUALIFICATIONS / EXPERIENCE REQUIRED:
  • Successful completion of a full course of study in an accredited college or university leading to a Master’s degree preferably with a major in Engineering, Systems Management, Business Management or a related discipline, and DAU Level III certification in SPRDE, or the civilian equivalent, are required. A combination of a Bachelor’s degree in Engineering, Systems Management, Business Management or a related discipline, DAU Level III certification in SPRDE and 10 years of experience may be substituted for a Master’s degree.
  • 10 years of general experience and 5 years of experience in a program office or similar organization.
  • Experience with start-ups, technology transfers and biopharmaceutical manufacturing is required.
  • Previous experience directing large-scale programs in bioengineering or medical systems development, as well as leading the activities of other acquisition program managers, is desired.
Job Type: Full-Time

FLSA Status: Non-Exempt

Ke`aki Technologies LLC is a fast growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid vacation and sick time; and 10 paid holidays.

For additional information on Ke`aki Technologies, LLC, please visit www.keakitech.com.

Ke`aki Technologies, LLC is proud to be an Equal Opportunity Employer/Affirmative Action Employer (EEO/AA) and applicants will be considered without regard to race, color, religion, age, sex, disability, national origin, marital status, or genetic information.

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