Position Description

Clinical Laboratory and Assay Support Director
Location MD - Fort Detrick - NIAID-IRF
Job Code 7052
# of openings 1
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Laulima Government Solutions, LLC is looking for a qualified Clinical Laboratory and Assay Support Director to support our contract with NIAID.

 

JOB DESCRIPTION:

  • Manages IRF-Frederick clinical laboratory specializing in clinical and nonclinical sample testing including but not limited to blood chemistry, hematology, coagulation analysis, and periodic clinical samples analyses to include virus neutralization and immunogenicity testing of patient blood samples.
  • Performs and manages teams to conduct manual and automated procedures on patient and animal samples such as serum, blood, urine, semen, tissue, aspirates, swabs, body fluids, and stool.
  • Performs assay optimization and robustness characterizations for high-throughput analysis of a wide variety of in vitro studies involving high-consequence pathogens.
  • Identifies and enrolls the laboratory in an approved proficiency testing (PT) program to meet the necessary data reporting standards for clinical and nonclinical projects.
  • Manages a group of testing personnel following established standard operating procedures for specimen handling and processing, test analysis, reporting of results to team leads, supervisors, and leadership.
  • Establishes or verifies test performance specifications. Monitors quality control testing.
  • Oversees occasional assay validation and/or performance qualification, as needed, prior to implementation.
  • Provides technical and supervisory direction to ensure that laboratory testing comply with individual project needs established by IRF leadership and collaborative partners.
  • Trains bench personnel when new procedures or systems are implemented.
  • Advises contract and Government leadership on ideas and methods to enhance efficiencies or capabilities.
  • Builds, maintains, and works within a team on collaborator-driven projects; cultivates a constructive and highly productive synergistic teams-within-teams environment.
  • Oversees study planning with Study Directors and Collaborators to ensure appropriate measurements and sampling schedules are included in study plans.
  • Reviews literature regularly to maintain knowledge of evolving methods, techniques, technological advances, and regulatory changes.
  • Actively participates in practices/processes to continuously enhance data quality, integrity, and assurance including periodic development and/or review of study execution methods, and Standard Operating Procedures (SOPs) to identify and close gaps and refine procedures in line with regulatory and top-tier journal expectations.
  • Complies with the NIH Division of Occupational Health and Safety requirement for satisfactory completion of the Biosurety program and Select Agent program.
  • Publishes results in peer-reviewed, ideally high impact, national and international journals.
  • Complies with the physical security, protection of the division’s property, protection of information, cyber security, agent protection, control and accountability, safe disposal and waste handling, and personal security guidelines set forth by the division’s Biosurety program.

REQUIRED SKILLS AND EXPERIENCE:

  • Experience as a CLIA Laboratory Director.
  • Proficiency in development and troubleshooting of clinical pathology instrumentation and bioassays including but not limited to ELISA, PCR, and neutralization assays.
  • Proficiency with laboratory information management systems (LIMS).
  • Direct experience in data integrity assessments and assay qualification/validation.
  • Demonstrated track record of leading scientists and technical support staff.
  • Must be a US citizen or permanent resident.
  • Must be able to obtain/maintain DoJ Security Risk Assessment (SRA) approval.
  • Must be willing to be immunized with licensed and FDA-approved Investigational New Drugs (IND) recommended for persons at risk to occupational exposure of biological agents.
  • Must be willing to participate in periodic drug screening.
  • Must have the ability to obtain/maintain certification in Chemical Personnel Reliability Program and/or Biological Personnel Reliability Program.
  • Must have the ability to obtain/maintain CDC Select Agent Program approval.
  • Must be willing to work under BSL-2, BSL-3, and in particular BSL-4 conditions. Able to wear respiratory protection. • Ability to work independently, design experiments, and analyze, summarize, and present data.

DESIRED SKILLS:

  • At least 2 years current experience working in a BSL-3 or BSL-4 laboratory, with BSL-4 experience preferred.
  • Experience with viral Select Agents is desired, but not required.
  • Interpersonal, oral and written communication, and organizational skills.

DEGREE/EDUCATION/CERTIFICATION REQUIREMENT:

  •  Minimum of a Ph.D. or equivalent degree in a chemical, physical, biological or clinical laboratory science from an accredited institution
  • 5 years of full-time clinical laboratory experience in Chemistry, Hematology, Microbiology, Immunology and Urinalysis/Body Fluids.
  • Certification from the American Society for Clinical Pathology (ASCP), American Medical Technologist (AMT) or other board or registry deemed comparable by Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) or their designee as a Medical Technologist (MT) or Medical Lab Scientist (MLS) is required. (Copy of certification must be submitted with application package.)
  • Strong background in assay development and optimization.

CITIZENSHIP/SECURITY CLEARANCE REQUIREMENTS:

  • Must be a US Citizen or Permanent Resident

Laulima Government Solutions, 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 time off; and 10 paid holidays. Laulima Government Solutions, LLC is proud to be an equal opportunity employer.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. If you are a person with a disability and you need an accommodation during the application process, please click           here         to request accommodation. We E-Verify all employees.

The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, Kūpono Government Services, and Kapili Services, Po`okela Solutions,  Kīkaha Solutions, LLC,  and Pololei Solutions, LLC.  Alaka`ina Foundation activities under the 501(c)3 principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.

For additional information, please visit  www.alakainafoundation.com

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