T-Cell Assay Supervisor Medical Science & Computing, Inc. is searching for a T-Cell Assay Supervisor to support the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is on-site at NIH in Gaithersburg, MD.

Candidate will be responsible for the supervision and oversight for all T-cell based methodologies used in clinical vaccine trial testing. Such assays currently include Interferon-gamma Enzyme Linked Immunospot Assays (ELISpot) and Flow Cytometry based Intracellular Cytokine Staining Assays (ICS). The T-Cell Assay supervisor will report directly to the Testing Laboratory Manager and will be responsible for the establishment of ELISpot/ICS Assay standard practices and supervision of analysts performing those methods.

Essential Duties:
• In coordination with IT, Testing Laboratory and QA managers will be responsible for the establishment and enforcement of standard testing practices within the area of the ELISpot and ICS Assays ; inclusive of: 
    o Appropriate operation and maintenance of instruments such as the Becton Dickinson LSR II, CTL Immunospot Reader, and Guava Flow Cytometer 
    o Appropriate methods of electronic record storage o Appropriate analyst training and proficiency testing 

• As the subject expert in ELISpot/ICS Assay will provide technical insight with other areas inclusive of:     
    o Analytical investigations 
    o New method transfers from the Methods Development Department o Regulatory audits

• Based upon work projections provided by the Testing laboratory Manager will derive the resource needs for ELISpot/ICS Assay. 
    o Maintain inventory of all reagents, materials and supplies needed for T-cell assays 
    o Ensure reagents are suitable for use in clinical testing, including qualifying new lots of reagents or other materials     
    o Assure no delays in testing due to instrumentation and/or supply shortages

• Responsible for the oversight of the daily work performed by the analysts doing ELISpot/ICS Assay to assure the work meets documented practices. 
    o Review/approval of all documentation and data generated in ELISpot/ICS Assay o Work with the analysts to correct any deficiencies in a timely manor 
    o Participate in the performance of daily testing as needed

• Supervisor will manage the ELISpot/ICS Assay area proactively and will effectively communicate emerging issues to the Test laboratory Manager.

• Supervisor is directly responsible to assure that all internal and external audits of the ELISpot/ICS Assay are passed successfully. 
    o If deficiencies are found the supervisor in responsible for providing an acceptable proposal for resolution to the testing laboratory and QA manager.

• Assure practices consistent with industry standards, US Code of Federal Regulation (US CFR), International Committee for Harmonization (ICH) for Good Laboratory Practices.

• Responsible for meeting all time lines and milestones as established by Testing Laboratory Manager.

• Perform other duties as required.

Qualifications:

• Minimum of 2 year’s experience in GLP testing laboratories 
    o Inclusive of extensive experience within specialty area
• Demonstrated ability to evaluate complex situations, evaluate and implement best practices with minimal oversight
• Working knowledge of US CFR, ICH and industry standards for GLP.
• Demonstrated ability to interact with a diverse team of scientists
• Good oral and written communication skills
• Demonstrated ability to multi-task and prioritize projects efficiently
 
Minimal requirements:

• MS degree or BS/BA with 5+ years of relevant experience

Please forward your resumes, cover letters and salary requirements to Careers@MSCweb.com. Please include the job title in the subject line.