Senior Scientist, Immunology

The Senior Scientist will provide leadership and training to, and direct, the Immunology team as part of Vaccine Assessment. Responsibilities will include review and reporting of data generated by the pre-clinical and clinical immunology teams, development and validation, if necessary, of new immunoassays as needed to assess immune correlates and surrogates.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

·        Direct and oversee immunological experiments following Standard Operating Procedures (SOP) and using Good Laboratory Practice and/or Good Clinical Laboratory Practice under Biosafety Level 2 (BSL-2) and on occasion Biosafety Level 3 (BSL-3) conditions

·        Prepare necessary documents for analysis and data transfer of immunoassays, including but not limited to ICS, lymphocyte proliferation, tetramer staining, cytokines and antibodies in serum/plasma, for  clinical vaccine studies

·        Assure that direct reports perform  routine laboratory maintenance, including reagent inventory, instrument calibration, and facility monitoring that meet QA/QC standards for the department

·        Write and implement new SOPs, review and update current SOPs, or assign these duties to a qualified direct report

·        Prepare and/or review reports for all immune response assays including but not limited to: FACS, proliferation, tetramer, serum/plasma

·        Assist Biostatistics Department in assay qualification and preparation for assay validation

·        Assign assay validation to appropriate personnel, oversees performance of validation procedure, assists personnel in preparation of final validation report

·        Assist in further development of processes for shipping, receiving, recording, storing, and data management of all clinical trial samples in accordance to GCLP practices

·        Ensure the maintenance of complete and clear laboratory notebooks by all reports

·        Generate lab progress reports for Annual Reports from funding agencies and presented to Supervisor, Management, Technical Advisory Groups, Vaccine Selection Advisory Committee, and other internal steering committees

·        Coordinate and support project managers with pre-clinical studies by reviewing immunology section of protocols, assigning direct reports to perform assays, and then evaluate and analyze the data with the project managers

·        Assist Senior Director in preparing yearly budgets based on upcoming studies and reviewing budgets, as needed

·        Represent Aeras in external collaborations and prepare reports

·        Other duties as assigned

 

SUPERVISORY RESPONSIBILITIES:

 

The incumbent will have 3 direct reports.  Each of these direct reports has 2-4 direct reports.  The group is made up of 12 people.

 

QUALIFICATIONS AND REQUIREMENTS:

  Ph.D. with 5 or more years of experience in immunology, some experience in clinical studies is highly desired. Experience supervising or training others highly desired. Experience performing daily activities in a GLP/GCLP environment. Experience in multi-parameter flow cytometry and data analyses, primary human cell culture and PBMC cryo-preservation, and the skills to prepare reports of primary and analyzed data is required. Experience in or understanding of qualification and validation of immune assays as well as selection of proficiency panels for multi-center studies that can be applied in clinical vaccine trials is a plus. Flexibility in work hours and international travel are expected.

 

 

Aeras Global TB Vaccine Foundation is an Equal Opportunity Employer. M/F/D/V.