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 in external collaborations and prepare reports
- Other duties as assigned
ROLE FLEXIBILITY:
It is understood that the incumbent will be expected to display flexibility and, when pertinent, one should be able to work in other priority areas within the foundation. Such transient changes in duties will not represent a change in status and will not place an onerous burden on the incumbent.
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.
PHYSICAL DEMANDS:
None
HAZARDOUS WORKING CONDITIONS:
One would not be exposed to hazardous conditions unless working in the lab.
All lab work is BSL-2. Hazards may include, but are not be limited to, BCG, rBCG, Shigella, adenovirus, human and NHP blood, samples that may contain low levels of TB, and clinical samples. BSL-3 lab work involving virulent M. tuberculosis is performed at partner institutions and incumbent may be required occasionally to provide training in these facilities.
Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.
Job Details |
Job Location |
Candidate Application |
| Employer: Aerotek Scientific | Address: 6810 Deerpath Road | Contact: Lindsay B Mullenix |
| Job Type: Full-time | City: Rockville | |
| Experience:Any | State: Maryland | E-mail: lmulleni@aerotek.com |
| Education: Any | Zip Code:20852 | Online: Website Link |
Rate: Based on experience.
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