Research - Laboratory/Non-Laboratory, Staff/Administrative
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The mission of The Institute of Translational Health Sciences (ITHS) is to accelerate the translation of scientific discoveries to the clinic and beyond to improve the health of people in our region today. We develop critical resources to help innovators move their discoveries forward. ITHS fosters innovative health research, sustains research resources, and provides education and career development programs. The duties and the responsibilities of this position will directly affect the operational stability of the Institute of Translational Health Sciences and its collaborative relationships with affiliated organizations.
ITHS is looking for a Research Scientist 2 to support the production of modified cellular products for patients participating in clinical protocols of the Clinical Research Center in an ISO-7 clean room facility. The Research Scientist 2 will perform a variety of cutting edge biotechnological procedures in support of clinical trials that require genetic manipulation and/ or manipulation of patient tissues under cGMP guidelines. The candidate will work in a clean room environment requiring special gowning procedures and following Standard Operating Procedures.
Support Execution of Clinical Trials (50%): •Perform aseptic procedures within clean room facility in strict accordance. The position will involve performing extensive cell culture techniques. Verify that procedures completed within the GMP facility is performed within FDA guidelines. •Assist affiliated investigators in developing novel and innovative biological processes for gene and cell therapy clinical trials. •Maintain cell lines, and archive and cryopreserve clinical products for use by clinical investigators. •Facilitate development of investigator-specific SOPs. •Participate with the investigator in translating research quality lab techniques to GMP clean room procedures. •Identify potential conflicts that may arise throughout planning and execution of protocols; collaborate in reaching their resolution. •Compile and analyze data; prepare summaries, charts, and graphs. •Able to work flexible hours, including weekends, to support clinical trials and maintain protocols.
Support Good Manufacturing Process (GMP) Operations (50%): •Draft, implement, and monitor Gene and Cell Therapy Lab SOP's for functions within the GMP facility. •Participate in process validation and perform environmental monitoring program in accordance with FDA guidelines. Conduct quality control procedures. •Participate in facility equipment cleaning procedures following clean room SOP. •Serve as a liaison between vendors, contractors, suppliers, maintenance, and repair personnel and the facility. •Oversee non-university personnel working in the facility. •Maintain cGMP documentation/notebooks for FDA audits in compliance with FDA guidelines. •Participate in the training of UW-affiliated investigators’ technicians in cGMP requirements, SOPs, and use of facility. •Research Sponsors/Stakeholders (e.g. NIH, NSF, other schools or research institutions, etc.) ITHS is a NIH funded institute.
MINIMUM REQUIREMENTS •Bachelor's Degree in Biological Science or similar Degree. •One to three years of job-related experience. •Basic understanding of FDA cGMP regulations and guidelines.
Equivalent education and/or experience may substitute for minimum requirements.
CONDITIONS OF EMPLOYMENT •Employee must undergo blood borne pathogen and HIPPA Compliance training. •Employee must be willing to work a flexible schedule in a highly regulated environment.
Application Process: The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment, you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.
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