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Research Scientist

Company: Baylor Scott & White Health
Location: Dallas
Posted on: April 10, 2021

Job Description:

The cGMP Manufacturing Research Scientist reports to the cGMP Core Manager and independently performs specialized techniques in an FDA-regulated core lab to develop, manufacture, test human cellular based products for quality and ship investigational cellular products for therapeutic use in human phase I/II clinical trials. The manufacturing activity in the GMP varies based on sponsor requirements but are generally , autologous or donor-derived cell products such from NK cells, T cells and Dendritic Cells. The cGMP Lab Specialist ensures all activities in the lab complies with Federal, State and local regulations and policies. WHAT IS EXPECTED (ESSENTIAL FUNCTIONS) Performs experiments to define the cellular product(s), manufactures and QC tests and releases qualification batches and batches for human phase I/II clinical trials. Creates study specific SOPs, lab forms and clinical forms. Compiles Chemistry, Manufacturing and Control (CMC) information for the IND submission and responds to FDA Review questions. Coordinates with other BSWRI core facilities for study sample collection, processing, storage and analysis Works closely with PIs and GMP Manager to plan and execute analytical methodologies to support sponsor/investigator project. Trains users and assures that equipment is validated, maintained and operated according to SOPs Establishes written procedures and develops plans for monitoring clinical investigations Develops appropriate monitoring activities based on the complexity of the protocol, number of subjects, rate of enrollment, SOP and staff experience. Conducts sponsor scheduled site visits. Maintains records of findings, conclusions and action taken to correct deficiencies for each visit. Verifies that investigator and/or designee and all involved research staff follow the approved protocol and all applicable federal and local guidelines and GCP guidelines
QUALIFICATIONS

Bachelor's Degree and 12 years of experience or
Master's Degree and 10 years of experience

Must have cell culture and BSL2 experience. Must have Clean room gowning experience.

Keywords: Baylor Scott & White Health, Dallas , Research Scientist, Other , Dallas, Texas

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