Research Scientist
Company: Baylor Scott & White Health
Location: Dallas
Posted on: January 15, 2021
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Job Description:
The cGMPManufacturing Research Scientist reports to the cGMP
Core Manager andindependently performs specialized techniques in an
FDA-regulated core lab to develop,manufacture, test human cellular
based products for quality and shipinvestigational cellular
products for therapeutic use in human phaseI/II clinical trials.
The manufacturingactivity in the GMP varies based on sponsor
requirements but are generally, autologous or donor-derived
cellproducts such from NK cells, T cells and Dendritic Cells. The
cGMP Lab Specialist ensures all activitiesin the lab complies with
Federal, State and local regulations and policies. WHAT ISEXPECTED
(ESSENTIAL FUNCTIONS) Performsexperiments to define the cellular
product(s), manufactures and QC tests and releasesqualification
batches and batches for human phase I/II clinical trials.
Createsstudy specific SOPs, lab forms and clinical forms.
CompilesChemistry, Manufacturing and Control (CMC) information for
the IND submissionand responds to FDA Review questions.
Coordinateswith other BSWRI core facilities for study sample
collection, processing,storage and analysis Worksclosely with PIs
and GMP Manager to plan and execute analytical methodologiesto
support sponsor/investigator project. Trainsusers and assures that
equipment is validated, maintained and operatedaccording to SOPs
Establisheswritten procedures and develops plans for monitoring
clinical investigations Developsappropriate monitoring activities
based on the complexity of the protocol,number of subjects, rate of
enrollment, SOP and staff experience. Conducts sponsorscheduled
site visits. Maintains records of findings, conclusions and
actiontaken to correct deficiencies for each visit. Verifiesthat
investigator and/or designee and all involved research staff follow
theapproved protocol and all applicable federal and local
guidelines and GCPguidelines *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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