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
Baylor Scott & White Health (BSWH) is the largest not-for-profit health care system in Texas and one of the largest in the United States. With a commitment to and a track record of innovation, collaboration, integrity and compassion for the patient, BSWH stands to be one of the nation’s exemplary health care organizations. Our mission is to serve all people by providing personalized health and wellness through exemplary care, education and research as a Christian ministry of healing. Joining our team is not just accepting a job, it’s accepting a calling!