Biomedical Scientist (Cedars-Sinai Medical Center; West Hollywood, CA): Supervise and perform manufacturing production and process development projects based on current good manufacturing practices (cGMP) for multiple clients, following standard operating procedures (SOPs) for manufacturing processes that will be different for each project based on the type of cells, tissues, or organs. Perform process development, validation, and qualifications for cellular production in a good manufacturing practice (GMP) and good laboratory practice (GLP) environment. Perform and maintain good documentation practices, and ensure all documentation complies with Federal and State accrediting agency requirements, including Food and Drug Administration (FDA) requirements in GMPs for cellular products. Finalize cGMP manufacturing production and process development reports and maintain computer database. Provide guidance, technical expertise, and evaluation of client processes. Make recommendations for improvement of client processes. Plan and assign projects, monitor work, identify issues and problems, and make plans to resolve problems. Supervise a production team, tissue culture techniques, aseptic techniques, and the writing of SOPs for developing and processing clinical grade and research grade cellular products. Manage assigned projects and associates’ activities in a regulated working environment. Assist with the cGMP manufacturing schedule. Draft overall timeline for projects as reference for finalizing manufacturing productions. Prepare written and verbal updates and findings, including slide presentations, and present manufacturing production updates. Ensure all activities comply with regulatory guidelines and safety standards by monitoring all ongoing activities and interacting regularly with QA and Regulatory Affairs. Write and record controlled documents for assigned projects. Lead projects, train, and assist other manufacturing associates on day-to-day lab operations and procedures. Monitor performance, complete performance appraisals, and address performance issues. Perform and train associates on all cGMP/GLP related activities. Coordinate and assist quality control team with all required testing activities. Review and remain current on literature as it relates to clinical and research studies. Develop hypotheses and assist in planning steps for the investigative process.

Minimum requirements: Bachelor’s degree or foreign equivalent in Molecular Biology, Biochemistry, Pharmaceutical Science, or a related field, plus eight (8) years of experience as a Biomedical Scientist, Research Scientist, Biomedical Professor, Pharmaceutical Professor, or related occupation.

Must have experience with the following: cGMPs and 21 CFR Part 211; authoring and reviewing Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and Master Production Records (MPRs); Food and Drug Administration (FDA) requirements in good manufacturing practices (GMP); CAPA and Deviation and Risk Assessment procedures; working in a GMP/GLP regulated facility; working in an aseptic environment; and working in a biosafety cabinet.

Salary: $138,570 per year

Send resume to: Sonya Gold, 6500 Wilshire Blvd., 6th Floor, Los Angeles, CA 90048