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Biomedical Specialist (Cedars-Sinai Medical Center; West Hollywood, CA): Perform current Good Manufacturing Practice (cGMP) regulations and manufacturing production and process development duties for multiple clients, following standard operating procedures (SOPs) for manufacturing processes for each project based on the type of cells, tissues, or organs. Perform process development, validation, and qualifications for cellular production in good manufacturing practice (GMP) and good laboratory practice (GLP) environments for projects and cell lines. Perform tissue culture and aseptic techniques for developing and processing clinical grade and research grade cellular products in accordance to established SOPs. Perform cellular, micro- and molecular biology procedures, including Western blot, Northern blot, DNA and RNA, Polymerase chain reaction (PCR), protein extraction, cell culture, immunohistochemistry, and staining. Write and maintain good documentation practices and ensure documentation complies with Federal and State accrediting agency requirements, including the Food and Drug Administration (FDA) requirements for GMP for cellular products. Write SOPs, review SOPs, and maintain computer database. Maintain lab equipment and related records and be responsible for ordering and vendor management. Verify samples received, log into systems, and transport to appropriate environment within the facility for storage following SOPs. Write cGMP manufacturing production and process development reports and maintain computer database for each line of business. Prepare cGMP production room, maintain material inventories, and ensure all equipment and materials are ready for production. Assist and train staff on day-to-day lab operations, procedures, and cGMP processes and procedures. Ensure all activities comply with regulatory guidelines and safety standards. Participate in research activities or protocols involving all aspects of the process, including investigation, technical, testing and validation of results, and report findings. Perform lab maintenance duties, including glassware cleaning and sterilization.

Salary: $71,240 – $110,427 per year

Send resume to: Sonya Gold, Cedars-Sinai Medical Center, 6500 Wilshire Blvd., Los Angeles, CA, 90048

Minimum requirements: Bachelor's degree or foreign equivalent in bioinformatics, biological sciences, chemistry, or related field, plus three (3) years of experience as a Research Associate or related occupation.

Must have experience with the following: process development, validation, and qualification tasks associated with the cGMP; inwriting and aiding in the writing of SOPs for the project and performing related techniques according to established SOPs; independently conducting analysis and report studies; technical expertise in areas relevant to research projects, ordering and maintaining lab equipment, and vendor management; research activities involving all aspects of the research or protocol process (investigation, technical, testing and validation of results, and report findings); qualifying, validating, and transferring analytical methods for testing biological drug substances and drug products with guidance from management; performing tissue culture and microbiological methods, and utilizing good aseptic techniques and lab practices to develop, process, and manufacture research and clinical grade cellular products under established SOPs; performing cellular, micro- and molecular biology procedures (Western blot, Northern blot, DNA and RNA, and PCR), Flow cytometry, Gene expression analysis, protein extraction, cell culture, immunocytochemistry, and staining); and conducting investigations regarding environmental monitoring (EM) action level excursions and out-of-specification (OOS) results for quality control (QC) tests.