Biomedical Specialist - Biomanufacturing

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The Cedars-Sinai Biomanufacturing Center (CBC) is a state-of-the art facility that comprises of a cGMP cell manufacturing facility housing multiple cleanroom cell production suites and process development rooms for producing the next generation of cell and gene therapies. With world class expertise in stem cell (iPSC) biology, bioprocessing, translational, regulatory and manufacturing, Cedars-Sinai is committed to pushing the frontiers of medicine and discovering new technologies and innovations that will impact how we diagnose and treat disease. To learn more about the CBC, please visit: Biomanufacturing Services | Cedars-Sinai (cedars-sinai.org)

The Biomedical Specialist participates in project development for multiple projects while performing process development, validation, and qualification tasks associated with the project. This role proactively completes assigned projects, and uses advanced knowledge and experience to independently conduct, analyze and report studies. As a Biomedical Specialist, providing communication, guidance, and advice that contributes to the success of projects is expected, as well as training of entry level staff project related activities. Additionally, the Biomedical Specialist performs routine and increasingly complex laboratory tasks and procedures and develops technical expertise in one or more areas relevant to research projects. This position may be responsible for writing or aiding in the writing of SOPs for the project.

Primary Duties and Responsibilities

• Performs tasks related to the project.
• Performs project related techniques in accordance to established standard operating procedures (SOP) with accurate documentation and assists cross functional teams with required activities.
• Participates in research activities involving all aspects of the research or protocol process, including investigation, technical, testing/validation of results, and report findings.
• Writes and maintains good documentation practices, and ensures all documentation compliances with all Federal and State accrediting agency requirements, including the Food and Drug Administration (FDA) requirements as necessary.
• Writes or aids in the writing of SOPs and maintains computer database. Performs second reviewer duties for SOPs.
• Maintains lab equipment and related records and responsible for ordering and vendor management.
• Verifies samples received, logs samples into systems, and transports to appropriate environment within the facility for storage following SOPs.
• Writes or assists in the writing of reports and manuscripts and is expected to communicate findings in oral presentations.
• Maintain material inventories and ensures all equipment and materials are ready for project tasks.
• Assists and trains staff on day-to-day lab operations and procedures.
• Ensures all activities comply with regulatory guideline and safety standards.
• Performs lab maintenance duties, including glassware cleaning and sterilization.

Department Specific Responsibilities:

• Experience with genus and species identification of various microbes, applying GMP in QC Lab, implementing CAPA and initiating change control is desirable.
• Experience with maintenance of analytical and retain sample inventory logs under GMP compliance.
• Experience with microbiology techniques, aseptic techniques, sterile gowning and cleanroom operations.
• Proficiency using primary cell culture, cultured cell lines, and sterile technique.
• Proficiency executing microbiology tests including: sterility, micoplasma, Gramstaining, microbial identification and endotoxin determination.