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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 Home - CSBIO (csbiomfg.com)

The Biomedical Specialist participates in project development for multiple projects and performs process development, validation, and qualification tasks associated with projects. This role will proactively complete 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 for project-related activities. Additionally, this role will perform 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).
• 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 standard operating procedures 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.
• Participates in research activities or protocols involving all aspects of the process, including investigation, technical, testing/validation of results, and report findings. 
• Performs lab maintenance duties, including glassware cleaning and sterilization.

Education:

• Bachelor of Science degree in molecular biology, microbiology, biochemistry or related science/engineering field, required.

Experience and Skills:

• Two (2) years of experience in GMP/GLP regulated facility. Experience in an industrial scientific setting, preferred.
• Demonstrated ability to apply cGMP knowledge to write procedures and manage projects.
• Must have experience working in an aseptic environment.
• Must have experience working in a biosafety cabinet and have experience working with human and animal tissues.
• Writes good documentation and standard operating procedures.
• Knowledge of good manufacturing (GMP) practices for cellular products.
• Knowledge of regulatory requirement including Federal, FDA, State and accrediting agency requirements.
• Knowledge of specialized equipment and machinery to produce cellular products.
• Ability to use databases.