With your help, we can change the future of healthcare!

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. With our world-class expertise in stem cell (iPSC) biology, bioprocessing, translational medicine and manufacturing, the CBC is providing a much-needed biomanufacturing center in Southern California! To learn more about the CBC, please visit Home - CSBIO (csbiomfg.com).

The Biomedical Specialist participates in project development for multiple projects. Performs process development, validation, qualification tasks associated with the project. May be responsible for writing or aiding in the writing of SOPs for 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. Proactively completes assigned projects, and uses advanced knowledge and experience to independently conduct, analyze and report studies. Will be expected to provide communication, guidance, and advice that contributes to the success of projects. Trains entry level staff project related activities. Performs routine and increasingly complex laboratory tasks and procedures and develops technical expertise in one or more areas relevant to research projects. Responsibilities include ordering and maintenance of lab equipment, and vendor management. Participates in research activities involving all aspects of the research or protocol process, including investigation, technical, testing/validation of results, and report findings.

Primary Duties and Responsibilities:

• Performs a variety of QC functions in support of cGMP aseptic Biological Drug manufacturing and process development. QC testing will vary for each project based on the type of cells, tissues or organs.
• Performs a broad range of tissue culture and microbiological methods, utilizing good aseptic techniques and lab practices in support of for developing, processing and manufacturing both research and clinical grade cellular products in accordance to established standard operating procedures (SOP).
• Performs cellular, micro- and molecular biology procedures including, but not limited to Western blot, Northern blot, DNA / RNA, Polymerase chain reaction (PCR), Flow cytometry, Gene expression analysis, protein extraction, cell culture, immunocytochemistry, and staining.
• Expected to execute environmental monitoring (EM), QC analysis, provide technical oversite and complete routine record review of test data and related GMP documents under minimal supervision.
• Will conduct investigations regarding EM action level excursions and out of specification (OOS) results for any QC-tests executed within the CBC or by external laboratories.
• Will develop, revise and review SOPs, and monitor GMP systems currently in place to ensure compliance with documented policies.
• Must also have the ability to perform statistical analysis to generate trend reports on environmental monitoring and product release data. Handwriting must be legible.
• Knowledgeable in molecular biology techniques including mRNA, DNA extraction, RT-PCR, PCR, expression analysis
• Maintains compliance with established laboratory SOPs, GMP, MTA’s and safety procedures
• Must be well-organized, detail-oriented with meticulous record keeping and a desire to ensure accurate results.
• Will train new staff on environmental monitoring, analytical and retain samples inventory management and analytical techniques when needed.

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.
• Experience with genus and species identification of various microbes, applying GMP in QC Lab, implementing CAPA and initiating change control is desirable is highly desired.
• Experience with maintenance of analytical and retain sample inventory logs under GMP compliance is a plus.
• Demonstrated ability to apply cGMP knowledge to write procedures and manage projects.
• Prior experience working in an aseptic environment, biosafety cabinet and working with human and animal tissues.