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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. 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: Biomanufacturing Services | Cedars-Sinai (cedars-sinai.org)
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.
Bachelor of Science degree in molecular biology, microbiology, biochemistry or related science/engineering field
Experience and Skillset:
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.
Working Title: Biomedical Specialist - Quality Control
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major t...eaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.