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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 Technician participates on projects to develop and achieve compliance with all Federal and State accrediting agency requirements, including Food and Drug Administration (FDA) requirements for good manufacturing practices (GMP) for cellular products in Cedars-Sinai Biomanufacturing Center (CBC). Performs tissue culture and aseptic techniques for developing and processing clinical grade and research grade cellular products in accordance to established standard operating procedures (SOP). Performs process development, validation, and qualification for cellular production in GMP/good laboratory practice (GLP) environment. Responsible for lab maintenance, handling fresh and frozen cellular specimens and products using aseptic techniques, writing and recording controlled documents, and autoclaving for production. Performs all current good manufacturing practice (cGMP) related activities strictly according to SOPs, with accurate documentation, and assists quality control team with required testing activates. Contributes to the success of projects by providing good documentation, communication skills, and attention to detail. Performs cellular, micro- and molecular biology procedures including Western blot, Northern blot, DNA/RNA, PCR, protein extraction, cell culture, Immunohistochemistry, and staining.
Primary Duties and Responsibilities:
Performs a variety of manufacturing and process development tasks for multiple clients following standard operating procedures that will be different for each project based on the type biomedical work.
Writes and maintains good documentation in laboratory notebooks, data record/transfer, SOPs, and batch records.
Drafts standard operating procedures and maintains computer database.
Verifies samples received, logs samples into systems, and transports to appropriate environment within the facility for storage following SOPs.
Performs lab maintenance duties, including glassware cleaning and sterilization.
Maintains lab equipment and related records.
Prepares cGMP production room, maintains material inventories, and places orders for equipment and supplies
Assists in the operation of specialized equipment and machinery.
Ensures all activities comply with regulatory guidelines and safety standards.
Bachelor of Science degree in molecular biology, microbiology, biochemistry or related science/engineering field, required.
Experience and Skillset:
One (1) year of experience in a lab environment, GMP/GLP regulated facility preferred.
Assists with process development, validation, and qualification for cellular production.
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.
Working Title: Biomedical Technician - Manufacuring
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.