Manufacturing Biomedical Technician - GMP Biomanufacturing Center
Cedars-Sinai Medical Center
Location: Los Angeles, California
Internal Number: HRC0938709B
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. These new therapies will be used for human IND-enabling clinical trials. 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 change how we diagnose and treat disease.
Are you ready to be a part of breakthrough research?
The QC Biomedical Technician participates in projects to develop and achieve goals related to various projects and performs tasks associated with the project in accordance to established standard operating procedures (SOP). Responsible for maintaining lab equipment and performing lab maintenance duties including cleaning, sterilization and keep maintenance records. Performs activities strictly according to SOPs, with accurate documentation, and assists cross functional teams with required testing activates as needed. Contributes to the success of projects by keeping accurate and detailed records of experiments and results and will be expected to help supervisor generate reports.
Primary Duties and Responsibilities:
Performs tasks for multiple projects in accordance to standard operating procedures.
Assists with tasks as required.
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.
Maintains material inventories, and places orders for equipment and supplies
Assists in the operation of specialized equipment and machinery.
Performs a variety of Quality Control functions in support of cGMP aseptic Biological manufacturing and process development. Quality Control 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, 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.
May be asked to perform statistical analysis to generate trend reports on environmental monitoring and product release data. Handwriting must be legible.
Bachelor of Science degree in molecular biology, biochemistry or related science/engineering field is required.
Experience and Skills:
One (1) year of experience working in a lab environment or industrial scientific setting.
Knowledgeable in molecular biology techniques including mRNA, DNA extraction, RT-PCR, PCR, expression analysis.
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.
Maintains compliance with established laboratory SOPs, GMP, MTA's and safety procedures.
Well-organized and detail-oriented with meticulous record keeping and a desire to ensure accurate results.
Working Title: Manufacturing Biomedical Technician - GMP Biomanufacturing Center Department: CS Biomanufacturing Facility Business Entity: Academic / Research Job Category: Biomanufacturing Job Specialty: Biomanufacturing Position Type: Full-time Shift Length: 8 hour shift Shift Type: Day
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 opport...unities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching 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.