Cedars-Sinai Manufacturing Biomedical Technician - GMP Biomanufacturing Center in Los Angeles, California
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.
To learn more about the CBC, please visit Home - CSBIO (csbiomfg.com).
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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
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.