Cedars-Sinai Biomanufacturing Center (CBC) is a new 22,000 square feet, state-of-the-art biomanufacturing facility located in West Hollywood, California. The CBC comprises 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 combined expertise in a cGMP-compliant approach to manufacture cells at scale, the CBC will overcome many challenges by building innovative technologies, connecting protocols, up-scaling of processes and achieving Food and Drug Administration standards for all steps involved to bring innovative cell therapy solutions to researchers and translation scientists. 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, please visit: Biomanufacturing Center | Cedars-Sinai (cedars-sinai.edu)
The Biomedical Scientist will independently design, conduct, analyze and report studies that have been outlined by your supervisor or the Executive Director. This role will actively propose new avenues of investigation to Supervisor or Executive Director through investigation of the latest literature and new technologies. You will proactively assign projects, leads, and performs tasks and writes standard operating procedures (SOP)s, and are responsible for running assigned projects and managing associates activities in a regulated working environment, writing and recording controlled documents for projects and coordinate and assists QC team with all testing activities where required. In addition, you will supervise lab activities and will be responsible for providing training to other individuals who may be assigned to the project, study, or laboratory, as well as review and remain current on literature as it relates to clinical/research study.
Primary Duties & Responsibilities:
Performs tasks related to the project and plans tasks, assigns work, monitors work, and identifies issues/problems, and makes plans to resolve problems.
Performs and maintains good documentation practices, and ensures all documentation complies with Federal and State accrediting agency requirements, including Food and Drug Administration (FDA) requirements as necessary.
Leads projects, trains and assists other associates on day-to-day lab operations and procedures. Monitors performance, completes performance appraisals, and addresses performance issues. Performs and trains associates project related activities.
Performs a variety of Quality Control functions in support of cGMP aseptic Biological Drug manufacturing and process development. Quality Control testing will vary for each project based on the type of cells, tissues or organs.
Ensures all activities comply with regulatory guidelines and safety standards by monitoring all ongoing activities and interacts with other teams within the organization regularly.
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.
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.
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 EM and product release data. Handwriting must be legible.
Maintains compliance with established laboratory SOPs, GMP, MTA's and safety procedures.
May perform the duties of the Biomedical Technician and must have a thorough understanding of laboratory and research functions.
Train new staff on environmental monitoring, analytical and retain samples inventory management and analytical techniques when needed.
Prepares written and verbal updates and findings, including slide presentations, and presents project updates.
Assists with the scheduling of resources. Drafts overall timeline for projects.
Supervises a laboratory or program with authority to make decision relevant to those programs.
Writes and reviews SOPs and maintains computer database of established protocols.
Maintains electronic and non-electronic records and adheres to GLP practices.
Bachelor's Degree in molecular biology, microbiology, biochemistry or related science/engineering field required. Master's or Doctoral degree, preferred.
Experience and Skillset:
Eight (8) years experience in GMP/GLP or equivalent regulated facility. Industrial experience is a plus.
Experience with genus and species identification of various microbes, applying GMP in QC Lab, implementing CAPA and initiating change control is desirable.
Knowledgeable in molecular biology techniques including mRNA, DNA extraction, RT-PCR, PCR, expression analysis.
Experience with maintenance of analytical and retain sample inventory logs under GMP compliance.
Must be well-organized, attentive to details with meticulous record keeping and a desire to ensure accurate results.
Working Title: Biomedical Scientist - 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.