The Cedars-Sinai Biomanufacturing Center (CBC) is a new cell manufacturing facility with world class expertise in stem cell (iPSC) biology, bioprocessing, translational, regulatory and manufacturing, which will provide a much-needed biomanufacturing center in Southern California. The CBC is committed to manufacturing the highest quality innovative cell and gene therapy products that meet or exceed our customer's requirements and expectations. We apply good scientific practices to provide diverse quality products and services. As dedicated partners in biomanufacturing, we strive to provide the highest levels of quality and safety of the manufactured products through robust and effective quality systems, process controls, rigorous performance criteria and testing.
As a Biomedical Scientist in the CBC, you will design, conduct, analyze and report studies that have been outlined by your supervisor or the Executive Director, and will actively propose new avenues of investigation to the Supervisor or Executive Director through investigation of the latest literature and new technologies.
Primary Duties and Responsibilities:
Proactively assigns projects, leads, and performs tasks, and writes standard operating procedures (SOPs).
Responsible for managing assigned projects and managing associates activities in a regulated working environment.
Writes and records controlled documents for assigned projects.
Supervises lab activities and is responsible for providing training to other individuals who may be assigned to the project, study, or laboratory.
Coordinates and assists quality control team with all testing activities where required.
May perform the duties of the Biomedical Technician and must have a thorough understanding of laboratory and research functions.
Reviews and remains current on literature as it relates to clinical/research study.
Responsible for completing successful qualifications and ongoing support procedures for clean room operations and assisting in the development, writing, and review of material specifications, standard manufacturing procedures, batch records and other GMP documentation.
Additional Duties and Responsibilities:
Supervises a laboratory or program with authority to make decision relevant to those programs.
Performs tasks related to the project and plans tasks, assigns work, monitors work, and identifies issues/problems, and makes plans to resolve problems.
Assists with the scheduling of resources.
Drafts overall timeline for projects.
Prepares written and verbal updates and findings, including slide presentations, and presents project updates.
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.
Maintains computer database of established protocols.
Maintains electronic and non-electronic records and adheres to GLP practices.
Monitors performance, completes performance appraisals, and addresses performance issues.
Performs and trains associates project related activities.
Ensures all activities comply with regulatory guidelines and safety standards by monitoring all on-going activities and interacts with other teams within the organization regularly.
Performs and supervises cell manufacturing related activities in an aseptic cGMP environment for different projects.
Leads projects, schedules cGMP manufacturing activities, assigns and monitors work of manufacturing associates. Drafts overall timeline for projects as reference for finalizing manufacturing productions.
Oversees the documentation of production operations in corresponding batch records and log books per established procedures ensuring accuracy and timely completion. Identifies real time manufacturing issues (deviations and atypical results), troubleshoots and communicates them to the Supervisor and the Quality team in a timely manner.
Ensures that manufacturing tasks are executed in compliance with the safety policies, quality systems, and GMP requirements.
Performs validation and process development runs using cell therapy equipment including but not limited to bioreactors, cell wash devices, CliniMACS and controlled rate freezer.
Helps with warehouse management, critical reagents and material inventory management.
Works with the Quality team to author out of specification (OOS) reports, deviation investigations and corrective and preventative actions.
Is responsible for manufacturing equipment maintenance, calibration and re-qualification.
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 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.