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. 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 Scientist leads project development and compliance of all Federal and State accrediting agency including the Food and Drug Administration (FDA) requirements in good manufacturing practices (GMP) for cellular products in the CBC. As a Biomedical Scientist, perform process development, validation, and qualifications for cellular production in GMP / good laboratory practice (GLP) environment while providing guidance, technical expertise, and evaluating client processes to make recommendations for improvement. In this role, the Biomedical Scientist supervises a production team, tissue culture techniques, aseptic technique, and writing standard operating procedures (SOPs) for developing and processing clinical grade and research grade cellular products. Responsible for managing assigned projects and managing associates activities in regulated working environment, writing and recording controlled documents for assigned projects, and coordinating in assisting quality control team with all required testing activities. Provides excellent communication and must have an in-depth understanding of laboratory and research functions to ensure the success of projects. Primary Duties & Responsibilities: - Supervises and performs a variety of cGMP manufacturing production and process development projects for multiple clients following standard operating procedure for manufacturing processes that will be different for each project based on the type of cells, tissues or organs.
- Assists with cGMP manufacturing schedule and drafts overall timeline for projects as reference for finalizing manufacturing productions.
- Finalizes cGMP manufacturing production and process development reports and maintains computer database.
- Leads projects, trains and assists other manufacturing associates on day-to-day lab operations and procedures. Monitors performance, completes performance appraisals, and addresses performance issues. Performs and trains associates on all cGMP/ GLP related activities.
- Ensures all activities comply with regulatory guideline and safety standards by monitoring all ongoing activities and interacts regularly with QA and Regulatory Affairs.
- May develop hypothesis and assist in planning steps for the investigative process, reviewing and remaining current on literature as it relates to clinical/research study.
Department Specific 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 and 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 adheres to Federal and State accrediting agency requirements, including FDA requirements as necessary.
- Writes and reviews SOPs and maintains computer database of established protocols.
- Maintains electronic and non-electronic records and adheres to GLP practices.
- Identifies and responds appropriately to both internal and external customer needs utilizing available resources
- Collaborates to problem solve and make decisions to achieve desired outcomes
- Establishes effective working relationships with cross-functional team(s).
- Responds timely, effectively and appropriately to deliverables
- Shares knowledge, time and expertise to assist other members of the team
- Supervises the day-to-day work of employees, assigns work, ensures tasks are completed and deadlines are met.
- Responsible for hiring, onboarding, managing schedules, personnel actions, performance reviews, and performance improvement plans.
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