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?
As a Process Development Scientist, provide scientific and technique leadership in the development and optimization of the cellular production process in the regenerative medicine field at various scales ranging from research and development (R&D) to current good manufacturing practices (cGMP) for Phase I & II trials. Be a leader and perform technology transfer of research lab cellular rand gene therapy manufacturing processes and converts them to c-GMP compatible processes with appropriate scale up or scale out. Provide guidance and apply intricate knowledge of allogeneic processes where significant scale-up is required as well as patient-specific cell therapies (autologous) for process scalability, where the manufacturing process must be scaled-out. Your responsibility is to ensure that the desired quality and target product profile of the cell is maintained through the entire manufacturing process, including the harvest, downstream processing, and delivery while also ensuring the preservation of cellular quality which is critical to off-the-shelf cell therapies and will require the development of scalable operations.
Primary Duties and Responsibilities:
Responsible for reading literature and creating innovative methods and intellectual property for developing GMP-compatible processes for cellular therapies, especially related to Induced Pluripotent Stem Cells (iPSCs) and their differentiated derivatives
Utilizes strong laboratory skill sets to design and execute experiments with a focus on process establishment and robustness, assay development, interpret data, write technical reports, and SOPs
Work with R&D, cGMP manufacturing, and quality control (QC) teams for technology transfer of established production process as well as on-site support to cGMP manufacturing production campaigns
Provides leadership for supervising associates and ensures the compliance of the facility's standard operating procedures (SOPs) and policies which incorporate both internal and external (i.e. FDA) regulatory standards.
Advises and ensures all optimization processes are properly designed and controlled with appropriate testing plans
Provides guidance and cGMP expertise to associates to conduct necessary approaches for mentoring and the success of projects
Develops new products and processes related to cellular based therapies
Performs analysis and optimizes performance of manufacturing systems and improves efficiency of manufactured products
Writes standard operating procedures (SOPs) and reports for developed processes
Prepares and presents the development process to internal teams and external clients
Collects data, prepares and participates in writing manuscript for publication
Provides scientific and technical knowledge to establishment process development and optimization
Designs and executes experiments, conducts assay development, interprets data, writes technique reports, and generates SOPs
Communicates with multiple teams, R&D, manufacturing, and QC teams for technology transfer
Masters Degree in Biology or Life Sciences related field, required
PhD in Biology or Life Sciences related field, preferred
Experience and Skillset:
Five (5) years of experience required. Eight (8) years of experience, preferred.
Ability to convey and/or receive written/verbal information to/from various audiences in different formats
Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations
Ability to apply critical thinking to analyze and interpret information and/or data
Working Title: Process Development Scientist - Stem Cell Biomanufacturing
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.