The Process Development (PD) Scientist provides scientific and technique leadership in the development and optimization of cellular production process in regenerative medicine field at various scales ranging from research &development (R&D) to current good manufacturing practices (cGMP) for phase I & II trials.
Leads and performs 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. Provides guidance and applies 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.
Responsible for ensuring 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.
Ensures the preservation of cellular quality throughout the entire manufacturing process is critical to off-the-shelf cell therapies and will require the development of scalable operations.
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.
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.