Cedars-Sinai Process Development Scientist - iPSC Biomanufacturing - Full-Time in Los Angeles, California
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.
Masters Degree in Biology or Life Sciences related field.
PhD in Biology or Life Sciences related field preferred.
For PhD. Minimum 5 years experience in Process Development in a GMP setting.
For Masters, Minimum 8 years experience in Process Development in a GMP setting.
Standing, walking, sitting, lifting, carrying, pushing, pulling, reaching, handling, grasping, feeling, talking, hearing, repetitive motions, eye/hand/foot coordination.
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.