Cedars-Sinai Process Development Scientist - Stem Cell Biomanufacturing in West Hollywood, California
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.
To learn more about the CBC, please visit: https://www.cedars-sinai.org/research/areas/biomanufacturing/about.html
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.
Additional 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
#Jobs-HERC #Jobs-LinkedIn #Jobs-Indeed
Education we are looking for:
Masters Degree in Biology or Life Sciences related field, required
PhD in Biology or Life Sciences related field, preferred
Process Development in a GMP setting experience required with:
5 years of experience for PhD's
8 years of experience for Masters
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.