Process Development Scientist - GMP Biomanufacturing Center
Updated: May 17
Los Angeles
89.1
0mi
Job Abstract
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 (i. PSC) biology, bioprocessing, translational, regulatory... more details
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 Home - CSBIO (csbiomfg.com).
Are you ready to be a part of breakthrough research?
The Process Development (PD) Scientist provides scientific and technological leadership in the development and optimization of the cellular production process in the regenerative medicine field at various scales ranging from research &development (R&D) to current good manufacturing practices (cGMP) for phase I & II trials.
Primary Duties and Responsibilities:
Leads and performs technology transfer of research lab cellular and 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.
Ensuring 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, interpreting data, and writing technical reports, and SOPs. Work with R&D, cGMP manufacturing, and quality control (QC) teams for technology transfer of established production processes 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.
Leads and performs complex process development related activities to optimize and develop process for GMP manufacturing and assay development.
Initiates Design of Experiment (DOE) based approach to develop optimal process and ensures the consistency and reproducibility of the process.
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
Interprets complex research data and protocols and presents proposed SOP changes to clients.
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.
Provides on-site support to cGMP manufacturing production campaigns.
Represents the Process Development Department in Project Team meetings.
Education:
Masters Degree in Biology or Life Sciences related field is required. Doctorate Degree is preferred.
Experience and Skills:
Five (5) years of experience in Process Development within a GMP setting is required. Eight (8) years is preferred.
Plans, leads, and directs work of staff to ensure goals and objectives are completed within established budget and deadlines are met.
Supervises the day-to-day work of employees, assigns work, ensures tasks are completed and deadlines are met.
Establishes effective working relationships with cross-functional team(s).
Shares knowledge, time and expertise to assist other members of the team.
Working Title: Process Development Scientist - GMP Biomanufacturing Center Department: CS Biomanufacturing Facility Business Entity: Cedars-Sinai Medical Center Job Category: Biomanufacturing Job Specialty: Biomanufacturing Position Type: Full-time Shift Length: 8 hour shift Shift Type: Day Base Pay:$99,100.00 - $158,500.00
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