Keck School of Medicine
cGMP Process Development Specialist
Keck School of Medicine, Irvine, California, United States, 92713
The University of Southern California (USC), founded in 1880, is located in the heart of downtown L.A. and is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the “Trojan Family,” which comprises the faculty, students, and staff that make the university what it is.
USC’s Keck School of Medicine is seeking a dynamic individual to work on the process development and manufacturing of cell and gene therapies and other biological products for internal/external users in the university’s current Good Manufacturing Practices (cGMP) facility. The Process Development Specialist is responsible for developing procedures and methods to produce multiple cell and gene therapy products, identifying equipment and components necessary for cGMP production, implementing necessary changes to the process and reagents for cGMP compliance, executing technology transfer activates, identities, and supports the development of assays for product characterization. The position will also be responsible for establishing viral and nonviral vector platforms under cGMP conditions.
Job Accountabilities
Responsible for leading process development, optimization, and scale-up activities for the manufacture of cell therapies and biologics. Establishes and executes development project plans (e.g., process and assay development, assay qualification, support tech transfer of processes) from cGMP manufacturing and assays to quality control. Develops and reviews standard operating procedures (SOP), protocols process development, and technical reports.Sets up labs for process development work (e.g., purchases and installs equipment, establishes lab SOP). Participates in vendor management and qualification visits as needed.Provides technical direction and training for process development activities based on clinical manufacturing and cGMP design considerations. Serves as a resource to cGMP facility management in identifying and assessing the appropriate complement of resources and support needed to successfully implement and execute projects. Provides training support to the manufacturing and quality control teams during tech transfer.Designs and produces viral vectors and characterizes them by performing varied in vitro and in vivo assays. Supports in-process testing, product characterization, final product release, and comparability testing. Generates Chemistry, Manufacturing, and Control (CMC) documents for Investigational New Drug (IND) applications. Generates validation plans for new products. Works with senior staff to ensure facilities' compliance with all applicable regulations.Designs, executes, summarizes, and presents process development studies while maintaining good documentation practices. Performs gap analyses and risk assessments to identify problems and deficiencies. Provides recommendations for studies and solutions to manufacturing process issues. Attends routine meetings with the management team for progress reports on projects, facility needs, and discussion of any other required items.Promotes an environment that fosters inclusive relationships and creates unbiased opportunities for contributions through ideas, words, and actions that uphold the principles of the USC Code of Ethics.Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.Successful Candidates Must Demonstrate:
Degree in a directly related specialized scientific field. Demonstrated knowledge of all aspects of biotechnology and cell therapy. Demonstrated passion for solving complex scientific issues. Experience with Food and Drug Administration regulations and clinical trials. Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.
The annual rate range for this position is $94,000 - $106,932. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidates' work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.Minimum Education: Master's degree Or Master's degree Pharmacy Or Master's degree Biology Or Master's degree in related field(s) Minimum Experience: 3 years in cellular or biological manufacturing and with process development and analytical methods Minimum Skills: Experience manufacturing scale processes using various cell culture platforms (e.g. Cell Factories, G-Rex’s, Bioreacotrs) and equipment (e.g., CliniMACS Prodigy, CliniMACS Plus, LOVO). Demonstrated knowledge base with Good Manufacturing Practices (e.g., cGMPs, GLPs, GDPs). Experience with standard operating procedures in a cGMP laboratory setting. Demonstrated ability to work as an individual contributor and in a dynamic team environment. Excellent written and oral communication skills. Preferred Education: Doctorate Biotechnology Or Doctorate in related field(s) Preferred Skills: Demonstrated knowledge of all aspects of biotechnology and cell therapy. Demonstrated passion for solving complex scientific issues. Experience with Food and Drug Administration regulations and clinical trials. Extensive leadership experience.
USC’s Keck School of Medicine is seeking a dynamic individual to work on the process development and manufacturing of cell and gene therapies and other biological products for internal/external users in the university’s current Good Manufacturing Practices (cGMP) facility. The Process Development Specialist is responsible for developing procedures and methods to produce multiple cell and gene therapy products, identifying equipment and components necessary for cGMP production, implementing necessary changes to the process and reagents for cGMP compliance, executing technology transfer activates, identities, and supports the development of assays for product characterization. The position will also be responsible for establishing viral and nonviral vector platforms under cGMP conditions.
Job Accountabilities
Responsible for leading process development, optimization, and scale-up activities for the manufacture of cell therapies and biologics. Establishes and executes development project plans (e.g., process and assay development, assay qualification, support tech transfer of processes) from cGMP manufacturing and assays to quality control. Develops and reviews standard operating procedures (SOP), protocols process development, and technical reports.Sets up labs for process development work (e.g., purchases and installs equipment, establishes lab SOP). Participates in vendor management and qualification visits as needed.Provides technical direction and training for process development activities based on clinical manufacturing and cGMP design considerations. Serves as a resource to cGMP facility management in identifying and assessing the appropriate complement of resources and support needed to successfully implement and execute projects. Provides training support to the manufacturing and quality control teams during tech transfer.Designs and produces viral vectors and characterizes them by performing varied in vitro and in vivo assays. Supports in-process testing, product characterization, final product release, and comparability testing. Generates Chemistry, Manufacturing, and Control (CMC) documents for Investigational New Drug (IND) applications. Generates validation plans for new products. Works with senior staff to ensure facilities' compliance with all applicable regulations.Designs, executes, summarizes, and presents process development studies while maintaining good documentation practices. Performs gap analyses and risk assessments to identify problems and deficiencies. Provides recommendations for studies and solutions to manufacturing process issues. Attends routine meetings with the management team for progress reports on projects, facility needs, and discussion of any other required items.Promotes an environment that fosters inclusive relationships and creates unbiased opportunities for contributions through ideas, words, and actions that uphold the principles of the USC Code of Ethics.Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.Successful Candidates Must Demonstrate:
Degree in a directly related specialized scientific field. Demonstrated knowledge of all aspects of biotechnology and cell therapy. Demonstrated passion for solving complex scientific issues. Experience with Food and Drug Administration regulations and clinical trials. Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.
The annual rate range for this position is $94,000 - $106,932. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidates' work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.Minimum Education: Master's degree Or Master's degree Pharmacy Or Master's degree Biology Or Master's degree in related field(s) Minimum Experience: 3 years in cellular or biological manufacturing and with process development and analytical methods Minimum Skills: Experience manufacturing scale processes using various cell culture platforms (e.g. Cell Factories, G-Rex’s, Bioreacotrs) and equipment (e.g., CliniMACS Prodigy, CliniMACS Plus, LOVO). Demonstrated knowledge base with Good Manufacturing Practices (e.g., cGMPs, GLPs, GDPs). Experience with standard operating procedures in a cGMP laboratory setting. Demonstrated ability to work as an individual contributor and in a dynamic team environment. Excellent written and oral communication skills. Preferred Education: Doctorate Biotechnology Or Doctorate in related field(s) Preferred Skills: Demonstrated knowledge of all aspects of biotechnology and cell therapy. Demonstrated passion for solving complex scientific issues. Experience with Food and Drug Administration regulations and clinical trials. Extensive leadership experience.