cGMP Process Development Specialist

cGMP Process Development Specialist

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Location : Los Angeles, CA - Health Sciences Campus

Time Type : Full time

Posted on : Posted Yesterday

Job Requisition ID : REQ20145450

The University of Southern California (USC)

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 activities, and supporting the development of assays for product characterization.

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 for 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.

Minimum Requirements

Minimum Education :

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Master's degree or equivalent in a related field.

Minimum Experience :

3 years in cellular or biological manufacturing with process development and analytical methods.

Minimum Skills :

Experience manufacturing scale processes using various cell culture platforms (e.g., Cell Factories, G-Rex’s, Bioreactors) 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. Excellent written and oral communication skills.

Preferred Qualifications

Preferred Education :

Doctorate in Biotechnology or related field.

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 is an equal opportunity, affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy.

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