cGMP Process Development (PD) Specialist

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 and 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 consideration. 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 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 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.

Salary Range:

The annual base salary range for this position is $93,900.53 - $100,000. 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 candidate's 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.

*This is a 3 year fixed-term position.

USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying.

Minimum Education: Master's degree
Minimum Experience: 3 years
Minimum Field of Expertise: Master's degree in a scientific discipline (e.g., pharmaceutical, biologics). Three years' experience in cellular or biological manufacturing and with process development and analytical methods. 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 Degree
Preferred Experience: 5 Years
Supervises: May lead one or more employees performing similar work.
Preferred Field of Expertise: Biotechnology and life sciences