cGMP Associate Director Process Development

Job Accountabilities:

• Develops and implements strategies that proactively identify and mitigate risks. Establishes strategic goals and objectives for product manufacturing operations. Enhances and supports crossfunctional interactions and activity prioritization. Regularly ensures compliance with all relevant regulatory requirements.
• Oversees the implementation of project plans (e.g. process and assay development and qualification) support tech transfer of processes to cGMP manufacturing and assays to QC. Develops and reviews SOPs protocols and technical reports.
• Works closely with internal/external stakeholders to ensure project success and competition. Coaches and develops staff and coordinates departmental hiring/staffing plans. Identifies improvement opportunities to optimize workflows and eliminate inefficiencies. Establishes metrics and reports on the state of cGMP operations to senior management.
• Participates in vendor management and qualification visits as needed. Attends regular meetings with management discussing progress reports facility needs and other required items.
• Ensures timely delivery of project goals and creates periodic progress reports summarizing status and potential risks. Assists with design and delivery of training courses. Stays current with new/emerging technologies and approaches leveraging the latest industry knowledge to facilitate opportunities for innovation and continuous improvement.
• 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. Creates staff development opportunities reads and contributes to journals and participates in professional organizations meetings conferences seminars and training courses.
• Lead process development and optimization efforts of cell therapy products including the design and production of viral vectors. Support assay development and qualification for product testing.
• Lead technology transfer to cGMP manufacturing and quality control ensuring efficient scaling and implementation. Develop and review SOPs protocols and process development reports. Authoring CMC documentation.
• Oversee lab setup and work with cGMP facility management to allocate resources and infrastructure for efficient project .
• 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:

Masters degree in a scientific discipline (e.g. pharmaceutical biologics). Four years of cellular or biological manufacturing experience (e.g. process development and analytical methods). Proven experience in leadership/management roles. Demonstrated experience in academic administration and quality management. Solid knowledge base in Good Manufacturing Practices (e.g. cGMPs GLPs GDPs) cellular and gene therapies translational research and the business of science. Demonstrated ability to work as an individual contributor and in dynamic team environments. Excellent written and oral communication skills.

This is a 3 year fixedterm position.

Salary:

The annual base salary range for this position is $130000 $140000. 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 candidatess 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.

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.

USC is an equal opportunity 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. USC observes affirmative action obligations consistent with state and federal law. 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 theBackground Screening Policy Appendix Dfor specific employment screen implications for the position for which you are applying.

We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone ator by email at. Inquiries will be treated as confidential to the extent permitted by law.

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