Process Development and Manufacturing Scientist
Scientific Programs | San Francisco, Ca | Full Time
The Parker Institute for Cancer Immunotherapy (PICI) is an unprecedented collaboration between the country’s leading immunologists and cancer centers — Memorial Sloan Kettering Cancer Center, Stanford Medicine, the University of California, Los Angeles, the University of California, San Francisco, the University of Pennsylvania and The University of Texas MD Anderson Cancer Center — for the first time unifying the research programs, intellectual property licensing, data collection, and clinical trials across multiple centers under the umbrella of a single nonprofit biomedical research organization. PICI was created through a $250 million grant from The Parker Foundation.
PICI’s goal is to accelerate the development of breakthrough immune therapies capable of turning cancer into a curable disease by ensuring the coordination and collaboration of the field’s top researchers, and quickly turning their findings into patient treatments. The Institute is based in San Francisco, California and was publicly announced in April 2016.
Key to the success of this effort will be the planning and implementation of clinical trails conducted at one or more member institutions as well as a network of sites external to the consortium, as appropriate.
Description of Duties
The Process Development and Manufacturing Scientist is responsible for leading the process development, and cGMP manufacturing activities in the production of cellular and gene therapies in support of clinical studies. The focus of this role includes the planning and execution of process manufacturing experiments to support an IND filing. This includes leading the initial clinical manufacturing initiatives and clinical scale manufacturing in the GMP facility. Additionally, this individual will assure all processes are developed in compliance with FDA, EU and international regulatory agencies, author process-related SOPs, CMC sections of INDs and other regulatory filings, and maintain a constructive and cooperative relationship with Quality Systems. The role requires strong working knowledge of cellular manufacturing processes as well as experience across CMC functions with a focus on process development. The successful candidate must have successfully demonstrated technical proficiency, scientific creativity, initiative, independent thinking and collaboration with others.
Reporting Structure and Team
The Process Development and Manufacturing Scientist will report to the VP, Research and work closely with the VP, Clinical Development.
Essential Job Functions
Key responsibilities will include, but not necessarily be limited to, the following:
- Provides subject matter expertise in cell processing technology development for manufacturing of cell therapies within a GMP manufacturing environment
- Develops project plans and timelines for process development, process technology transfer and GMP manufacturing start-up for multiple cell therapy development projects, and manage activities through to punctually achieving goals
- Responsible for daily activities required for successful production of cellular product in the GMP facility including ensuring batch production activities follow all documentation and Standard Operating Procedures (SOPs)
- Responsible for cGMP compliance, ensuring that all production equipment is properly working and production processes meet quality standards.
- Oversees, and provides leadership for process development and clinical manufacturing functions in cross-functional team forums
- Hires, supervises, and mentors staff and their reports
- Advanced degree in a biological science with minimal 5 years of relevant experience in cell therapy development and manufacturing
- Direct experience in aseptic processing techniques and a thorough understanding of cell therapy/gene therapy clinical manufacturing
- Breadth of knowledge across cell culture technologies, cell processing technologies, cell characterization methods, manufacturing under cGMP, validation, Quality Systems and regulatory requirements.
- Experience authoring SOPs, CMC sections of regulatory documents
- Familiarity with and constant attention to the evolving landscape through the literature, conferences, etc
- Supervisory experience and skills