Process Development and Manufacturing Associate
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 Associate is responsible for conducting experiments for process development, and assisting the technical transfer of GMP manufacturing method. Duties will involve performing daily clinical scale production of cellular therapies in support of clinical studies in a GMP facility, including but not limited to, processing human blood and tissue; establishing and maintaining cell cultures; cryopreservation, performing assays; compiling and analyzing data; preparing data summaries, charts, and graphs; operating analytical instruments; and documentation of all procedures.
Reporting Structure and Team
The Process Development and Manufacturing Associate reports to the VP of Research and is a key member of the Scientific Programs team.
Essential Job Functions
Key responsibilities will include, but not necessarily be limited to, the following:
- Perform experimentation to develop cellular processes to support the technical transfer of cellular manufacturing methods to clinical scale manufacturing of gene-edited cell therapy products
- Assist in data compilation, analysis, and drafting technical reports to support developed cellular processes for clinical manufacturing
- Following guidance from the Process Development and Manufacturing Lead to perform the daily clinical scale cGMP manufacturing within the GMP Facility
- Document all procedures extensively. Maintain careful records, compile and compute data from assays
- Bachelor’s degree or higher in a biological science with minimal 3 years of aseptic and mammalian cell culture, preferably including process development or GMP manufacturing experience for cellular therapies
- Experience with blood and cellular analytical methods such as cell counting, and multi-color flow cytometry
- Understanding of FDA, EMA and ICH regulations, industry standards and quality control principles for GMP operations
- Strong organizational skills with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment
- Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment