Principal Scientist - Cell Therapy Process Development
Posted on Apr 6, 2021 by Atara Biotherapeutics, Inc.
This position will work with the Process Sciences teams to develop and characterize cell therapy manufacturing processes and products. The Principal Scientist will be responsible for developing new manufacturing platform technologies, designing closed system processes and automating manufacturing platforms to support Atara's T cell products. He/she will be responsible for Upstream process development and process characterization of scale-up/scale-down cell manufacturing processes. Under minimal supervision, you will be expected to design and perform experiments, organize and carefully document results, as well as analyze and interpret results, and communicate findings through presentations.
Individually contributing and leading a team of 2-3 Engineers/Scientists on development and optimization of upstream bioreactor processes
Become the Subject Matter Expert (SME) for bioreactor culture and operations for T-cell Manufacturing
Manage the design and execution of studies to establish operating and performance parameters (design space) for T cell manufacturing processes.
Performs gap analysis and risk assessments to identify problems and deficiencies, as well as provide recommendations for studies and solutions to manufacturing process.
Support the development of standard operating procedures, FMEA, batch records, and analytical sampling plans.
Education and Experience
PhD in a biological or engineering science with 5+ years of industry related experience, OR Master's Degree with 8+ years of related industry experience OR Bachelor's Degree with 10+ years of experience.
Knowledge and experience in mammalian cell culture/biotechnology related development (aseptic operations, cell biology, & upstream cell manufacturing processes).
Experience with process characterization, scale-up and closed system development.
Experience with process automation and high throughput data management in JMP.
Basic in-process analytical skills including the following techniques: multicolor flow cytometry, cell-based bioassays, etc.
Ability to follow laboratory procedures with attention to detail, and successfully execute experiments at the bench.
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
Demonstrated ability to manage project per timeline, maintain lab execution records and perform data analysis
Prior experience developing suspension bioreactor processes in cell therapy
Familiarity with development and/or commercialization of cell-based therapeutics
Basic understanding of cGMP requirements.
Experience using Design of Experiment (DOE) and JMP SAS software.
Experience in Biotech/API DeltaV batch applications.