Developing next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies
Requirements
- Demonstrated experience with scale-up and optimization of bioreactors for cell-based therapies
- Proven experience in GMP manufacturing setting, technology transfer (e.g., from academic institutions or to a third-party contract manufacturing organization (CMO)) and implementation of new technologies in a regulated environment (e.g., GMP, GLP, GxP)
- Experience with the assessment of new technologies, preferably in a cross-functional setting where impact of new technologies is evaluated across research, development and commercial organizations
- Demonstrated cell therapy experience
- Experience with scale-down model implementation and process characterization
- Highly proficient in using Microsoft Office (Word, Excel, PowerPoint) and data analysis software packages (Prism, Flow Jo, Spotfire, Geneious, etc)
Responsibilities
- Execute experiments to optimize process and product quality parameters, enhance cell therapy engineering and manufacturing capacity, apply Quality by Design (QbD) principles and Design of Experiment (DoE) methodologies, where appropriate
- Support cross-functional collaborations/projects with research, analytical and manufacturing stakeholders
- Collaborate with internal and external partners to evaluate new process technologies to develop next generation processes
- Support authorship of technical reports, regulatory documents and summaries of experiments and investigations
- Participate in authorship and review of batch records and SOPs
- Assist in the execution of comparability packages supporting the implementation of process changes
Other
- BSc in Biology, Immunology, Biotechnology, Bioengineering, or related field with a minimum of 7 years’ experience within the area of focus; or MSc in Biology, Immunology, Biotechnology, Bioengineering or related field with a minimum of 5 years’ experience within the area of focus
- Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities
- Excellent analytical skills and scientific/technical expertise
- Strong ability to work in a matrixed environment
- Effectively communicate, collaborate and discuss results with other scientists on the team
