職位描述
Key Responsibilities:
?Lead the design, development, and optimization of translational (e.g. ex vivo) assays to evaluate the clinical profile of cell therapy candidates.
?Contribute to translational strategies of novel gene and therapy products.
?Act as a subject matter expert (SME) in translational assays, such as ex vivo assays, collaborate with cross-functional teams, including research, preclinical, clinical, and bioanalytics, to ensure comprehensive translational assessments.
?Provide scientific leadership in CAR-T and patient sample-related immune cell isolation, culture, and differentiation techniques to ensure the generation of high-quality, reproducible and clinically relevant ex vivo models.
?Develop novel assay platforms to evaluate and address key translational questions therapeutic candidates, utilize advanced technologies (e.g. flow cytometry, immune assays, etc.) for translational characterization and deep dive.
?Analyze and interpret data, communicate findings through reports and presentations.
?Maintain up-to-date knowledge of innovative CAR-T and gene therapy competitive landscape and evaluation methods to drive translational efforts.
?Ensure project timelines, deliverables, and budgets are met, while continuously improving assay design, throughput, reliability and clinical relevance.
Qualifications:
?Ph.D. in Immunology, Cell Biology, or a related field with 1-5 years of relevant experience within the cell therapy or related biotech/pharmaceutical industry.
?Extensive experience with in vitro assays for assessing cell therapy safety, efficacy, MOA and other related attributes.
?Proven expertise in immune cell culture, such as (CAR-engineered) T cells, NK cells, or macrophages is required.
?Proficiency in a variety of assay techniques such as flow cytometry, ELISA, PCR and immunofluorescence.
?In-depth understanding of cell therapy platforms, such as CAR-T, CAR-NK, or other engineered cellular products is highly desired. Prior experience with in vivo CAR-T or gene therapy is a plus.
?Experience supporting IND applications with preclinical data, experience working in a GxP or GLP-compliant environment will be appreciated.
?Demonstrated ability to lead complex scientific projects and to work in a matrixed, multidisciplinary environment. Demonstrated project management skills to pursue multiple leads and to deliver.
?Demonstrated ability to think critically.
?Excellent communication and presentation skills, with a proven track record of publications and presentations in the field.
?Leadership experience, with the ability to mentor and guide junior scientists and foster a collaborative research environment.