Job Overview:
We are a leading biotechnology company dedicated to advancing the field of cell therapy. Committed to medical innovation, we strive to provide effective and safe treatment solutions for patients. With state-of-the-art laboratory facilities and a multidisciplinary team, we aim to propel the industry forward through cutting-edge research. We are seeking an experienced and innovative Senior Principal Scientist in Preclinical Safety (in vitro). This key leadership role focus on the development and execution of preclinical safety studies supporting cell-based therapies. The successful candidate will provide strategic and scientific expertise in designing, validating, and implementing in vitro safety assays that will inform the preclinical evaluation of novel cell therapy products.

Key Responsibilities:
61 Lead the design, development, and optimization of in vitro preclinical safety assays to evaluate the safety profile of cell therapy candidates.
61 Act as a subject matter expert (SME) in in vitro safety assays, collaborate with cross-functional teams, including research, toxicology, pharmacology, and bioanalytics, to ensure comprehensive safety assessments.
61 Provide scientific leadership in primary cell isolation, culture, and differentiation techniques to ensure the generation of high-quality, reproducible in vitro models.
61 Develop novel assay platforms to evaluate potential off-target or unintended cytotoxicity of therapeutic candidates, utilize advanced technologies (e.g. flow cytometry, immune assays, etc.) for downstream characterization.
61 Analyze and interpret data, communicate findings through reports and presentations.
61 Maintain up-to-date knowledge of regulatory guidelines (FDA, EMA) related to preclinical safety testing and ensure compliance in all assay development activities, providing guidance on regulatory submissions and contributing to Investigational New Drug (IND) applications.
61 Ensure project timelines, deliverables, and budgets are met, while continuously improving assay throughput and reliability.

Qualifications:
61 Ph.D. in Immunology, Cell Biology, or a related field with 6+ years of relevant experience within the cell therapy or related biotech/pharmaceutical industry.
61 Extensive experience with in vitro assays for assessing cell therapy safety, including primary cell killing or cytokine-dependent growth assays,
61 Proven expertise in cell culture, especially primary human cells, and experience with immune cells such as T cells, NK cells, or dendritic cells is required.
61 Proficiency in a variety of assay techniques such as flow cytometry, ELISA, PCR, immunofluorescence, and live/dead cell imaging.
61 In-depth understanding of cell therapy platforms, such as CAR-T, CAR-NK, or other engineered cellular products is highly desired.
61 Strong background in regulatory toxicology and experience supporting IND applications with preclinical data, experience working in a GxP or GLP-compliant environment.
61 Demonstrated ability to lead complex scientific projects and to work in a matrixed, multidisciplinary environment.
61 Excellent communication and presentation skills, with a proven track record of publications and presentations in the field.
61 Leadership experience, with the ability to mentor and guide junior scientists and foster a collaborative research environment.