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We are seeking a skilled and experienced scientist to support our expanding Preclinical Cell Therapy program which extends to exploratory clinical assay development. The successful candidate will work with several groups including our commercial partners to implement the most appropriate assays towards the development of new cell and gene therapy programs, to support IND-enabling studies, and transfer assays supporting early phase clinical studies. In this capacity, you will drive the design, development, execution and analyses of assays that span preclinical-to-early clinical studies. These will include iPSC differentiation, flow cytometry, cytokine/chemokine quantification, and other phenotypic / functional assays for cell health, 2D and 3D cell culturing, and multiple cell-type specific assays for hepatocytes, neurons and T-cells.

Key Responsibilities:

• Manage the qualification/validation and implementation of key assays to support IND-enabling studies in support of preclinical development.
• Manage the transfer, validation/qualification and implementation of exploratory assays to support early phase clinical studies.
• Review and analyze assay data for assurance of assay quality and consistency.
• Work with other group leaders to prepare data presentations and relevant updates to cross-functional teams.
• Possess excellent organizational skills, with the ability to multi-task in an extremely fast-paced environment.

Requirements:

• Strong scientific background in a relevant field (Biology, Biochemistry, Immunology, other), PhD with 4+ years of relevant experience or MSc with 8+ years of relevant experience within the biopharmaceutical industry.
• Strong experience with assay development, particularly experience in qualification and validation of bioassays, e.g. biomarkers, flow cytometry, cell-based methods, molecular methods, PD, PK, , ADA and laboratory developed tests (LDT).
• Significant experience and working knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
• Experience managing direct reports and outside vendors as well as the ability to work successfully in a team-oriented environment

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We are seeking a lab manager with 1-3 years experience to oversee the day to day reagent requirements, assembly line production and animal work. Cell culture work experience is required along with a BA in biology or related science. MA in biology or biochemistry is preferred.