Category

Description

Provide reviews and approvals for laboratory related issues, projects and documents, to support cell therapy product development, manufacture, technology transfer, and continuous improvement
Provide expertise related to cell-based potency, HPLC, and molecular methods
Support microbiology techniques and validations, including bioburden, Mycoplasma molecular detection, microbiological identification, environmental monitoring and sterility for biologics
Provide Laboratory and Quality System requirements for laboratories which support cell therapy products produced by or for Takeda, ensuring these systems are aligned with unique ATMP requirements of cell therapy products
Assure efficient and effective resolution of critical product quality/compliance issues identified internally or by customers across the internal and CMO network, including the ability to provide timely QC support to assist with the root cause investigations and corrective

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