Our client in the Biotech industry is dedicated to quality and driven by excellence, they are committed to improving the lives of patients worldwide. They are steadfast in their goal to develop innovative cellular therapies that bring them closer to a cure.
Today, their research is focused on continuous innovation in the field of cell therapy. They are also future-focused on emerging technologies that can help address some of the most chronic and life-threatening diseases.

They are hiring a (Associate) Director of Bioanalytical and Translational Science in Nanjing city, JiangSu Province, China. 

Responsibilities 

• Provide scientific leadership, and line management to Company’s Bioanalytics function
• Supervise the development, validation and implementation of state of the art bioanalytical assays (PK, PD, Immunogenicity, and biomarker) to support Company’s CAR-T programs and emerging new technology platforms.
• Supervise assay transfer to CROs and sample analysis from GLP preclinical and clinical studies.
• Establish and maintain effective bioanalytical outsourcing strategy and vendor relationships for bioanalytical sample analysis and assay development where required
• Have overall responsibility for the technical bioanalytical conduct of studies/projects, as well as for interpretation, analysis, documentation and reporting of results.
• Manage bioanalytical labs and assure quality of raw data in compliance with the guidelines (SOP, GLP, EHS, Company policies, etc.).
• Maintain good knowledge of relevant novel assay technologies/ principles/ protocols and good understanding of closely related areas.
• Identify complex problems (e.g. overall raw data quality, inconsistency of data/results, appropriateness of study design/approach/technology) and propose creative and workable solutions.
• Write SOP’s, guidelines and policies in own area where appropriate; write and review technical and summary document for regulatory filings (IB, IND/IMPD, BLA/MAA etc.) independently.
• Lead and maintain close collaborations with corporate collaborators.
• Present scientific/technical work at internal/external meetings.
• Publish externally as major contributor if business needs; write patent applications; review current literature in own discipline.

Requirements

• PhD in immunology, analytical sciences or related field, plus minimum of 5 years relevant experience. Late stage development and commercial experience preferred.
• Experience with diverse biotherapeutics portfolio especially on CAR-T and cell therapy products are highly desirable.

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