The Associate Director will have overall responsibility for leading and managing a dynamic team developing advanced analytics supporting cell therapy pipelines. The ideal candidate will assume a key leadership role in the development of analytical strategies and will be expected to implement on platform evaluation, deep characterization of cell therapy products, CQA assessments, etc. in early stage clinical manufacturing, product release testing, and product characterization. The individual will work to build, manage, and mentor a strong technical team to deliver key data, documentation, and knowledge transfer.
- Provide strategic, technical and scientific leadership to the analytical development team
- Accountable for advanced analytical capabilities buildup and team management
- Lead and manage analytical activities for extended characterization of cell therapy products
- Oversee assay development activities from conception through, optimization, qualification, and method transfer to quality control
- Serve as SME and technical advisor on ICH method validations, method transfers, comparability/bridging protocols
- Author, review and approve technical reports, analytical documents (e.g., analytical methods and associated protocols, SOPs, etc.) and incorporate regulatory documents.
- Accountable for developing and executing Cell Therapy CMC strategies to enable and deliver IND and BLA filings.
- Collaborate closely with other key line functions and communicates complex data/decisions within department and cross functionally
- Responsible for integrating scientific/technical efforts around cross-functional issues
Education, Experience and Skills
- PhD in relevant scientific discipline (such as Biotechnology, Immunology, Molecular Biology, Biochemistry, Bioinformatics)
- 10+ years of relevant industry experiences.
- Excellence and successful track record in leadership, people management and managing interfaces with other functions and integrated teams.
- Proven track record and demonstrated deep understanding of pharmaceutical drug development, program and project development
- Significant prior experience in driving characterization of cell and gene therapy products
- Deep understanding in advanced analytical platforms and method development/qualification/validation of CAGT methods including cell-based assays, cytotox assays, flow cytometry and/or single cell molecular assays
- Prior experience with IND, NDA or BLA desirable