Description:
- The candidate would be in charge of the portfolio's end-to-end strategy and oversight of analytical development in a phase-appropriate way, utilizing both external and internal resources.
- Development, Qualification and Validation of all methods including Cell-Based Assays.
- Lead and inspire the creation, characterization, and documentation of robust potency/relative potency and analytical methodologies for CAR-T cell therapy and gene therapy products that are transferable (QC or CDMO receivers).
- Collaborate with a cross-functional team to improve genome-edited cell therapy initiatives, and encourage others to do the same.
Qualifications:
- Ability to lead and manage projects autonomously, as well as analyze and defend results.
- Strong experience in CAR-T cell-based assay and immunoassay development, including relative potency analysis, cellular signaling and metabolomics and immunological functional assays.
- Strong experience with GMP and regulatory aspects of assay requirements.
- Ability to mentor and motivate his/her direct and indirect reports to perform at a high level.
