Associate Principal Scientist, Biologics Process R&D

**Job Description**

**Position Summary**

We are seeking a highly motivated and experienced **Associate Principal Scientist** to join our Cell Line Development group.

The successful candidate will also provide scientific and technical leadership for late-stage biologics programs with a focus on cell line development and cell banking-related regulatory strategy, filing authoring, and health authority response support. The ideal candidate will have strong hands-on and strategic experience with mammalian cell line development, late-stage CMC program support, regulatory filing authoring, and limit of in vitro cell age (LIVCA) studies.

The candidate will be responsible for ensuring that cell line development and cell bank characterization data packages are scientifically sound, and suitable to support global regulatory submissions. This role will serve as a key interface between Cell Line Development, Regulatory CMC, and cross-functional CMC program team...