JOB DESCRIPTION

Job title :

Lead –

CMC Biopharmaceuticals | (Gene Therapy)
Reports to :

VP - Operations

Job purpose
The Lead – CMC will provide technical and regulatory leadership for Chemistry, Manufacturing & Controls (CMC) activities supporting cell therapy, gene therapy, and advanced biopharmaceutical products intended for US FDA regulatory submissions and commercialization. This role will lead end-to-end CMC strategy, process development, GMP manufacturing support, and regulatory authoring for IND, BLA, and post-approval submissions. The position requires strong expertise in FDA expectations for biologics, viral vectors, and advanced therapy medicinal products (ATMPs), including lifecycle management, comparability, validation, and inspection readiness.

The ideal candidate will have extensive experience of manufacturing process of biologics and advanced therapies

with a strong understanding of 21 CFR regulations, ...