Unknown Company

GRA CMC Specialist

bridgeport, pa • Posted 1 weeks ago
Onsite Full Time Research & Development

CSL seeks a GRA CMC Specialist to support Chemistry, Manufacturing & Controls activities for biologics and gene therapy programs. In this role, you will compile and review CMC data from analytical, process, and formulation development teams, and translate findings into high‑quality regulatory documents for IND/IMPD/BLA submissions and responses. You will coordinate with Regulatory Affairs, QA, and Manufacturing to ensure compliance with global guidelines, maintain robust documentation and data integrity, and help manage timelines and risks in a collaborative, patient‑focused environment dedicated to life‑saving therapies.

GRA CMC Specialist in bridgeport at Unknown Company

This position is listed as full time and onsite.

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