Senior Process Engineer, MSAT

About this role

Responsibilities

• Lead the GMP implementation of internal platform processes for cell and gene therapy modalities, including upstream and downstream unit operations.
• Collaborate closely with Process Development to evaluate platform candidates, align on scalable manufacturing approaches, and ensure all platforms are structured to support CMC regulatory expectations for regulatory filings.
• Serve as a technical lead for technology transfer, validation, and lifecycle management initiatives.
• Contribute to CMC regulatory submissions by authoring and reviewing CMC module 3 sections, development summaries, and supporting data packages for applicable regulatory filings.
• Apply deep CMC knowledge to ensure internal platform processes align with current regulatory guidance (FDA, EMA, ICH Q8/Q9/Q10/Q11/Q12) and support the development of CMC content strategies.