Role Purpose

To execute and support Drug Substance manufacturing operations by ensuring GMP‑compliant production processes, documentation accuracy, and coordination across functions to deliver consistent, high‑quality drug substance.

Role Description (Detail & Level‑Appropriate – Specialist)

Execute and technically support Drug Substance manufacturing processes (upstream and downstream) in accordance with approved SOPs, batch records, and GMP requirements.
Support operation and monitoring of DS production equipment (e.g. bioreactor, chromatography systems, UF/DF, process tanks) within validated parameters.
Review and verify batch records, logbooks, and production documentation for completeness, accuracy, and GMP compliance before submission.
Support process control, in‑process monitoring, and deviation identification during DS manufacturing activities.
Participate in and support process validation, scale‑up, and technology transfer activities for Drug Substance processes.
Support deviation investigation, root cause analysis, and CAPA implementation related to DS manufacturing.
Coordinate with QA, QC, Engineering, and Production Planning to ensure smooth execution of DS operations.
Support change control implementation related to DS processes, equipment, or materials.
Support audit and inspection readiness for DS manufacturing areas by ensuring documentation and process compliance.
Act as technical reference for DS Operators, providing guidance during routine operations and troubleshooting.

Production Drug Substance (DS) Specialist & Staff