Drug Substance(DS) Supervisor

Role Purporse

To lead and ensure the effective, compliant, and efficient execution of plasma fractionation and protein purification operations by managing drug substance (API) manufacturing processes, driving operational excellence, and ensuring GMP-compliant production through strong leadership, cross‑functional collaboration, and continuous improvement.

Role Description

• Lead and oversee end‑to‑end plasma fractionation and protein purification operations.
• Manage API (Active Pharmaceutical Ingredient) production activities within biopharmaceutical manufacturing.
• Supervise, operate, and optimize chromatography and ultrafiltration/diafiltration (UF/DF) processes for protein purification.
• Oversee and manage large‑scale reactors, filtration systems, and continuous centrifuges used in DS manufacturing.
• Ensure sterile filtration procedures are conducted in full compliance with GMP standards.
• Provide leadership, training, and performance management for production operators.
• Coordinate cross‑functional collaboration with QA, QC, Engineering, and R&D for smooth operational execution.
• Drive continuous improvement initiatives in production processes, documentation, and operational efficiency.
• Manage deviation handling, root‑cause analysis, and corrective/preventive actions (CAPA).

Required

• Bachelor’s degree in pharmacy or equivalent fields (Biology, Chemistry, etc.)
• Minimum 5 years working experience in performing, managing, and manufacturing DS processes within the pharmaceutical industry (for manager position, minimum 13 years working experiecne is required)
• Proficiency in English (both written and spoken)

Preferred

• Experience in fractionation & protein purification processes within the biopharmaceutical industry
• Experience in the initial setup of fractionation & purification processes in a newly constructed biopharmaceutical facility
• Having Pharmacist License (STRA)

• Multinational Company Environment
• SK Management Work Culture
• Lunch & Snack Box
• Shuttle Bus
• Social Insurance Fully Paid by Company