Drug Substance(DS) Supervisor
SKPlasma Core Indonesia · KARAWANG, JAWA BARAT, ID
Sekilas tentang pekerjaan ini
SKPlasma Core Indonesia membuka posisi Drug Substance(DS) Supervisor untuk memimpin operasi fraksinasi plasma dan pemurnian protein serta memastikan produksi yang efisien dan sesuai GMP. Posisi ini berlokasi di Karawang, Jawa Barat.
Tugas utama
- Memimpin operasi fraksinasi plasma dan pemurnian protein end-to-end
- Mengelola produksi API dalam manufaktur biofarmasi
- Mengawasi kromatografi, UF/DF, reaktor, sistem filtrasi, dan sentrifugasi kontinu
- Memastikan prosedur filtrasi steril mematuhi standar GMP
- Membina operator serta menangani deviasi, analisis akar masalah, dan CAPA
Ringkasan ini dibuat dengan AI dari deskripsi di bawah. Yang berlaku adalah deskripsi lengkapnya di situs SKPlasma Core Indonesia.
Deskripsi pekerjaan
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).