Senior Analytical Method Transfer Lead (GMP/CMO)

CSL Plasma Inc.; Sankt Gallen; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

CSL Vifor in Switzerland is seeking an experienced analytical science professional focused on analytical method validation and transfer to CMOs/CDMOs under GMP conditions. You will coordinate method transfers, act as SME, and troubleshoot analytical challenges across external labs while ensuring alignment with regulatory dossiers.

You will report to the CMC Strategy and Technology Transfer Lead and collaborate with QA, Regulatory Affairs, and cross-functional teams to drive robust analytical

Qualifikationen

• Minimum 5 years in analytical development or quality control in pharma/biotech.
• Proven track record in method transfer and troubleshooting.
• Solid knowledge of GMP, ICH and ISO standards.

Aufgaben

• Lead and coordinate analytical method transfer activities to internal labs and CMOs/CDMOs.
• Act as SME for analytical issues during technology transfer and manufacturing.
• Troubleshoot analytical methods (HPLC/UPLC/GC/spectroscopy) in response to OOS/OOT.
• Support CMOs/CDMOs in establishing analytical methods and regulatory dossiers.
• Design, optimize, and validate methods per ICH and GMP in case of revalidation.
• Review transfer protocols, validation reports, and documentation.
• Drive root cause analysis and define CAPAs with cross-functional teams.
• Ensure method lifecycle management and continuous improvement.
• Support regulatory submissions with analytical sections (CTD Module 3).
• Interface between Technology Transfer, QA, Regulatory, and external partners.

Kenntnisse

Analytical method transfer

Troubleshooting

Root cause analysis

Cross-functional collaboration

Scientific problem solving

Regulatory compliance

Ausbildung

Degree in Chemistry or Pharmaceutical Sciences

5+ years in analytical development or quality control

GMP/ICH/ISO knowledge

Tools

HPLC

UPLC

GC

Spectroscopy

Dissolution

Jobbeschreibung

CSL Vifor in Switzerland is seeking an experienced analytical science professional focused on analytical method validation and transfer to CMOs/CDMOs under GMP conditions. You will coordinate method transfers, act as SME, and troubleshoot analytical challenges across external labs while ensuring alignment with regulatory dossiers.

You will report to the CMC Strategy and Technology Transfer Lead and collaborate with QA, Regulatory Affairs, and cross-functional teams to drive robust analytical