Lead, Analytical Method Transfer & CMO Compliance

CSL Vifor; Sankt Gallen; Vor Ort; CHF 95.000 - 135.000; Vollzeit

Zusammenfassung

CSL Vifor is seeking an experienced analytical science professional focused on analytical method validation and transfer to CMOs/CDMOs, with a strong emphasis on troubleshooting, root-cause investigations, and maintaining robust analytical performance under GMP conditions.

You will report to the CMC Strategy and Technology Transfer Lead and drive method transfer, develop and validate methods (ICH/GMP), review protocols and validation reports, and support regulatory submissions with accurate

Qualifikationen

• Minimum 5 years of analytical development or QC experience in the pharmaceutical industry.
• Experience with method transfer and analytical troubleshooting.
• Solid knowledge of GMP, ICH, and ISO standards.
• Experience working with CMOs/CDMOs in a global environment.

Aufgaben

• Lead and coordinate analytical method transfer activities to or between QC laboratories and external CMOs/CDMOs.
• Act as SME for analytical issues during technology transfer and manufacturing.
• Troubleshoot analytical methods (e.g., HPLC, GC, spectroscopy) for OOS, OOT, and atypical results.
• Support CMOs/CDMOs in establishing analytical methods and regulatory alignment.
• Design, optimize, and validate methods according to ICH and GMP when revalidating.
• Review and approve transfer protocols, validation reports, and analytical documentation.
• Drive CAPAs for analytical deviations with cross-functional teams.
• Ensure method lifecycle management and continuous improvement.
• Support regulatory submissions by preparing analytical sections (CTD Module 3).
• Interface between Analytical Science & Method Transfer and QA, Regulatory, and partners.

Kenntnisse

Analytical method transfer

Troubleshooting

Root cause analysis

HPLC/UPLC

GC

Spectroscopy

Quality systems

Regulatory knowledge

Cross-functional collaboration

Documentation

Ausbildung

Degree in Chemistry or Pharmaceutical Sciences

MSc or equivalent

Tools

LIMS (Laboratory Information Management System)

CTD familiarity

Jobbeschreibung

CSL Vifor is seeking an experienced analytical science professional focused on analytical method validation and transfer to CMOs/CDMOs, with a strong emphasis on troubleshooting, root-cause investigations, and maintaining robust analytical performance under GMP conditions.

You will report to the CMC Strategy and Technology Transfer Lead and drive method transfer, develop and validate methods (ICH/GMP), review protocols and validation reports, and support regulatory submissions with accurate