Lead, Analytical Method Transfer & Validation

CSL Plasma Inc.; Schweiz; Remote; CHF 100.000 - 150.000; Vollzeit

Zusammenfassung

CSL Plasma Inc. in Switzerland seeks an experienced analytical science professional focusing on analytical method validation and transfer to CMOs/CDMOs under GMP conditions.

You will report to the CMC Strategy and Technology Transfer Lead and lead activities across external laboratories. Responsibilities include coordinating method transfer between Quality Control labs and CMOs, acting as SME for analytical issues, troubleshooting methods (HPLC, GC, spectroscopy), and ensuring regulatory

Qualifikationen

• Degree in Chemistry, Pharmaceutical Sciences, or related field.
• Minimum 5 years of experience in analytical development or quality control within the pharmaceutical industry.
• Proven track record in method transfer and analytical troubleshooting.
• Solid knowledge of GMP, ICH, and ISO standards.

Aufgaben

• Lead analytical method transfer activities to Quality Control laboratories and external CMOs/CDMOs.
• Act as SME for analytical issues during technology transfer and manufacturing.
• Troubleshoot analytical methods (HPLC, GC, spectroscopy) in response to OOS/OOT results.
• Support CMOs/CDMOs in establishing analytical methods and resolving challenges.
• Design, optimize, and validate methods according to ICH guidelines and GMP requirements in revalidation scenarios.
• Review and approve transfer protocols, validation reports and documentation.
• Drive root cause analysis and CAPAs for analytical deviations with cross-functional teams.
• Ensure lifecycle management and continuous improvement of analytical methods.
• Assist regulatory submissions by preparing analytical sections (CTD Module 3) for new labs/CMOs.

Kenntnisse

Analytical problem-solving

Cross-functional collaboration

Regulatory documentation

Attention to detail

Communication

Ausbildung

Chemistry or Pharmaceutical Sciences degree

Tools

HPLC

UPLC

GC

Dissolution

Spectroscopy

Jobbeschreibung

CSL Plasma Inc. in Switzerland seeks an experienced analytical science professional focusing on analytical method validation and transfer to CMOs/CDMOs under GMP conditions.

You will report to the CMC Strategy and Technology Transfer Lead and lead activities across external laboratories. Responsibilities include coordinating method transfer between Quality Control labs and CMOs, acting as SME for analytical issues, troubleshooting methods (HPLC, GC, spectroscopy), and ensuring regulatory