Analytical Method Transfer Lead (GMP/CMO)

Phirm.ch; Glattbrugg; On-site; CHF 120,000 - 180,000; Full time

Job summary

Phirm.ch is seeking an experienced analytical science professional specializing in analytical method validation and transfer to CMOs/CDMOs under GMP conditions. You will report to the CMC Strategy and Technology Transfer Lead and drive method lifecycle management with internal and external partners.

The role focuses on troubleshooting, root-cause investigations, and ensuring analytical performance across external laboratories.

Qualifications

• Experience leading analytical method transfer to CMOs/CDMOs
• Strong troubleshooting and root-cause investigation skills
• Proficient in analytical methods (HPLC, GC, spectroscopy) and method lifecycle management

Responsibilities

• Lead and coordinate analytical method transfer activities to or between Quality Control laboratories and external contract manufacturers
• Act as SME for analytical issues during technology transfer and commercial manufacturing of drug substances and drug products
• Perform scientific troubleshooting for analytical methods (e.g., HPLC, GC, spectroscopy) in response to OOS, OOT, and atypical results
• Support CMOs/CDMOs in establishing analytical methods, resolving analytical challenges, ensuring alignment with internal standards and regulatory dossiers
• In case of method transfer by revalidation: design, optimize, and validate analytical methods according to ICH guidelines and GMP requirements
• Review and approve method transfer protocols, validation reports, and analytical documentation
• Drive root cause analysis and define CAPAs for analytical deviations in collaboration with cross-functional teams
• Ensure consistent method lifecycle management, including continuous improvement and robustness enhancement
• Support regulatory submissions by preparing and reviewing analytical sections (e.g., CTD Module 3) for new laboratories and CMOs
• Act as a key interface for Analytical Science & Method Transfer between Technology transfer team, Quality Assurance, Regulatory Affairs, and external partners

Skills

Analytical method transfer

HPLC/UPLC/GC

GMP compliance

Job description

Phirm.ch is seeking an experienced analytical science professional specializing in analytical method validation and transfer to CMOs/CDMOs under GMP conditions. You will report to the CMC Strategy and Technology Transfer Lead and drive method lifecycle management with internal and external partners.

The role focuses on troubleshooting, root-cause investigations, and ensuring analytical performance across external laboratories.