Scientist, Analytical Science & Method Transfer

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

We are currently looking for an experienced analytical science professional specializing in analytical method validation and transfer to contract manufacturing organizations (CMOs/CDMOs). Strong focus on troubleshooting, root-cause investigation, and ensuring robust analytical performance across external laboratories and CMOs under GMP conditions. In this position you will be directly reporting to the CMC Strategy and Technology Transfer Lead.

Key Responsibilities

• Lead and coordinate analytical method transfer activities to or between Quality Control laboratories and external contract manufacturers
• Act as SME (Subject Matter Expert) 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

Core Expertise

• Analytical method transfer strategies (internal labs and CMOs)
• Analytical method development, validation, and lifecycle management
• Advanced analytical techniques:
• HPLC / UPLC
• GC
• Dissolution
• Spectroscopy
• Troubleshooting & deviation management (OOS/OOT investigations)
• Data evaluation
• GMP, ICH guidelines, and regulatory compliance

Professional Skills

• Experience working with contract manufacturers (CMOs/CDMOs) in a global environment
• Strong scientific problem-solving and troubleshooting mindset
• Excellent communication skills for interfacing with internal teams and external partners
• Structured and results-driven project management capabilities
• High level of accountability, persistence, and attention to detail
• Ability to manage multiple priorities in a regulated environment

Qualifications

• Degree in Chemistry, Pharmaceutical Sciences, or related field (e.g., HTL, ETH, MSc or equivalent)
• 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