Method Transfer & Validation Specialist

A global CDMO specialized in complex API manufacturing and purification technologies, with operations in southwest France, is urgently seeking an experienced Freelance Method Transfer & Validation Specialist for a 6-month assignment near Pau.

Key Responsibilities:

• Lead the transfer and validation of analytical methods from development to QC/industrial environments in accordance with ICH guidelines and GMP standards
• Act as technical liaison between internal analytical teams and international clients
• Coordinate project timelines and resource planning
• Supervise and support a team of 6 technicians: ensure testing execution, troubleshooting, and documentation are aligned with project timelines
• Review and approve method validation protocols, raw data, and analytical reports (validation, verification, transfer reports)
• Actively participate in root cause investigations, OOS/OOT assessments, and CAPA definition related to method performance
• Drive technical discussions around process understanding and industrial scale-up, in coordination with the industrialization and production teams
• Conduct or support hands-on testing as needed (e.g., robustness studies, system suitability, equipment qualification)
• Provide input on analytical strategy (e.g., lifecycle approach to method validation, control strategy alignment)

Ideal Profile:

• 10+ years of experience in analytical development, method transfer, and validation in a GMP-regulated pharmaceutical or biotech environment
• Solid expertise in HPLC/UPLC, GC, ICP, UV, FTIR, and detection techniques such as MS or HRMS (a plus)
• Proficiency with chromatography data systems (CDS) — ideally Empower (Waters), and lab data documentation systems
• Strong knowledge of ICH Q2(R2), Q8-Q10, and relevant pharmacopoeial methods
• Experience managing method lifecycle from development through validation, transfer, and routine QC
• Able to challenge analytical methods and results constructively — strong scientific and regulatory mindset
• Fluent in French and English, capable of navigating technical discussions in both languages
• Comfortable working in high-pressure environments, with minimal onboarding required
• Strong team leadership, planning, and communication skills — dynamic and pragmatic in day-to-day execution

What We Offer:

• Competitive daily freelance rate
• Opportunity to contribute to a major CDMO’s strategic industrialization project
• 6-month contract based near Pau, with potential for extension
• Start date: ASAP

For further details or to apply, please send your CV or reach out via direct message. Due to the urgency of the assignment, we aim to begin interviews shortly.

Disclaimer:

Amoria Bond is an independent recruitment consultant specializing in sustainable recruitment. None of the terms used in this advert are (in)directly intended to exclude candidates on the basis of age and experience. We hereby confirm that we are accepting applications from suitable candidates regardless of age and experience.