Method Transfer & Validation Specialist

Amoria Bond; Pau; Sur place; EUR 60 000 - 100 000; Plein temps

Résumé du poste

A forward-thinking company is seeking an experienced Freelance Method Transfer & Validation Specialist for a pivotal 6-month project near Pau. This role involves leading the transfer and validation of analytical methods in a GMP-regulated environment, ensuring compliance with ICH guidelines. The ideal candidate will have over 10 years of experience in analytical development, strong expertise in various analytical techniques, and the ability to lead teams effectively. This is an excellent opportunity to contribute to a major CDMO’s strategic industrialization project while enjoying a competitive freelance rate and the potential for contract extension.

Prestations

Competitive daily freelance rate

Opportunity to contribute to strategic projects

Potential for contract extension

Qualifications

• 10+ years in analytical development and validation in GMP environments.
• Fluent in French and English for technical discussions.

Responsabilités

• Lead method transfer and validation in compliance with GMP standards.
• Supervise a team of 6 technicians and coordinate project timelines.

Connaissances

HPLC / UPLC

GC

ICP

UV

FTIR

MS or HRMS

Analytical Method Validation

Team Leadership

Communication Skills

Project Management

Formation

PhD in Chemistry or related field

Outils

Empower (Waters)

Chromatography Data Systems (CDS)

Description du poste

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.

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.