analytical transfer and qc readiness expert.

Location: Bulle, Switzerland

Activity rate : 100%

Type of contract: Temporary contract (until 31.12.2026 with a potential extension)

Start Date: ASAP

In this role, you will act as the bridge between development and production, ensuring the successful transfer and implementation of analytical methods within a strictly regulated pharmaceutical cGMP environment. You will focus on coordination, documentation, and technical expertise without performing routine laboratory testing.

Your key responsibilities:

• Coordinate the transfer, validation, and verification of physicochemical methods (HPLC, GC, UV, KF, dissolution) in compliance with cGMP and regulatory standards.
• Draft and review all lifecycle documentation, including validation plans, protocols, risk assessments, and final reports.
• Act as the technical SME for investigations, Change Controls, and continuous improvement projects.
• Lead the global transfer strategy and manage post-transfer activities until the full commissioning of methods in the QC laboratory.
• Present and defend analytical validation and transfer documentation during health authority inspections and partner audits.
• Transfer technical knowledge to QC teams through dedicated coaching and training on new analytical methods.
• Serve as a Key User for the Chromatography Data System (CDS) and support laboratory software administration.
• Oversee the acquisition of new laboratory equipment, including procedure writing and user training.
• Provide expert troubleshooting support for new equipment and ensure the general smooth running of laboratory operations.