Location: Bulle, Switzerland ...
Jobdetails
Zusammenfassung
- Bulle, Freiburg
- UCB
- Temporär
veröffentlicht am 15. mai 2026
- Referenznummer
- 209836-298
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Laetitia Stirer
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Jobdetails
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.
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.
Qualifikationen
What will make you successful:
- Bachelor's or Master's degree in Chemistry, Pharmacy, or a related scientific field.
- Significant hands-on laboratory experience.
- Solid expertise in cGMP and pharmaceutical regulatory environments, with a focus on compliance and quality standards.
- Strong technical background in physicochemical analysis (HPLC, GC, dissolution, etc.) and Chromatography Data Systems.
- Proven ability to coordinate complex projects and manage cross-functional stakeholders between R&D and QC.
- Fluency in French (mandatory) with a strong command of English for technical writing and international documentation.
- Highly organized and solution-oriented, with a structured communication style and a proactive approach to troubleshooting.
We can offer you a new challenge in a diverse and innovative environment that gives temporary contrats the opportunity to step aside for a long period.
Have we sparked your interest? Then we look forward to receiving your online application.
