Your Tasks :
Analytical Method Lifecycle
Lead and execute project tasks related to method development, implementation, transfer, and validation .
Prepare and maintain test instructions, analytical methods, study plans, and technical reports according to internal quality standards.
Data Review & Documentation
Perform double-check and release of raw data and analytical results in LIMS.
Ensure data integrity and compliance in accordance with ISO and GMP requirements.
Laboratory Support
Provide expert technical support to the QC laboratory, including troubleshooting of analytical issues.
Independently plan, execute, evaluate, and document assigned tasks and projects.
Quality & Compliance
Manage and support Change Requests (CRs), Deviations (DRs), investigations (SST, OOX, etc.) and CAPAs .
Ensure full adherence to quality, safety, ISO, and GMP standards in all work processes.
Your Profile :
Education
PhD in Biotechnology, Biochemistry, Pharmaceuticals, or a related field
1 year of relevant experience preferred (entry-level considered)
or MSc in a relevant scientific field
Minimum 2 years of relevant experience required (laboratory or scientist roles)
Technical Skills
Hands-on experience with ELISA (focus on relative potency)
Hands-on experience with qPCR, including method development and / or validation
Data Review experience is important and strongly preferred
GMP experience is a plus
Other Requirements
Strong understanding of laboratory best practices and data integrity principles
Ability to work both independently and collaboratively in cross-functional environments
Excellent communication skills, with English mandatory ; German is an advantage
Ability to work on-site with a maximum of 2 remote days per week
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