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
o 1 year of relevant experience preferred (entry-level considered)
* or MSc in a relevant scientific field
o 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
*
o Strong understanding of laboratory best practices and data integrity principles
o Ability to work both independently and collaboratively in cross-functional environments
o Excellent communication skills, with English mandatory; German is an advantage
o Ability to work on-site with a maximum of 2 remote days per week
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