Scientist (m/f/d) (Protein Biomarker Assay Development and Validation)

CENTOGENE GmbH; Rostock; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

German language courses

Zusammenfassung

CENTOGENE GmbH in Rostock, Germany, is seeking a highly skilled scientist to lead assay development and validation for protein-based biomarker assays, including ELISA and proximity extension assays. You will design studies, build workflows, and write validation documents.

You will work with R&D, QA and external partners, analyze data using Excel, GraphPad Prism, R or Python, and apply GLP/GCLP standards. Fluent English required; German at A2 and willingness to improve.

Qualifikationen

• PhD in Biochemistry, Molecular Biology or a related field.
• Strong background in protein-focused biochemistry.
• Hands-on laboratory experience developing/validating protein assays (immunoassays).
• Familiarity with GLP/GCLP environments.
• Confident data analysis with Excel and GraphPad Prism, and experience with R and/or Python.
• Fluent English, written and spoken; German at A2 level or higher and willingness to improve.

Aufgaben

• Design, plan and execute development and validation studies for protein-based biomarker assays, e.g., ELISA and immunoassays
• Build robust, scalable and transferable assay workflows, and support assay transfer and new technologies
• Write validation documentation per GLP/GCLP standards
• Develop and validate assays to diagnostic quality, incl. in-house IVD per IVDR
• Support clinical studies from qualification to analysis and reporting
• Handle patient samples and data in compliance with GDPR and internal policies
• Analyze data with Excel, GraphPad Prism and R or Python, applying statistics to guide decisions
• Use AI tools (LLMs) responsibly for analysis, literature research and documentation
• Work cross-functionally with R&D, QA and external partners
• Contribute to SOPs, reports, manuscripts and publications
• Present results internally, to partners and at scientific conferences

Kenntnisse

Protein biochemistry

Immunoassays

GLP/GCLP

Data analysis

Excel

GraphPad Prism

R

Python

English fluency

German (A2+)

Ausbildung

PhD in Biochemistry or Molecular Biology

Tools

Structured datasets/databases

Jobbeschreibung

Your Responsibilities

Assay development and validation

• Design, plan and execute development and validation studies for protein-based biomarker assays, e.g., ELISA and other immunoassays, proximity extension assays (PEA) and functional assays
• Build robust, scalable and transferable assay workflows, and support assay transfer and the implementation of new technologies
• Write high-quality validation documentation in line with internal and regulatory standards (GLP/GCLP)

Diagnostic quality and compliance

• Develop and validate assays to quality standards suitable for diagnostic use, including potential in-house IVD assays in line with applicable EU regulations (e.g., IVDR)
• Support clinical studies, from assay qualification to sample analysis and reporting
• Handle patient samples and data responsibly and in compliance with EU data protection law (GDPR) and internal policies

Data analysis

• Analyze and interpret experimental data with Excel, GraphPad Prism and R or Python, applying sound statistics to reach clear biological conclusions that guide project decisions
• Use AI tools, including large language models (LLMs), responsibly for data analysis, literature research and documentation, in line with data protection and quality requirements
• Where relevant, work with structured datasets and databases

Communication and collaboration

• Work cross-functionally with R&D, Quality Assurance and external partners
• Contribute to SOPs, reports, manuscripts and publications
• Present your results internally, to partners and at scientific conferences

Your profile

Required

• PhD in Biochemistry, Molecular Biology or a related field
• Strong background in protein-focused biochemistry
• Hands-on laboratory experience in developing and validating protein assays, e.g., immunoassays
• Familiarity with working in GLP/GCLP environments
• Confident data analysis with Excel and GraphPad Prism, and working experience with R and/or Python
• Fluent English, written and spoken
• German at A2 level or higher, and willingness to improve towards B1

A plus

• Postdoctoral or industry experience
• Experience with proximity extension assays and their readouts, qPCR and/or next-generation sequencing (NGS)
• Knowledge of diagnostic regulations (e.g., IVDR) and data protection requirements (GDPR)
• Experience with cellular models, ideally in a neurological context
• Experience with, or strong interest in, the responsible use of LLMs and other AI tools in scientific work
• Exposure to SQL or database environments

How you work

• You plan, run and document your own studies in a structured and reliable way
• You communicate results clearly, in writing and in presentations
• You bring your own ideas, question existing approaches and want to help shape how the team works

Why us?

• Translational research with direct relevance for patients with rare and neurodegenerative diseases
• An international, multidisciplinary team and close collaboration with pharmaceutical partners
• Room to take ownership of your projects, help build the team and keep learning
• Support with German language courses
• A 12-month contract with the possibility of transitioning to a permanent position