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(Senior) Bioanalytical Principal Investigator LBS / GLP Study Director(m/w/x)
Leading GLP-compliant bioanalytical studies and method validations for drug development. Hands-on ligand-binding and cell-based assay experience required. Modern labs, continuous professional development.
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Anforderungen
- Degree in Biochemistry, Biology, Chemistry, or related scientific discipline
- PhD advantageous
- Hands-on experience with ligand-binding assays
- Hands-on experience with cell-based assays
- Experience in regulated environment (GLP, GCP, GMP, ISO)
- Strong analytical thinking
- Strong problem-solving skills
- Excellent written communication skills in English
- Excellent verbal communication skills in English
- Ability to manage multiple projects
- High quality and attention to detail
- Previous experience as Study Director
- Previous experience as Principal Investigator
- Previous experience in equivalent scientific leadership role
- Knowledge of biomarker bioanalysis
- Knowledge of pharmacokinetic (PK) bioanalysis
- Knowledge of immunogenicity (ADA) bioanalysis
- Knowledge of biologics bioanalysis
- Good German language skills
- Experience with pharmaceutical clients
- Experience with biotechnology clients
Aufgaben
- Lead GLP/GxP-compliant bioanalytical studies and method validations
- Serve as Study Director and Principal Investigator
- Develop and approve study plans, validation protocols, and reports
- Review and approve analytical data for scientific integrity and compliance
- Ensure study activities comply with SOPs, regulations, and client expectations
- Act as primary scientific and operational client contact
- Provide regular project updates and maintain strong communication
- Support client meetings, scientific discussions, and audits
- Coordinate laboratory activities for efficient study execution
- Train and mentor assigned laboratory personnel
- Contribute to process improvements and quality standards
- Support bioanalytical data management and documentation
- Lead complex or strategic client programs
- Mentor junior Principal Investigators and laboratory staff
- Serve as subject matter expert for ligand-binding and cell-based assays
- Contribute to business development, client presentations, and scientific initiatives
Berufserfahrung
Ausbildung
Sprachen
Tools & Technologien
Benefits
- Flexible working hours
- Structured onboarding
- Continuous professional development
- Modern laboratories
- State-of-the-art infrastructure
- Attractive employment conditions
- Career growth opportunities
- Globally recognized CRO
Von Nejo automatisch aufbereitet
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The company is a leader in early clinical research, combining medical expertise with cutting-edge technology to deliver exceptional results.
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