Senior Scientist Biological Analytics & Microbiology (m/w/d)
Core
Develop, assess, and implement analytical and microbiological testing strategies to ensure product quality, safety, and CMC decision-making in pharmaceutical drug development.
Role type
Senior Scientist, Biological Analytics & Microbiology
Builds
High-quality analytical and microbiological results for pharmaceutical products
Domain
Pharmaceutical industry, Biological drug development, Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biological drug development, Quality control, Microbiological product safety, Regulatory documentation, Analytical methods (HPLC-SEC, HPLC-CEX, CGE, CZE, icIEF, potency assays), Microbiological testing methods (sterility testing, bioburden determination, endotoxin testing), GMP compliance, AI-based tools for testing optimization
Preferred skills
Experience in pharmaceutical industry, German language skills
Technologies
HPLC-SEC, HPLC-CEX, CGE, CZE, icIEF, AI-based tools
Responsibilities
Develop and implement analytical and microbiological testing strategies, Provide expert input to CMC subteams, Evaluate and validate innovative microbiological methods, Lead or contribute to technology and continuous improvement projects, Assess scientific results and prepare regulatory documentation
Seniority
Senior, hands-on IC