Senior Scientist Bioanalytics and Microbiology (m/w/d)
Core
Develop, assess, and implement analytical and microbiological testing strategies to ensure product quality, safety, and informed CMC decision-making in biological drug development.
Role type
Senior Scientist Bioanalytics and Microbiology (hands-on IC)
Builds
High-quality analytical and microbiological results for pharmaceutical product development
Domain
Life Sciences / Pharmaceutical Industry / GMP-regulated environments
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biological drug development expertise, quality control, microbiological product safety, regulatory documentation, analytical methods (HPLC-SEC, HPLC-CEX, CGE, CZE, icIEF, potency assays), microbiological testing (sterility, bioburden, endotoxin), GMP compliance, AI-based tool optimization
Preferred skills
Pharmaceutical industry experience, German language skills
Technologies
HPLC-SEC, HPLC-CEX, CGE, CZE, icIEF, AI-based tools
Responsibilities
Develop and implement testing strategies, contribute to scientific direction and CMC subteams, evaluate and validate innovative microbiological methods, lead continuous improvement projects, prepare reports and regulatory documentation
Seniority
Senior, hands-on IC