Senior Scientist - Clinical Chemistry Reagent Development (IVD) | Senior Scientist (m/w/d) - Entwicklung klinisch-chemischer Reagenzien (IVD), Zweigniederlassung M...
HUMAN Biochemica und Diagnostica mbH
Job Summary
As a Senior Scientist, you will play a pivotal role in the development and optimization of clinical chemistry reagents throughout the entire product lifecycle, from initial formulation to stable serial production. Your day-to-day responsibilities will include conducting robustness, stability, and performance evaluations on analytical systems, troubleshooting production-related issues, and implementing corrective and preventive actions (CAPA). You will also be responsible for refining existing recipes and specifications while ensuring seamless technology transfer to production environments. A key aspect of this role is maintaining rigorous documentation in compliance with international quality standards like ISO 13485. This position is ideal for a detail-oriented professional who thrives in a regulated IVD environment and enjoys taking ownership of technical projects. You will work in a collaborative, medium-sized company that values decision-making and provides a supportive environment for professional growth, offering unique benefits such as a lifetime working time model, private health insurance, and flexible working arrangements.
Required Skills
Education
University degree in Chemistry, Chemical Engineering, Biochemistry, or a comparable field.
Experience
- Several years of relevant professional experience in liquid reagent development
- Professional experience in clinical chemistry within an IVD environment
- Proven experience in formulation and recipe development, including buffer and additive systems
- Experience in technology transfer and scaling laboratory recipes to production
- Experience in systematic root cause analysis and implementing CAPA measures
Languages
Additional
- Must be eligible to work in Germany. Proficiency in regulatory requirements for IVD products (ISO 13485) is required.