Senior Scientist – Development of Clinical Chemical Reagents (IVD) (m/f/d)

HUMAN offers safe laboratory diagnostics in more than 160 countries. How do we do that? With reliable reagents and analysis systems as well as employees who live customer orientation and contribute to improving global health care. Enjoy a medium-sized company where you can fill free spaces with a sense of decision. At the next time we are looking for Senior Scientist (m/w/d) – Development of Clinical-chemical Reagents (IVD) Location Magdeburg In this key role, you develop and optimize clinical-chemical reagents along the entire product life cycle – from formulation to stable series production. You provide valuable interface work and enjoy co-design and take over responsibility. We offer a trusted working environment in which you can translate your expertise directly into market-relevant products.

Development and optimization of clinical-chemical reagents and assays incl. Robustness, stability and performance assessment on relevant analysis systems Analysis of production-related problems and deriving effective corrective and preventive measures Continuous improvement of existing recipes, specifications and production instructions as well as support for transfer to production Ensuring the documentation of the area of responsibility according to applicable quality and regulatory requirements (e.g. ISO 13485)

University degree in chemistry, chemical engineering, biochemistry or comparable Multiannual relevant professional experience in liquid reagent development Clinical Chemistry in the IVD environment e.g. with the focus on formulation and formulation development: buffer and additive systems (e.g. detergents, stabilizers, preservation), pH/ion strength, compatibility, stability concepts (real-time/accelerated) Troubleshooting & Production Support: Systematic Cause Analysis for Deviations (Raw Material Exchange, Process/Handling Influence, Advertising/NCs), Dissipation and Implementation of CAPA and Effectiveness Testing Tech Transfer / Scale-up: Transfer of laboratory formulations to production (manufacturing regulations, in-process controls, specifications, deviation management)

readiness to work in a regulated environment and knowledge of existing quality and regulatory requirements Very good knowledge of analytical chemistry and typical QC/characterization analysis (e.g. UV/Vis, photometric assays, pH/ conductivity, titration, viscosity, optionally HPLC) Safe handling of laboratory and documentation standards (SOP/SAA, raw data management, data integrity/traceability) and routine in the preparation of technical reports, specifications and decision bases High analytical and problem-solving competence as well as pragmatic and solution-oriented methods High level of self-initiative, quality awareness and communication strength (German and English) paired with hand-on mentality

Attractive employer subsidy for occupational pensions Employer-funded private health insurance HUMAN Lifetime Model Flexible working hours and home office by appointment JobRad (bicycle leasing) and IT leasing Canteen and free fruit and drinks Further training Free parking in the house