Engineer – Synthetic Drug Substance Engineering (m/f)

REFERENZNUMMER:

321878/11

IHRE AUFGABEN:

-Technical oversight for API production for small molecule products manufactured in the client’s contract manufacturing network
-Detailed analysis and interpretation of production data and information as part of continued process verification, including actions to ensure process performance
-Root cause investigations for non-conformance and out of spec. incidents including process impact and corrective action
-Evaluation of the impact of changes to process inputs, equipment or procedures on process performance and API quality attributes
-Design, development and implementation of process improvements to enhance quality or improve efficiency of processes
-Design of experimental plans at laboratory and/or pilot scale to support issue resolution and improvements
-Technology transfer to manufacturing sites including process performance qualification
-On-the-floor technical support, when required, for successful implementation and execution of process technology or complex investigations
-Technical support for regulatory inspections
-Preparation of technical documents and presentations to cross-functional teams and management

IHRE QUALIFIKATIONEN:

-Master Degree in Chemical Engineering or Chemistry
-Experience with technical operations to support commercial API production
-Experience in introducing, implementing and/or executing chemical API processes in commercial or pilot plants
-Knowledge of API processing equipment, trains and best practices
-Experience in working with contract manufacturing organizations
-Experience related to process development, process characterization, technology transfer, scale-up and/or manufacturing of chemical drug substance (API) processes in a cGMP environment
-Understanding of regulatory and cGMP requirements and trends
-Familiar with analytical chemistry techniques and their application in Quality Control
-Understanding of API solid state characterization and bulk properties as they relate to drug product performance
-Excellent written and verbal communication in English

WEITERE QUALIFIKATIONEN:

R&D scientist