Beschreibung
We are looking for a pharmaceutical client for a
Engineer – Synthetic Drug Substance Engineering (m/f)
Reference: -en
Start: asap
Duration: 12 MM
Place: in Zug
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- 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
Your qualifications
- 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
Skills:
- R&D scientist