Engineer – Synthetic Drug Substance Engineering (m/f)

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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
Start
ab sofort
Dauer
12 MM
Von
Hays AG
Eingestellt
08.11.2016
Ansprechpartner:
Kerstin Werner
Projekt-ID:
1234397
Vertragsart
Freiberuflich
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