Manufacturing Scientist
vor 2 Wochen
Our client, an international pharmaceutical company based in the area of Zug is searching for a Manufacturing Scientist to join their team.
- Start date: 01/03/2023
- Duration: 1 year
- Extension: possible
- Work location: Zug area
- Workload: 100%
Your mission:
- Support the commercial manufacturing process of designated products.
- Support the technical transfer of DP processes into CMOs from TD to CMO, and/or from CMO to CMO.
- Execute Process Validation Runs, (review, approval, and execution of process validation activities).
- Support commercial manufacturing activities at CMOs (continuous process verification, APRs manufacturing technical documentation).
- Leading drug product manufacturing investigations (oral dosage forms), root cause analysis and identification of process related CAPA's.
- Access and implement manufacturing processes changes to existing commercial processes including CAPAS and to perform document risk assessment.
- To design, execute and analyze technical studies and to support the Technical Product Lead.
- Review of process trends, to identify anomalies and implement corrective actions.
- Contribute to writing of regulatory documentation, filings, briefing books, RTQs.
Your background:
- Degree in pharmaceutical technology, engineering (chemical or pharmaceutical) or similar scientific background.
- Minimum 5 years of experience in the pharmaceutical industry, working in cross functional teams, and knowledge of GMPs. Ideally, in product development, commercial manufacturing, technology transfer or manufacturing of drug product (oral dosage, preferred) related to small molecules.
- Experience in writing technical regulatory documentation (CTD module 3), briefing books and answering authorities' requests.
- Fluency in English.
Our client offers an exciting position in a multi-disciplinary and collaborative environment.
Does this description sound like you? If so, please get in touch, and you could be embarking on a new and exciting professional opportunity.
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