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For more information speak to Danielle Boniface on 01707 817313

To apply by email danielle.boniface.22462.10471@justpharma.aplitrak.com

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Process Engineer 2 Yr FTC Munich Ref: BBBH4421

Salary:Up to £0.00 per annum

Added:25 Oct 2018

Region: Germany

Category: Regulatory Affairs

Just Pharma are currently recruiting on behalf of a German biotechnology company who are searching for an Expert in Biopharmaceutical Process Validation within Munich. This fantastic opportunity is a brand new position which is purely down to expansion with the company being one of the premier biotechnology companies in Germany. You will be part of the Protein Sciences and CMC Department and you will be closely interacting with the QA and RA department as well as outside partners.

Support Head of Production in all aspects of Drug Substance and and Drug Product process development and GMP manufacturing activities:


YOUR RESPONSIBILITIES:

  • Preparation and review of process development plans and reports as well as technical transfer documents
  • Review of Master Batch Records and executed batch records
  • Compilation and review of changes and deviations
  • Monitoring of development and transfer activities at CMO
  • Review of submission documents
  • Oversight on process monitoring and evaluation of process data
  • Point of contact for CMOs and External Collaboration Partners


YOUR REQUIREMENTS:

  • Degree in Biotechnology, Biology or Pharmacy, combined with relevant industry experience
  • Experience of regulatory guidelines and GMP requirements for early stage CMC development and production
  • Understanding of pharmaceutical development and GMP production of biotechnological products
  • Experience in the scientific and statistical evaluation of process data
  • Excellent command of English and German both written and spoken
  • Team player with excellent communication and management skills
  • Well organized and able to handle multi-tasking situations under time constraints


WE OFFER:

  • Creative working in X-functional teams
  • Open and appreciative corporate culture
  • Multicultural environment
  • Working in an attractive, high-quality equipped building with restaurant
  • Free sports and language courses

Please get in contact with Danielle +441707817313 or email

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