ID EXISTS
POS 3347
Status 5
DJM 1

Manufacturing Specialist

Beschreibung: For one of our German Biotech clients we are seeking freelance support as: Manufacturing Specialist (M/F/D)
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Tasks:
  • Support the tech transfer and scale up of the manufacturing process including Up-Stream-Process, Down-Stream-Process as well as final formulation and fill
  • Management of the tech transfer and scale up operations at the CMOs
  • Support the national and international projects under consideration of local laws, international guidelines (ICH) and applicable SOPs.
  • Planning and implementing scale-up from 200L to 2000L for USP, DSP as well as final formulation and fill
  • Support and manage the planning of Process Characterization and Process Validation activities
  • Writing / review of GMP documentations & reports
  • Review the process performance, product quality and the quality management system
  • Assist with regulatory submission preparations
  • Provide requested input to Product Development Plans and Portfolio Review
  • Represent the Company at external conferences and meetings
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Qualification:
  • Post graduate degree in natural / life sciences / engineering background
  • 5+ years of experience in an industrial GMP manufacturing / clean room environment preferably with biologics
  • Experience of tech transfer of processes and scale-up to commercial scale
  • Understanding of QC techniques applicable for biologics
  • Background in Process Characterization and Process Validation to support BLA / MAA
  • Experience of writing and or review of GxP documents (including SOP’s, qualification / validation plans / reports, batch records)
  • In depth working knowledge of EU GMP
  • Experience of equipment and method qualification / validation
  • Background in CHO cell manufacturing
  • Experience in viral safety evaluation & scale-down models
  • Must Have: Business fluency in English
  • Nice to have: German
  • Requirements:
  • Start: January / February
  • Duration: 6 months+
  • Capacity: ideally 5 days / week, at least 3 days / week
Bemerkungen: WANTED: Manufacturing Specialist (M/F/D). Please contact +49 89 18 90 998 17 or alexander.sepp@k-recruiting.com Skills: Biotech, Engineer (Biomedical Engineer), English, Technology & Product Transfer, Upstream & Downstream Processing
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Interesse geweckt?
Auf geht's!
Beginn: January
Laufzeit: 6 months+
Einsatzort: Berlin
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