POS 3347
Status 5

Manufacturing Specialist

Beschreibung: For one of our German Biotech clients we are seeking freelance support as: Manufacturing Specialist (M/F/D)
K-RECRUITING Life Sciences Personalberatung - flip image
  • 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
K-RECRUITING Life Sciences Personalberatung - box background image
  • 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 Skills: Biotech, Engineer (Biomedical Engineer), English, Technology & Product Transfer, Upstream & Downstream Processing
K-RECRUITING Life Sciences Personalberatung - parallax image
Interesse geweckt?
Auf geht's!
Beginn: January
Laufzeit: 6 months+
Einsatzort: Berlin
WhatsApp-Service: Mit WhatsApp zum nächsten Projekt!

Bei uns sind Sie richtig. Nicht nur dank perfekt passender Projekte.


Was Sie als Consultant von uns erwarten können.


Weshalb sich eine Zusammenarbeit mit uns für Sie lohnt.


Jetzt registrieren und zukünftig passende Projekte direkt über WhatsApp erhalten.

Stellen Detail