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For more information speak to Danielle Boniface on 01707 817313

To apply by email danielle.boniface.12876.10471@justpharma.aplitrak.com

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Expert, Biopharmaceutical Process ValidationRef: BBBH4420

Salary:Up to £0.00 per annum

Added:25 Oct 2018

Region: Germany

Category: Clinical Development

Just Pharma are seeking an Expert in Validation of Biopharmaceutical Drug Substance and Drug Product Manufacturing processes. The newly generated position will be part of the Protein Sciences & CMC Department and will closely interact with QA and RA department as well as external partners.


YOUR RESPONSIBILITIES:

  • In close collaboration with our CMO you will be responsible for validation of antibody Drug Substance and Drug Product manufacturing processes including:
    • Process characterization studies
    • Compilation of validation master plan
    • Process performance qualification runs
    • Compilation of control strategy
  • Oversight and responsibility for development work packages:
    • Leachables and extractables evaluation
    • Elemental impurities evaluation
  • Contribute to quality sections of regulatory submission documents
  • Represent your area of responsibility across functions and departments as well as at CMOs
  • Provide strategic input to process development and GMP manufacturing of the compnays development programs


YOUR REQUIREMENTS:

  • Degree in Biotechnology, Biology or Pharmacy, combined with several years of relevant industry experience
  • Proven track record in validation of antibody manufacturing processes
  • Deep understanding of scale down models, process characterization studies and all aspects of process validation
  • Sound knowledge of the regulatory guidelines and GMP requirements for late stage development and filing
  • Proven experience in pharmaceutical production and analytical testing of biotechnological products
  • Team player with highly structured approach and well developed communication skills
  • Excellent command of English and German both written and spoken
  • Initiative, confidence and flexibility


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 touch with Danielle on +441707817313 or email

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