Process Engineer – Expert in Drug Substance Process Transfer (gn)

 MorphoSys AG  Planegg Raum München
MorphoSys’ mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich!

We would like to fill the following vacancy as soon as possible:

Process Engineer – Expert Process Transfer Drug Substance (gn)

Your Responsibilities:

  • Support the Head of Production in all aspects of Drug Substance process transfer, process development and GMP manufacturing activities
  • Preparation and review of Drug Substance process development plans and reports as well as technical transfer documents including risk assessments
  • Review of Master Batch Records and executed Batch Records
  • Compilation and review of changes and deviations
  • On site monitoring of Drug Substance process development and process transfer activities
  • Oversight on process monitoring and evaluation of process data
  • Support compilation and review of regulatory submission documents
  • Point of contact for Technical Transfer Activities

Requirements:

  • Degree in Biotechnology, Biology, Pharmacy or related discipline combined with several years of relevant industry experience in development and manufacture of biotechnological products
  • Excellent knowledge of Drug Substance manufacturing processes for Biologicals (upstream and downstream)
  • Proven experience in process transfers between manufacturing sites / CMOs and all associated aspects including raw materials, facilities and equipment
  • Solid knowledge of regulatory guidelines and GMP requirements for early and late stage CMC development and production of Biologicals
  • Experience in compiling regulatory dossiers for project transfer activities
  • 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

Thank you for your interest! We are looking forward to receiving your pertinent application docu­ments. For your application please use exclusively our career portal www.morphosys.com/careers/job-opportunities. We offer not only excellent career prospects, but also support you from the very beginning – even helping you move if necessary.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg

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Über MorphoSys AG

MorphoSys’s mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of...
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