Associate Director USP/DSP - Expert Process Transfer and Validation Drug Substance (gn)

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At MorphoSys, our ambition is to redefine how cancer is treated. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to give more life for people with cancer.
Our success is created by our people and we bring together exceptional talent from around the world. We are an equal opportunity employer and take pride in offering our colleagues an open, flexible, and diverse work environment. We are looking for people who share our values and are motivated to improve the lives of people impacted by cancer.
Our headquarters are in Planegg, Germany and our U.S. operations are anchored in Boston, Massachusetts. To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.

Your Responsibilities:

  • Support the Head of Production in all aspects of Drug Substance process transfer, scale up and GMP manufacturing activities including selection of CMOs, Risk Assessments, Scale Down Models and validation activities
  • Preparation and review of Drug Substance process development plans and reports as well as technical transfer documents for Drug Substance manufacturing
  • Review of Master Batch Records and executed batch records
  • Compilation and review of changes and deviations
  • Monitoring of Drug Substance process transfer and validation activities at external CMO
  • Supporting Vendor (CMO) selection
  • Review of submission documents
  • Oversight on process monitoring and evaluation of process data
  • Continuous process improvement in close collaboration with CMOs

Job Qualifications:

  • Degree in Biotechnology, Biology, Pharmacy or related discipline combined with 5+ years of relevant industry experience in development and manufacture of biotechnological products
  • Excellent knowledge of Upstream and/or Downstream Drug Substance manufacturing processes (preferably both)
  • Proven experience in process transfers between manufacturing sites / CMOs and all associated activities including raw materials, facility and equipment
  • Experience of regulatory guidelines and GMP requirements for early and late stage CMC development and production
  • Excellent command of English and preferable also 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
  • Simplified application for people from Ukraine (fast track via LinkedIn Profile); additional relocation package

Thank you for your interest! We are looking forward to receiving your pertinent application documents. For your application please use exclusively our career portal. 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