Deputy Head of Production (gn)

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:

Deputy Head of Production (gn)

Your Responsibilities

  • Implementation and oversight of Drug Substance and Drug Product manufacturing processes including authorization of master batch records, batch record review and risk assessments
  • Handling of deviations, change control requests and complaints
  • Support process validation and compilation of regulatory submissions (IMPD / IND / BLA)
  • Support implementation and maintenance of SOPs
  • Supervision of process development and GMP manufacturing activities at external Contract Manufacturers and MorphoSys internal process development
  • Selection of CMOs for Cell Line Generation, Drug Substance and Drug Product Manufacturing activities
  • Provide scientific and strategic input for efficient preparation and execution of CMC development plans
  • Closely collaborate with internal and external project teams and ensure seamless supply of high quality material for clinical studies
  • Represent your area of responsibility across functions and departments, at CMOs and collaboration partners
  • Report to the Head of Production / Head of CMC

Your Requirements

  • University Degree in Biotechnology, Biology or Pharmacy, combined with several years of relevant industry experience
  • Proven track record in process development and GMP manufacturing of biologicals (preferably antibodies) for clinical trial supply (Phase I to pivotal phase)
  • Sound knowledge of the pharmaceutical laws (AMG, AMWHV), regulatory guidelines and GMP requirements
  • Deep understanding of 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

 

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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