Wir haben zum nächstmöglichen Zeitpunkt folgende Position zu besetzen:

Manager CMC Regulatory Affairs (gn)

 

As a member of the CMC team, your main focus will be care of CMC RA‑related activities in the field of MorphoSys proprietary product development, working in close cooperation with interdisciplinary project teams and the entire CMC functions.

Your Responsibilities:

  • Management of operational RA aspects within the daily collaboration with CMOs and partners during CMC development in close coordination with the RA department and interdisciplinary project teams
  • Coordination of document compilation for late stage development activities like CQA assessment, process characterization/process validation, and control strategy establishment
  • Preparation of quality sections for BLA and MAA
  • Observation and tracking of CMC relevant regulatory interactions between MorphoSys, external partners, and regulatory agencies
  • Contribution to internal and external meetings as CMC-RA expert for GMP-relevant guidance and regulations
  • Continued observance of regulatory guidance and regulations with respect to revisions or additions

Your Requirements:

  • Degree in Life Sciences, Pharmacy, Chemical Engineering or Bioengineering
  • Proven track record in biotech or pharmaceutical industry
  • At least 4 years professional working experience in the GMP/RA environment, preferably in the development of biologics
  • Experience in state-of-the-art Regulatory Affairs related procedures in drug development for biologics
  • Preferably experience with CMC requirements for late stage clinical development and compilation of module 3 submission packages
  • Highly motivated and open-minded team player with well-developed interpersonal abilities and a clear commitment to represent CMC-RA in interdisciplinary working groups
  • Excellent communication skills, both in English and German
  • Sound knowledge of Microsoft Office applications

Wir bieten Ihnen:

  • Kreatives Arbeiten in X-functional Teams
  • Offene und wertschätzende Unternehmenskultur
  • Multikulturelles Umfeld
  • Arbeiten in einem attraktiven, hochwertig ausgestatteten Gebäude mit Betriebsrestaurant
  • Kostenfreie Sportangebote und Sprachkurse
Über Ihr Interesse und auf Ihre aussage­kräftigen Unter­lagen freuen wir uns! Bitte be­wer­ben Sie sich direkt über unser Karriere­portal www.morphosys.de/karriere. Wir bieten Ihnen nicht nur aus­ge­zeichnete Ent­wicklungs­möglich­keiten, sondern unter­stützen Sie von Anfang an – auch bei Ihrem Umzug.
MorphoSys AG, Semmelweisstraße 7, 82152 Planegg