A Bethesda / Munich based and NASDAQ traded Drug Discovery company develops antibody based therapeutics for the treatment of cancer, autoimmune- and inflammatory diseases. With its more than 120 professionals in both sites it combines excellent science with a highly, integrated development organization. It complements inhouse competence by a network of academic and industrial partners.
Life Science professionals in all of Central Europe wish to work for this company which is located in one of the most popular areas in Europe: 45 minutes by car to Garmisch, various lakes and castles in bycycling distance. Oktoberfest almost in walking distance.
Tasks:
The Munich based individual covers all documentation within the Department Process Sciences including...
the preparation, management, and archiving of documentation within Process Sciences.
the preparation, review, and maintenance of CMC-related regulatory documents (M4Q module, for e.g. INDs/CTAs/MAAs/BLAs, etc.) including co-ordination of the documents provided by GMP Contract Manufacturing Organisations.
the review, management, and archiving of GMP manufacturing documentation
the preparation of briefing documents for regulatory interactions.
Profile:
a Degree in Pharmacy, Biotechnology, Biology, Chemistry or related field.
at least 3-5 years of industry experience in the area of CMC documentation for Biologics.
Experience and knowledge of the quality module (M4Q section) for IMPDs/INDs/CTAs for Biologics.
familiarity with regulatory requirements with regard to documentation and have a good working knowledge of the current guidelines (ICH/EMA/FDA; EP/USP/NF).
a native English speaker; knowledge of German is advantageous but not essential.
Excellent solid skills in Microsoft Office programs.
Most important is a strong motivation and interest to work together with our team on applied and development-specific questions of process sciences.
