Dr. Jörg Hagedorn

Heading the QC department and the team Responsible for : release , stability testing, specifications, OOS, change control etc. acc. to AMWHV Invest and budget planing Continous development of QC with focus on team competencies and new analytical methods Support Operations during process optimization

Heading the analytical department for enzyme analytics and acting as representative and driver of analytical development/ innovation in global product development. - development of project strategy; evaluation and coordination of projects - planning and control of budgets and resources - ensure GMP compliance - develop know- how and establish new technologies - as head of quality control responsible for release of clinical supplies, stability testing, specifications, OOS, change control etc.

Scientific lead and responsible for the analytical team as well for external labs with regard to execution of project strategy taking into account regulatory and quality (cGMP) requirements: - Method Development, validation and transfer of analytical methods - Stability studies - Release testing - characterization of API and drug product Analytical representative in several global product development teams and responsible for analytical strategy to support formulation development

Heading an analytical lab dealing with enzymatic activity assays, gel electrophoresis, dissolution/ disintegration testing, water determination (Karl- Fischer ) and other methods descibed in European and US Pharmacopoeia.

Heading a bioanalytical lab in the biopharmaceutical division and responsible for - development and validation of immunoassays (ELISA, Biacore) - release testing of biopharmaceuticals (monoclonal antibodie and others) - characterization of therapeutic proteins Analytical lead in multidiciplinary project teams - responsible for all quality aspects within process development - support regulatory group to provide submission documentation

Development and optimization of biosensor systems Customer service with respect to individual application solutions

Maintanance and optimization of analytical methods for the determination of tumor markes in urin samples by HPLC and GC-MS Data monitoring and evaluation Development of new HPLC based analytical methods for the determination of creatinin and sugars

Bioanalytics Technical Chemistry Biochemistry