Karsten Marx

Background

About Karsten Marx

As a Chemistry, Manufacturing and Controls (CMC) Expert and detail-oriented person, I am passionate about the CMC interface between precise analytical/ scientific data (technical CMC) and laws/ regulations (regulatory CMC, Regulatory Affairs RA). One of my main responsibilities is the timely delivery of high-quality documents/ files (1) for submission to NCAs (QOS, IMPD, IND, CTD, NDA),(2) in preparation of meetings with CAs (SA, EoP2) and (3) in response to their queries. As the clock of regulatory authorities is always, my hands-on attitude is important as is keeping a clear overview under time pressure. Within the organization, I foster and enjoy close interactions (1) with ClinOps for the correct planning and timely delivery of clinical supply (CS, CTS),(2) with ADME/Tox for new qualification limits of impurities, definition of PDEs,(3) with Chemistry for lead optimization and formulation development, and (4) with QA for handling CMC-related aspects of the QMS. For external contacts like coordinating with CROs and selecting, qualifying, and managing CMOs, CDMOs and CS providers, my additional experience in BD, contract law and management, medicinal chemistry and process chemistry are additional assets