Christian W. Maasch

Bridging local and global RA-CMC, PQ, compliance, and supply chain operations for more than 60 products in various markets through tech transfers, changes, launches, and improvements. Product Quality Regulatory Compliance, dossier authoring and CMC submission management. Tech transfer and process/product quality control for established and new products, as well as for clinical trial material (CTM). QMS, DMS and SOP management, LIMS, quality agreements, supplier qualification, PQRs, and LMS/GxP training.

Managing and leading a multidisciplinary team of consultants and scientists. Pharmaceutical product development, compliance, regulatory affairs, and lifecycle management of complex biologics, biosimilars and medical devices to support and improve R&D, manufacturing/CMC and QA/compliance, non-clinical and clinical development, and regulatory strategies and procedures. Strong Operational Business Acumen and Strategic, Budgeting and Capacity Planning. Operational and business transformation and change.

Department manager of analytical science supporting drug discovery/development of biologics and chemical entities by regulatory compliant analytical methods. Lead identification/characterization, manufacturing process development and QC, bioanalytics and biomarker discovery. Part of translational medicine team planning/conducting non-clinical studies, regulatory procedures/plans, and their translation to clinical development programs in inflammation, (immuno) oncology, immunology and metabolic disorders.

Leading and managing multidisciplinary in-house drug development projects targeting indications, like cancer, immunology, and inflammation. Co-development of a device for companion diagnostics and patient stratification. Member of a business and strategic development team. Working with complex project scenarios and the adaptation/ changes of processes and projects in order to meet the expectations of business partners, management and stakeholders.

Project Manager of milestone-based international cooperation with global players for the discovery and co-development of compounds in the field of oncology, inflammation, pain and metabolic disorders. Leading international multidisciplinary project teams and monitoring the project progress, timelines and budget.

Senior Scientist and mentor of the identification process of therapeutic nucleic acid-based scaffolds. Interim head of CMC. Biophysical analysis of drug/target interactions, DMPK and PD analysis. Identification and evaluation of target-related in-vitro and in-vivo pharmacology animal models.

Training of medical professionals on the regulation of calcium homeostasis and use of dihydropyridine therapeutics.

Setup and leading a lab on protein kinase research and renal disease.