Christian W. Maasch
Angestellt, Head of PQ, RA-CMC Compliance and Change Control Mgmt; Deputy Quality Systems, Takeda GmbH Betriebsstätte Oranienburg
Berlin, Deutschland
Werdegang
Berufserfahrung von Christian W. Maasch
Bis heute 4 Jahre und 11 Monate, seit Juli 2019
Head of PQ, RA-CMC Compliance and Change Control Mgmt; Deputy Quality Systems
Takeda GmbH Betriebsstätte Oranienburg
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.
2 Jahre und 8 Monate, Nov. 2016 - Juni 2019
Principal Consultant R&D/RA-CMC and Compliance & Executive Management TEAM GER
ProPharma GroupManaging 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.
6 Jahre und 11 Monate, Dez. 2009 - Okt. 2016
Director QC / Product Quality Biotech in R&D and CMC
NOXXON Pharma AGDepartment 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.
14 Jahre und 10 Monate, Jan. 2002 - Okt. 2016
Senior Project Manager – Research and Development
NOXXON Pharma AGLeading 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.
2 Jahre und 8 Monate, Dez. 2007 - Juli 2010
Senior Project Manager – Research & Development Alliances
NOXXON Pharma AGProject 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.
7 Jahre und 11 Monate, Jan. 2002 - Nov. 2009
Senior Scientist - Lead Discovery/ Preclinical R&D/ CMC/ Biophysics
NOXXON Pharma AGSenior 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.
10 Monate, Jan. 1999 - Okt. 1999
Lab Head/ Senior Scientist
Mount Desert Island Biological Labs, Maine, USA
Setup and leading a lab on protein kinase research and renal disease.
2 Jahre und 10 Monate, Nov. 1996 - Aug. 1999
Scientist
Max-Delbrueck Centre for Molecular Medicine
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Französisch
Grundlagen