Dr. Enno Schweinberger

In my current role as Head Global Quality Management Drug Substance at Siegfried, I support Quality Management and compliance across seven international API manufacturing sites in Europe, the USA and China. The role combines global Quality governance with practical experience in pharmaceutical operations, manufacturing networks, regulatory inspections and complex Quality systems.

In this role, I led the site Quality Assurance organization and held senior Quality and FvP responsibilities across pharmaceutical manufacturing, Quality Management Systems and GMP compliance. The position combined operational QA leadership with regulatory responsibility, inspection readiness and Quality oversight of internal and external manufacturing activities.

- Leadership of the Finished Drug Products Quality Assurance department with 4 employees - Responsibility for the Quality Management System for finished medicinal products at the Zofingen site - Release responsibility for IMPs and commercial finished medicinal products - FvP / Responsible Person for finished medicinal products (solid oral dosage forms) - Management of changes, deviations and customer complaints - Development and approval of Quality Agreements

- Leadership of an Analytical Development department with approximately 15 employees - Responsibility for GMP-compliant analytical development processes - Responsibility for release analytics of clinical trial material and commercial finished medicinal products - Contribution to registration-relevant documentation and responses to health authority requests - Leadership of analytical development activities supporting pharmaceutical manufacturing and product release

- Establishment and leadership of a working group with 3 employees - Development and validation of chromatographic and spectroscopic analytical methods - Analytical development for solid oral pharmaceutical dosage forms - Planning and execution of stability studies according to ICH requirements - Project-based coordination of pharmaceutical analytical development activities

- Development of a single-molecule DNA sequencing technique - Research collaboration with Heinrich-Heine-Universität Düsseldorf - Applied advanced fluorescence-based analytical techniques in a biotechnology research environment - International scientific research experience in the United States

Activities and societies: Topic: "Multidimensionale Single-Molecule Fluorescence-Spectroscopy on fluorescently labeled biomolecules" Studies performed at the Max-Planck-Institute for biophysical chemistry

Basenmodifizierte Nukleoside und deren Einbau in DNA

Fermentationstechnologie / Mikrobiologie