Dr. Bernd Hoffmann

-fulfilling duties as Kontrolllaborleiter §9AMBO -US market access, FDA Pre-Approval Inspect. -Writing of regulatory documents: PMA and IDE dossiers for FDA; CTD for DP approval in the EU -Communication with AGES, FDA (responding to Deficiency and D90 Letters) -Prep. of regulatory changes (Variations) -Complex, cross-site coord. of product launch and QC lifecycle management of Letybo DP (Botul. Neurotoxin) -assay transfers including ELISA and crll-culture potency assays -Auditing contr. manuf. and ext. labs

Leadership of the QC department with 25-35 employees and 4 subdepartments: QC Lab, Microbiology, Incoming Goods Control & Final Packaging Control, Qualification & Validation // team development and talent acquisition (employees and consultants) to ensure the right expertise for achieving the company’s goal of US market access // Responsibility for cost center, budget and personnel planning // Implementation of the new EU Regulation 2017/745 on Medical Devices (MDR)

-Managerial responsibility for QC department with >40 staff members -Team development -Cost center responsibility, departmental long-term investment planning -Client and authority inspections -Intra- and interdepartmental operational excellence initiatives -Resource allocation, planning, prioritization to ensure on-time delivery -Continuous improvement of cGMP compliance and data integrity -Compliance with all laws and guidelines relevant for the pharmaceutical industry

- Build-up and supervision of physico-chemical and immunological QC laboratories - Implementation of GMP quality systems within QC department - GMP compliance and FDA inspection readiness - Audit preparation and attendance (AGES, FDA) - Validation and transfer of analytical methods - Release and stability analytics - OOS investigations - Cost center responsibility and departmental budget planning - Training of personnel

- Supervision of analytical laboratory - Development, validation and transfer of analytical methods to QC - GMP compliance and FDA inspection readiness - Stability analytics and service analytics for chemical synthesis labs

- Build-up of NMR laboratory - NMR-spectroscopic protein structure determination - NMR-based high-throughput screening of protein/ligand interactions - Structure-based drug design - Software programming

- Development of novel methods for automized protein structure determination - Software programming

- NMR-spectroscopic investigation of structure/function relationships in ribozymes - in-vitro RNA synthesis and purification

Analytische Chemie, Strukturbiologie, NMR-Spektroskopie, Proteine, RNA