Ing. Bernhard Brodowicz

GMP | Pharmaceuticals | Medical Devices | CSV | Qualification | Validation | Audits

• Leaded the metrology team (2 Metrology Experts and 3 Lab Associates) including task delegation, defining priorities, staff development & training • Capacity planning and effectively ensuring the throughput of tasks within the metrology team • Providing metrology support to development project teams • Ensured timely implementation of new equipment • Managed the equipment lifecycle including calibrations, maintenance and changes • Ensured that process and timeline requirements for procurement are met

• Reviewed and approved analytical instrument qualifications, risk assessments and SOPs • Acted as eCompliance Manager for SDC Unterach • Tracked re-qualification and calibration tasks • Released reference standards • Reviewed logbooks and protocol books • Approved deviations, change controls and CAPAs related to analytical development • Conducted self-inspections and supported inspections by authorities

• Reviewed and approved method validations, stability protocols, instrument qualifications • Acted as eCompliance Manager for IT, Production and QC Laboratory • Reviewed and approved process and cleaning validations, risk assessments, APQRs, equipment qualifications, change requests, CAPAs and SOPs • Supported GxP-activities on PFS production-line to ensure department and production goals are met and performed QA-oversight activities on the shop floor to ensure audit readiness

• Planned and managed equipment qualification, method validation and transfer projects • Reviewed and approved method developments , experimental designs and investigations as well as risk analysis, qualifications and validations • Performed internal and external audits and actively contributed to inspections by authorities

• Cultivated and stimulated human tumor cell lines • Extracted, separated and stimulated human leukocytes • Diagnosed GPCR expression and responses via qRT‐PCR, Western blot analysis, flow cytometric analysis (FACS), ELISA, proliferation and cytotoxicity assays and Label‐free diagnosis • Supervised interns and master students Achievements: Discovered galanin receptor expression on human immune and tumor cells and detected cell responses to galanin receptor agonists and antagonists

• Cultivated human tumor cell lines • Analysed GPCR expression via qRT‐PCR • Histologically detected receptors on cells and tissues Achievements • Demonstrated subtype specificity for human anti‐galanin receptor antibodies for the first time • Illustrated for the first time and in detail the cellular expression and localization of the galanin

• Performed computer-aided differentiation of toxic cyanobacteria • Conducted multilocus sequence typing of the cyanobacterium Planktothrix spp. • Quantified the net production of the toxic microcystine via HPLC and mass spectrometry

• Instructed recruits and trained peacekeepers for foreign operations • Managed the office of the company and maintained the complete IT-infrastructure on base

Graduated with distinction Thesis: ‘Evaluation of galanin receptor antibodies in normal and pathologic tissues’

Thesis': ‘Ribosomal associated diseases’ and ‘Recombineering in DNA cloning’

Thesis: ‘Embedded-LAN/Time Recording Device’