Bruno Muller Email and Phone Number

* Designing, planning, execution, interpretation and reporting of DS and formulated DP by applying HPLC techniques with high focus on quality.

* Testing of Raw materials, intermediate and finished products.* HPLC/UPLC, UV-Vis Titration, IR-Spectroscopie, In-vitro dissolution, Karl-Fischer, Polarimetry, Viscosity, TOC. * Quality Competences: cGMP, USP, EP, JP* Cleaning Validation and Verification.* Data check. Review and writing of SOPs. * Software used: Empower, Winsotax, Tiamo.* Acquisition of equipment responsibilities: balances, UV Spectrophoto- meter, pH-Meter, TOC Analyser, Sterilisator.

• Physico-chemical and protein analyses for the manufacturing of a biopharmaceutical compound (monoclonal antibody).• All activities related to In-Process and Quality Control in cGMP environement: management, planning and analysis of samples, validation, methods transfer, release, stability testing.• HPLC expertise, good experience with Agilent, Waters and Dionnex equipments.• Methods used: CEX, SEC, HIC, RP with UV and Fluorescence X detectors, spectrophotometry, Peptide Mapping, IEF, Protein A Bindings capacity, Osmolality, pH-metry, conductimetry, Turbidimetry, knowledge of the SDS PAGE analysis.• Release of Drug Substance with the Q-DIS software.• Responsibilities for maintenance, qualification / calibration of analytical equipment (e.g. HPLC)• Chromeleon Power User: introduction of new sequence templates, creation of reports.• Support of the Lab Head for development, optimization and validation of analytical methods.• ESOP Author, writing of new SOP’s and FRM’s versions.• Responsible for international shipments with Nomex.

• Analytical control of raw materials, intermediates and final products.• Significant experience in HPLC, GC, Thin Layer Chromatography.• Titrations (Potentiometry, colorimetry, oxydoreduction).• Water Determination with the Karl Fischer method.• Determination of physicochemical constants: pH, density, melting point (Büchi), Particle size (Alpine).• Microbiological analysis.• Validation, development and improvement of analytical methods.• Management and archiving of the samples. Statistical work on the results obtained.

• Writing and translation (french / english) of the procedures for the manufactured products.• Study of solvents needs for each manufactured products.• Responsibilities for the management and archiving of the technical documentation.• Search of courses for the further training of employees.

• Pasting and dissolution of colorant agents.• Set up, Start up and Monitoring of a semi-automated drier.

• Synthesis, purification and analysis of new additives molecules.• Stability study on the synthesized molecules.• Bibliographic search on the syntheses to be realized.