Aarau, Aargau, Switzerland
Versatile downstream processing engineer with more than 19 years of experience in early-phase biopharmaceutical process development, specializing in protein purification (DARPins, scFv, scDb, PEG-scFv, mAb), process optimization, scale-up, and technology transfer into GMP production. Additional expertise includes plant-based natural product isolation and formulation into drug delivery systems for medical device applications. Responsibilities in DSP and CMC Project Management DSP Process Development and Manufacturing - Conduct in-house downstream process (DSP) development activities, including technology transfers to GMP vendors. - Manufacture in-house material for DSP development and preclinical studies. - Contribute to the evaluation and selection of GMP vendors involved in DSP manufacturing. Technology Transfer and Production Support - Organize, coordinate, and communicate to support technology transfer to contract manufacturing organizations (CMOs). - Provide on-site support during pilot and large-scale production campaigns (person-in-plant). - Review and approve master batch records and related GMP documentation (e.g., deviations, change requests). Documentation and Reporting - Write development reports and other relevant documents (e.g., memos, risk assessments). - Maintain oversight of manufacturing documentation. - Support the IMPD/IND submission process. Drug Product Manufacturing and Supply Chain - Organize and coordinate drug product manufacturing activities performed by CMOs. - Manage external activities related to investigational medicinal product (IMP) labeling and packaging. - Coordinate material supply for GLP toxicology studies, comparability studies (Tox vs. GMP material), forced degradation studies, and Phase 1/2a clinical trials. - Support drug product manufacturing and stability studies; advise on timelines and required quantities for clinical administration. Clinical Trial Support - Organize and manage study drug supply information to support clinical trials. - Assist hospital pharmacies with IMP handling for clinical trial execution. - Contribute to CMC batch release for use in clinical trials. CMC Project Management - Act as CMC lead and manage assigned CMC projects. - Request and review quotes for GMP manufacturing and drug product filling activities. - Manage the CMC-specific project budget. - Coordinate GMP activities including master cell bank production, engineering runs, GMP drug substance and reference standard manufacturing, and release testing.
Development of isolation processes of phytochemicals from natural products and its formulation into phospholipid-based delivery systems such as micelles and liposomes. The main focus is on the production of stable colloidal dispersions by modulating lipid properties such as composition, size, and charge in order to improve vesicle entrapment efficiency and stability to ensure the maximum effectiveness of the active ingredients at the site of action.
Planning, conduction, interpretation and reporting of therapeutic protein purification processes (refolding optimization, protein chromatography- and tangential flow filtration development) in lab- and pilot-scale to generate API (up to 100 g) for preclinical activities (e.g. formulation development, stability studies, product characterization, dose range finding and Tox-studies). Protein formats: scFv, scDb, PEGylated scFv and mAb. Equipment and scale: - ÄKTA chromatography systems (explorer, avant 25/150, process) - Chromatography columns (up to ID: 45 cm, volume up to 20 L) - Refolding volumes up to 560 L. Chromatography buffer volumes up to 2000 L - TFF-systems (membrane area up to 0.2 sqm) - Filtration equipment Incorporation and execution of QbD-concepts and tools such as DoE and risk analysis to guarantee efficient, effective and robust purification. Evaluation and implementation of emerging DSP technologies and purification strategies. Establishing process data/knowledge for scale-up to API manufacturing to ensure scalability and process robustness. Established pilot-scale processes represent process confirmation for transfer and scale-up into GMP facility at external contract manufacturer (up to 11'000 L refolding volume). - Participation and support in the technology transfer - Review of GMP process documentation (batch records and executed batch records) - On-site CMO support during implementation runs in GMP facilities - Contribution to confirmatory activities for API manufacturing - Performance and supervision of all unit operations involved in preparative protein production in lab- and pilot-scale and supportive analytics. - Applied techniques include, but are not limited to: Inclusion body solubilisation and refolding, preparative protein chromatography by various principles (e.g. IEX, HIC, MMC, SEC), TFF, fill/finish, analytical methods for in-process sample characterization (e.g. gel electrophoresis, UV-Vis, SE- and IEX-HPLC, impurity assays.
Development of protein purification processes, scale up and tech transfer into GMP-Biomanufacturing facility.