Career

Orchestrating end-to-end site selection, capacity evaluation and supply chain strategy for product portfolios.

• Governance and leadership: leading the sourcing process from initial scoping and data collection through to the decision, bridging portfolio analysis and technical transfer execution. A connector between technical teams, product strategy, development, procurement, external partners and decision-making bodies; facilitating cross-functional squads that bring together site SMEs, finance, quality, regulatory and supply chain partners.
• Portfolio and capacity: driving structured portfolio reviews and developing internal tools to improve capacity visualisation in long range planning.
• Make versus buy: coordinating make-vs-buy decisions, weighing internal capacity against external options, regionalisation strategies and supply chain resiliency.
• Risk and mitigation: assessing technical fit, transfer risks, facility constraints and operational dependencies, and proposing mitigations for a robust supply chain design.

Overarching end-to-end leader for technical transfers, bridging global product teams, receiving sites, donor sites and analytical functions. Coordination of manufacturing processes across drug substance, drug product, packaging, assembly and sterilisation. Setting timelines, managing cross-functional technical teams (MSAT, quality assurance, supply chain, operations) and ensuring alignment with regulatory submissions. Escalating resource constraints and managing product handovers when portfolio demands required prioritisation.

Management of packaging transfer projects under GMP conditions: tablets and powders for oral suspension, auto-injectors and vials, for both synthetic and biological medicines.

Management of a technical transfer project between Roche and a European contract manufacturer. Contribution to the programme to shorten the lead time of technical transfers.

Management of analytical transfer projects under GMP conditions. Coordination of the quality control teams and the experts to keep planning and execution of the transfers efficient; writing of the transfer documentation.

• Transfer of clinical and commercial analytical methods from a group site in Asia to two European sites, and takeover of the ongoing stability studies
• Transfer of commercial analytical methods to a contract laboratory in Europe

Management of three analytical teams (12 to 15 people, analysts and laboratory supervisors) in a GMP environment. Release and stability testing of commercial parenteral biological products. Responsible for container closure integrity testing (helium leak and blue dye) and for capillary electrophoresis. Point of contact for the health authorities during inspections and internal audits. Writing of specifications, methods, SOPs and deviation reports.

• A new qualification concept for laboratory equipment
• Analytical transfers with a group site in the United States and a European contract manufacturer
• Quality control planning and the introduction of key performance indicators

Management of a team of five laboratory technicians in a GMP environment, deputy to the group leader. Review of release and stability results for commercial solid and parenteral products (physical tests, capillary electrophoresis, HPLC, spectroscopy, SDS-PAGE, western blot, IEF, thin-layer chromatography). Management of qualified equipment, analysis of complaints and counterfeits.

• Project lead for a web application to plan the analytical workload of the quality control laboratories
• Analytical transfer with a group site in the United States
• Move of the GMP laboratory from Basel to Kaiseraugst

Validation of analytical methods, liaison with regulatory affairs on quality questions, monitoring of the pharmacopoeias.

Development of a near-infrared spectroscopy method to monitor a cell culture, of a Matlab routine to identify counterfeit tablets and capsules, and Raman spectroscopy.

Development of a method to extract and purify apple chalcones: solid-phase extraction, high and ultra performance chromatography, UV and mass spectrometry.

Clinical research, completion of case report forms, a study on the readability of consent forms.

Review and improvement of the laboratory equipment logbooks; reorganisation of the qualification files for production equipment.

Preparation and marking of mock examinations for first-year pharmacy students.

Stock management, labelling, counter service.

Thesis: “Dihydrochalcones of the apple: extraction, separation and medical value”. Read the thesis (PDF)

Layout of the paper, and a complete rebuild of the association's website.

In charge of communications and of student parties: posters, video clips, and the running of the Pharmacy Banquet (800 guests).

Nogha Consulting, Section Urbaine, Crèche Le Petit Prince (Basel), Le Comprimé. See the Development page.

The presentation film on Good Laboratory Practice and the official film of the Strasbourg Faculty of Pharmacy. DVDs of the Pharmacy Banquet 2005, 2006 and 2007 (double DVD box set): the whole project, from cameras and editing to the DVD interface and the sleeves. See the films.

A team advocacy contest with Frédéric Hecht and Benoît Andlauer: “Livrés aux chiens”. Read the plea (PDF)