Lausanne Metropolitan Area
From a childhood dream to a successful career, I'm a biologist turned 𝙝𝙚𝙖𝙡𝙩𝙝𝙘𝙖𝙧𝙚 𝙞𝙣𝙙𝙪𝙨𝙩𝙧𝙮 𝙚𝙭𝙥𝙚𝙧𝙩 with over 12 years of experience. My expertise spans across various aspects of the Pharma/Biotech business, from 𝙢𝙖𝙣𝙪𝙛𝙖𝙘𝙩𝙪𝙧𝙞𝙣𝙜 𝙨𝙞𝙩𝙚 𝙖𝙘𝙩𝙞𝙫𝙞𝙩𝙞𝙚𝙨 (aseptic filling, packaging, qualification) to 𝙂𝙈𝙋 & 𝙂𝘿𝙋 𝙌𝙪𝙖𝙡𝙞𝙩𝙮 𝙖𝙨𝙨𝙪𝙧𝙖𝙣𝙘𝙚 for companies with global operations (Products development, IMPs/commercial Manufacturing, C(D)MOs oversight, Market supply and Foreign trade). My natural curiosity and analytical mind have served me well, teaching me soft and hard skills such as multicultural communication, problem-solving, team, and project management, risk analyses, and more. I'm on a mission 𝙩𝙤 𝙢𝙖𝙠𝙚 𝙖 𝙧𝙚𝙖𝙡 𝙙𝙞𝙛𝙛𝙚𝙧𝙚𝙣𝙘𝙚 in people's lives with cutting-edge products in the pharma/life science industry. As a lifelong learner, I'm always looking for new adventures and opportunities to improve my leadership skills. Want to team up and see what kind of magic we can create together? Let's connect! ✅ Achievements: Led all qualification activities of a biotech production site (>5M€ CAPEX/year) Managed and improved quality oversight processes for >100 CDMOs Drove major quality processes implementation e.g., New regulations assessment (EU Annex 21, new CT regulation), Good Research Practice (GRP), Quality & Operations process mapping 📍 Key words: GMP, GDP, C(D)MO, manufacturing, leadership, problem-solving, innovation
• Diriger, encadrer et développer une équipe de spécialistes Qualité en charge de la gestion qualité de l’ensemble des produits sous licence pour les BU Pharma/Nutrition et BU Biosimilaires. • Participer aux activités de due diligence pour l’évaluation de nouveaux partenaires potentiels, en apportant une expertise Qualité et Conformité pour les deux Business Units. • Assumer le rôle de responsablt teechnique (RP / FvP / RT) pour Fresenius Kabi SwissBioSim GmbH, avec la responsabilité des processus GDP, de la qualification des CMO pour l'in-licensing, de la gestion des événements qualité et des changements, des indicateurs qualité (KPI) et du système de formation, en continuité avec le poste précédent. Périmètre & impact • Supervision qualité de plus de 30 sites de CMO et de plus de 55 produits • Contribution active au lancement de plus de 20 nouveaux produits
• Same activities as before, but adding, on top of Business Unit Pharma (generics) & Nutrition, the RP responsibility for Business Unit Biopharma (5 biosimilar products, 1 supplier and all customers/market units worlwide).
• Act as the Registered Responsible Person (RP / FvP / RT) for Fresenius Kabi SwissBioSim GmbH, ensuring full compliance with Swiss regulatory requirements and the Swissmedic manufacturing authorization (import, export, wholesale, and foreign trade of medicinal products). • Design, harmonize, and continuously improve GDP/GMP quality systems for generics across the product lifecycle. • Lead qualification and approval of 30+ CMOs and customers, including the establishment and maintenance of Quality Agreements, as well as planning and execution of audits and GMP/GDP trainings. • Oversee and coordinate the end-to-end management of quality events (deviations, changes, CAPAs, complaints, recalls), acting as a key interface with Business Units, Fresenius Kabi entities, CMOs, and suppliers. • Provide quality leadership for 15+ new product launches, ensuring readiness for market entry. • Define, monitor, and report quality KPIs, and regularly inform senior management through Quality Management Reviews. • Co-own the company training system, including definition of training requirements and oversight of compliance for the Business Unit Pharma.
Quality requirements (GMP, GDP and to a lesser extent GCP) oversight and implementation for clinical trials, Third-party manufacturer management (QTA, KPI), Quality processes continuous improvement • Ensure interpretation, implementation & harmonization of latest GMP quality requirements for investigational products in a complex matrix organization (R&D, manufacturing, quality, launch, third-party service providers), e.g., new EU CT regulation, EU Vol. 4 Annex 21 • Supervise quality levels of 100+ CDMOs, coordinating and supporting Merck local QA representatives for CDMOs qualification and control worldwide • Review and coordinate intra-/inter-company quality & technical agreements • Drive major quality processes within company resulting in significant synergies e.g., implementation of Good Research Practices, Development & manufacturing process mapping • Contribute to continuous update of Merck quality systems for development, clinical trials and GMP operations
Team management (KPI, Recruitment/On-boarding, SMART objectives, Budget adherence); stakeholders management (Quality Assurance, PMO, global functions) • Lead and develop a team of 8-10 engineers responsible for biotech manufacturing site qualification activities (infrastructures, equipment, HVAC, utilities, computerized systems). Total yearly CAPEX >10M €. • Be responsible for qualification processes continuous improvement • Coordinate activities related to qualification between all departments (Technical services, Quality assurance, Production, Quality control) • Subject Matter Expert (SME) during Health Authorities Inspections (2x FDA, 3x Swissmedic), successfully presented major production area revamping & equipment qualifications • Confirmed lead auditor (2 internal & 1 external audits performed with supervision of a co-auditor)
Complex packaging line qualification + process validation; Knowledge management and transfer; Quality & Lean management on shop floor • Project management responsible for Supply Operations-Packaging department (10 projects managed) • Creation and execution of qualification/validation strategies for 15+ equipment, from stand-alone labeler to fully automated packaging line, using risk analyses tools (FMECA, HACCP), • SME during Health Authorities inspections, successfully presented qualification strategy of brand-new packaging line (no observation) • Supervision of technicians and operators to ensure knowledge handover (up to 4 people) • Confirmed lead auditor (internal & external)
• Manage a cancer research project using a vast array of molecular biology techniques, observing deadlines and objectives • Coordinate the experiments involving several stakeholders. Organize and review the work of lab technicians • Gather the results, analyse and present the data (scientific articles and presentations at scientific meetings) • Work in a multicultural & regulated environment (adaptability) Technical competences: • Molecular biology: Real-time PCR, cloning techniques, site-directed and random mutagenesis, sequencing, Southern/northern/western blot, nucleic acid immunoprecipitation (ChIP, DIP) • Cellular biology: Cellular culture of murine nervous cells, yeast and bacteria cultures • Biochemistry: Dosage of catecholamines by chromatography (HPLC), ELISA, immuno-histo-chemistry During that time, I could also take several lessons in management, thus maintaining and deepening my knowledge in fields such as strategy and project management.
• Experience of a regulated work environment (GxP, ISO 9001, ISO 17025, ISO 15189) • Review/represent data & material flows, measure processes efficiency and plan improvements • Interview unit managers and collect information • Knowledge of clinical data management As an intern, I reviewed the processes within the enterprise and planned optimization. That position allowed me to work in a motivating environment. I could also improve my communication skills as I had to gather/analyze information from people working in various departments.
• Develop of a new clinical tool to assess the dangerousness of a yeast strain • Test protocols writing and execution • Daily contacts with healthcare professionals within an ISO-accredited institute (ISO 17025) • Presentation of my work at various scientific/medical meetings Following my MSc in Biology, I was hired to deepen my results in the medical field (resistance to antifungal treatments). I could work in one of Switzerland's leading university hospital for several months, thus benefiting from fruitful interactions with physicians, medical analyses lab directors,...