Benjamin Lewkowicz
Msat Specialist - Emo @Ipsen
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WORK HISTORY
Msat Specialist - Emo @Ipsen
Ville de Paris, FR
Conduct and evaluate results from experiments and studies to meet project goals and objectives in support of liposomal manufacturing- Trained in Onivyde GMP manufacturing process to support the manufacturing group as required- Support continuous process verification program for commercial product- Conduct root cause analysis during quality investigations with a cross functional team- Review and author the technical and quality system documents such as investigation reports, change controls, protocols as required- Present experimental data and results to project teams- Be involved in manufacturing data trending and evaluation of results- Generate and maintain thorough and accurate documentation including experimental methods, observations, data, and results in accordance with GDP and in support development and cGMP activities- Actively participate in cross functional technical discussions- Follow safety practices and procedures; uses personal protection equipment (PPE) appropriate to the type of hazard and exposure potential. Actively participates in identifying and resolving safety issues- Support QC liposome testing as required- Take part in FDA regulatory inspection- Involved in Annual Product Quality Review
EDUCATION
Université de Cergy-Pontoise
Licence (par équivalence)
École de Biologie Industrielle
Master 2 (M2)
Lycée Galilée
Baccalauréat scientifique
ABOUT BENJAMIN LEWKOWICZ
Biopharma MSAT & Program Management Specialist | Driving Operational Excellence, Process Optimization & Global Collaboration I am a bioprocess & operations professional with + of experience in GMP manufacturing environments across, and the, specialized in process optimization, Continued Process Verification (CPV), and operational excellence. My career spans technical and, where I deliver data-driven solutions that enhance efficiency, product quality, and compliance. Having worked with global teams and CMOs across three countries, I thrive at the intersection of technical expertise and project management—bridging science, operations, and strategy to streamline complex processes and achieve measurable results: GMP Manufacturing & Compliance – Deep knowledge of FDA/EMA standards, with hands-on experience in biologics and vaccine manufacturing. Process Optimization & CPV Leadership – Improved batch yield by +%, reduced lead times by %, and uncovered $ cost-saving opportunities through Lean, statistical analysis, and workflow standardization. Cross-Functional & International Collaboration – Coordinating teams across MS & T, Quality, Regulatory, Manufacturing, and CMOs to align strategy and deliver results. Project & Program Management – PMI-certified, experienced in leading global initiatives from supply chain optimization to lab efficiency projects.@ Leading CPV program, boosting yield and ensuring regulatory compliance. Standardized global shipment workflows, reducing lead times and strengthening CMO partnerships. 🧪 Drove Lean Six Sigma initiatives in MS & T labs, cutting turnaround time and costs. I’m passionate about advancing biotech & pharmaceutical manufacturing through innovation, efficiency, and cross-functional leadership. If you’re interested in discussing process optimization, operational strategy, or future trends in biopharma, let’s connect!
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