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Confidential
- Head of Operations / Senior Manager Advanced Product Development
2012 - maintenant
• Individually managing operations within the Integrated Prefilled Drug Delivery Device and Integrated Hypodermic Safety Syringe business (9 direct reports, 35 associates)
• Spearheading all of supply chain accomplishments, increasing quality of activities and associated documentation from purchasing through receiving, storage, incoming and in-process QC inspection, production and material control all the way to final release
• Developed, validated and implemented enhanced and customized ERP solutions (SAP) specific to the strategic business activities
• Evolved Design History Files to a whole new level by structuring with accurate content, and detail in compliance with the most recent Medical Devices regulatory and customer requirements.
• Demonstrating a clear validation of commitment to quality by improving quality standards and daily execution to ensure full compliance with quality assurance and quality control standards for medical devices
• Audited by a registered Notified Body conducting surveillance audits for the FDA (No finding)
• Leading business, technical and industrial risk assessments (DFMEA, PFMEA, UFMEA)
• Advancing the technical knowledge of engineering teams in terms of sterile parenteral drug primary packaging and material assessment (Design Input Requirements for container closure integrity, drug delivery performance, sharps protection and safety, sterilization, sterility and sterile barrier system, drug compatibility and fluid path, biocompatibility, manufacturing, transportation and storage, aging, extreme operational conditions and and fill-finish integration)
• Supporting business in a broader capacity relating to customer integration and new product development activities
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APTAR STELMI SA
- Technical Project Manager - International Sales Technical Support
2008 - 2012
• Individually led large scale and long term technical and business development projects as a “solution provider” resulting in 8.24M€ additional sales revenue over the last 3 years (10.16% of the global turnover)
• Individually responsible for the comprehensive technical and quality support of 210 pharmaceutical (laboratories, glass and AID manufacturers) customers across 26 countries (US, EU, South Africa, Middle East, Russia, India, Asia-Pacific area)
• Identified unmet and evolving needs relating to customers requirements and market trends in syringes and advanced drug delivery systems components and materials, aseptic filling process
• Led development team to create over 5 novel ranges of products and services to meet pharmaceutical customers’ needs resulting in new business opportunities and ensuring a 58M€ key accounts portfolio
• Advanced the technical knowledge of STELMI in terms of sterile parenteral drug primary packaging and material assessment
• Analyzed and implemented process improvements and robustness to reduce cost of poor quality by 30%
• Designed and executed specific test methods and experiments relating to the functional performance of the pharmaceutical rubber closures (CCIT, biocompatibility, cleanliness, mechanical, physical and chemical properties)
• Supervised cross-functional teams of 10 engineers to industrialized existing and new products
• Developed business and production plans for new products from the early stage development phase to their commercialization notably to the US and Japanese biotech drug markets
• Carried out new supplier validation
• Led business, technical and industrial risk assessments
• Established strategic marketing surveys
• Contributed to the definition of the strategic development axis of the company
• Trained production and quality teams, sales and marketing forces
• Ensured marketing and technical conferences through international exhibitions and conferences (ISPE, PhamaEd, Marcus Evans, PDA, AAPS, A3P, Medtec, PFS of Americas, SFSTP, SMI, CHI, CPHI, Pharmapack, Interpack, customer seminars…)
• Sourced and evaluated equipments to simulate, assess, characterize the behavior of pharmaceutical primary packaging as part of the implementation of a new technical center
• Evaluated intellectually property landscape surrounding Glass/Plastic PFS, Pen Injectors, Auto Injectors, reconstitution devices
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Vista Research - SIL New York
- Medical Devices Specialist (Consulting)
2008 - maintenant
• Serve as a liaison to life science venture capitalists for a French company developing a vastly better way for high-level disinfection of diagnostic probes and medical instruments in collaboration with the faculty of the Standford Graduate School of Business
• Frequently interviewed by investment banks and health care consultants (LEK Consulting, Vista Research, Society of Industry Leaders, Morgan Stanley, Goldman Sachs, Jefferies & Co) for discussing market issues and evaluating injection devices to be commercialized
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Université de Rouen
- Part-time Lecturer
Mont-Saint-Aignan
2007 - maintenant
• Educated Masters Degree students in industrial affairs with and business orientation
• Taught courses in the MSc program on starting technology-based businesses and on the health care industry
• Livened up workshop in lean manufacturing, strategic marketing, intellectual/industrial property
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Sanofi
- Prefilled syringe and Advanced Injection Device Project Leader
Paris
2005 - 2008
• Assigned for quality and compliant product supply with the best service and at a competitive cost, keeping in check key success factors such as customer service, compliance mindset, market supply risk identification and mitigation
• Led industrial and financial performance continuous improvement (Objective Cost Design)
• Led and presented concept phase of stage-gated product development system to corporate managing team resulting in allocation of 40M€ for development and industrialization of new drug delivery devices
• Designed, industrialized and assessed outstanding advanced drug delivery devices and syringes resulting in the commercialization of 4 blockbusters via the implementation (design and validation) of 5 production lines including 35 plastic molding tools, 5 fully automated assembling machines equipped with high speed vision inspection system
• Set technical agreements and manufacturing contracts with Rexam France and Plastef as outsourced production partners
• Developed 3, 5 and 10-year product roadmap for drug delivery devices
• Delegated to the product regulatory compliance to international guidelines, FDA/CDER regulations, cGMPs, EP, USP & JP, ICH, ASTM, ISTA 7E, ISO standards (9001, 13485, 15378, 10993 & 14971, 11608, 8871…)
• Solved business obstacles by establishing and holding development capabilities through site-based resources resulting in a strong market expansion
• Founded a network of competences across partners and group manufacturing units within Industrial, Science and Medical Affairs and Pharmaceutical Operations
• Defined key strategies and identified specifications to meet complex business challenges such as high-tech innovation, generic manufacturing competitiveness, continuous improvement, new product introduction and sourcing, reliable product supply and compliance, product life-cycle management capacity planning and site portfolio strategy
• Supervised and audited suppliers and partners (rank 1 to 4)
• Designated as temporary production site associate manager to increase revenue and profitability after reorganizing the whole manufacturing plant via process flows and equipment enhancement going with better human resources allocation (50 employees, OEE boosted by 60% over 6 months)
• Responsible for 500K€ to 30M€ investment budget
• Led interdisciplinary project teams of 20 people
• Generated user requirement specification, risk assessment, qualification, CAPA, functional design specification, design V&V, OBS and WBS template documents
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Sanofi
- Quality Department New Technology Project Leader
Paris
2004 - 2005
• Ensured technological survey
• Identified, challenged and selected suppliers and equipments for QC/QA advanced techniques
• Designed, implemented and validated functional, chemical and mechanical tests and equipments
• Educated QC lab teams to the use of the novel techniques implemented
• Performed root cause investigation studies as part of market complaints
• Communicated with health authorities (AFSSAPS, FDA) to resolve market issues
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CRITT Analyses et Surface
- Engineering Intern
2003 - 2003
• Performed behavior assessment and surface analysis of materials submitted by customers from railway, pharmaceutical, automotive, edifice, maritime, environment industries
• Appraised metallic, plastic, elastomer, glass samples using microscopy techniques (SEM-EDX, FTIR)
• Conducted material aging and degradation experiments
• Carried out root cause investigation studies to characterize particulate contamination, surface delamination and strength to gamma & e-beam exposure.
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Johnson & Johnson
- Engineering Intern
New Brunswick
2001 - 2001
• Individually responsible for cosmetics pilot/industrial production scale transposition (up scaling) resulting in the launch of 2 new ranges of product commercialized over the brands ROC and Neutrogena
• Set up and validated SIP-CIP and SMED methods in order to improve industrial efficiency and quality compliance
• Allocated to lead the implementation of an additional production unit (building and equipments) intended for EVIAN novel cosmetic products
