Directeur Site Industriel

Leading pharma company, 52,000 associates, 14 B$ in revenue

In charge of transitioning the development unit (100+ associates) into a commercial business model ($20MM turnover) and achieving successful qualification and scale-up of a biosimilar drug substance.

Main responsibilities:

• Plan and execute a transformation road map from a development activity to CMO-like operations. Prepare for Medical Health Authorities inspections,
• Kick-off commercial manufacturing and ramp-up production to 80% capacity,
• Manage tech-transfers for biologics molecules to CMO partners,
• Lead change management to enable a culture of safety, quality, delivery, and costs in a highly regulated environment,
• Oversee the development of CMC tasks relative to the drug substance manufacturing, including preparation of drug license submission documents (FDA and EMA).

Leading medical device company, 45,000 associates, 10 B$ in revenue

In charge of a P&L of €100MM and 700+ associates, manufacturing high-end dialyzers for chronic and acute markets. Sales and distribution over 100 countries.

Main responsibilities:

• Manage product development and product life-cycle activities,
• Develop and execute manufacturing strategy (CAPEX of €10MM/yr), including new products industrialization and production lines optimization,
• Turnover S/Q/D/C performance in a highly demanding environment,
• Manage complete value chain from critical raw materials CMO, through 2 manufacturing plants (process and assembly manufacturing) to gamma and ETO sterilization partners,
• Maintain high safety (OHSAS 18001) and environmental standards (ISO 14001).

Leading medical device company, 30,000 associates, 8 B$ in revenue

In charge of the operations of a €150MM budget and 800+ associates industrial plant manufacturing Prefillable Glass Syringes.

Main responsibilities:

• Develop and execute manufacturing strategy (CAPEX of $15MM /year), including new products industrialization and production lines implementation,
• Deliver increasing S/Q/D/C performance,
• Heighten Lean and Operational Excellence standards,
• Manage budget in a costs competitive environment (5% savings / year),
• Develop a leadership team of 10 associates including director positions.

In charge of the operations of a 200 MM units Hypak manufacturing workshop. Definition, planning and execution of production plans in a stringent and demanding S/Q/D/C environment, including highly regulated context (cGMP, 21CFR Part 210/211)

Key Achievements:

• Managed budget of $30MM, headcount of 200+ associates,
• Turned-around workshop performance (+10 points on OEE, productivity +20%),
• Re-structured management team, restored morale and leadership,
• Implemented successful Lean improvements (Pull flow, visual and performance management), recognized by an Operational Excellence award in 2014,
• Realized significant and sustainable costs savings ($2MM per year),
• Successfully managed relations with unions (week-end shift, manufacturing line closure).

Responsible for the definition, planning and execution of the plant's Operational Excellence strategy.

Key Achievements:

• Revitalized Lean Management System, including 5S program, Shift Start-up Meetings, suggestion system (KAS), visual management system (dashboards, KPI),
• Delivered continuous process flow (in-lining) on the high-flow 1ml line,
• Delivered "Batch Released Lead-time" reduction program including re-design of plant's batch master record. Re-structured quality organization and processes,
• Responsible for the Cost Of Poor Quality reduction program (-20% in 2011) leveraging on 6-SIGMA and Kaizen Events.

Appointed transition manager to lead the planning and execution of BD Pharmaceutical Systems IT Road Map spanning quality, R&D, manufacturing and supply chain systems

Key Achievements:

• Managed team of 7 direct reports and 4 indirect reports located in 4 countries (Mexico, Hungary, USA, France),
• Deployed worldwide CAPA and deviations (Trackwise) and MES solutions (Flexnet).
• Implemented full IT architecture and application services in green field plant (Hungary).

95,000 associates, 35 B$ in revenues

Promoted WW Program Manager with the assignment to set-up a Program Management Office (PMO) to roll-out corporate SAP / MES systems for the manufacturing plants of Volvo Construction Equipment

Key Achievements:

• Managed budget of $10MM over 3 years,
• Managed a group of experienced project leaders located in several countries,
• Implemented MES and SAP manufacturing in 2 plants (Sweden and USA).

In charge of the design, development and implementation of a corporate Supply Chain Management system for the spare parts business unit of AB Volvo

Key Achievements:

• Managed cross-functional and cross-cultural team of 15 members,
• Implemented IT systems in 4 distribution centers,
• Started-up and operated off-shore IT development (India).

Leader in Digital Identity & Security, 10,000 associates, 3 B$ in revenue

Leader of the WW implementation group in charge of implementing the company's global ERP in its subsidiaries: accountable for the Time/Costs/Quality objectives in a very demanding and challenging business environment.

• Management of project teams of 10 to 15 members in several countries: Singapore, USA and Poland

• As a team member, assigned responsibility to implement comprehensive ERP business processes in several international implementation projects (France, Germany, Mexico)