Chief Operating Officer (Coo)_Biologics

1. Bio Business Unit setup & Project/Investment Management
• Lead the roadmap for establishing the Bio Business Unit from setup through commercial operation.
• Build the business/operating model, organization structure, headcount, people plan and the KPI/reporting system.
• Lead the preparation and control of the business case, master plan, timeline, resources and readiness milestones.
• Contribute to the direction of facility, cleanroom, utilities, equipment, warehouse, material/personnel flow and capacity from an operations perspective; work with the Project Office/Engineering/Science/QA to ensure the design fits commercial objectives.
• Manage contractors/suppliers/partners within the delegated scope; monitor FAT/SAT, commissioning, qualification/validation and handover to operations.
• Prepare operational readiness, inspection/audit readiness and the conditions required to bring Bio into operation.
2. Commercial Strategy, Portfolio & Launch
• Develop and execute the commercialization strategy and portfolio lifecycle together with the relevant functions.
• Define launch readiness across supply, manufacturing, quality, regulatory, cost, capacity and people.
• Manage the launch timeline and portfolio priorities, and coordinate Business/Marketing/RA/QA/Science to bring products to market on target.
3. Establishing & running the Operations system
• Build the Bio operating model: organization, processes, KPIs, reporting system and decision-making mechanism.
• Run S&OP, Demand/Supply Planning, Manufacturing, Engineering/Utilities, Warehouse and other operating resources.
• Ensure supply capability, OTIF, production reliability, capacity utilization and business continuity.
4. Supply Chain & Operational Excellence
• Build a supply chain suited to Bio specifics: raw materials, cold chain, inventory, supplier continuity and logistics.
• Manage CAPEX/OPEX, unit cost, productivity, yield, OEE, RFT, waste and cost of poor quality.
• Drive Lean/continuous improvement, digitalization/MES/ERP and plant capability optimization.
5. Quality, Compliance, EHS & Biosafety
• Ensure operations comply with GMP/GxP, biosafety, EHS and applicable legal requirements.
• Work with QA to maintain the quality system
• Lead operational readiness for audits/inspections and manage business/operational risks.
6. Business Development & Strategic Partnership
• Identify and evaluate opportunities for strategic cooperation, licensing, co-development, contract manufacturing or other suitable partnership models.
• Lead/co-lead commercial/operational due diligence; work with the CSO on scientific/technical due diligence.
• Build relationships with partners, technology suppliers and stakeholders to create competitive advantage.
7. Governance, Risk & Stakeholder Management
• Establish the governance of the Bio Business Unit; report periodically on business performance, risk, investment and operational readiness.
• Proactively identify and address risks in supply, quality, technology transfer, finance, people and business continuity.
• Work closely with the CEO, CSO, QA, RA, Finance, HR, Business and other relevant units.