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Chief Operating Officer (Coo)_Biologics

Vietnamworks' Client · Hồ Chí Minh
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Loại hình
Toàn thời gian
Hình thức
Tại văn phòng
Cấp bậc
Cấp cao
Ngành nghề
Ngành nghề khác
Mức lương
Thương lượng
Địa điểm
Hồ Chí Minh, Hồ Chí Minh, Hồ Chí Minh

Tổng quan

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

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