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Head of Supply Chain Operations

Il y a 2 mois

Paris, Île-de-France Cellectis Group Temps plein

The Head of Supply Chain Operations is responsible for overseeing the comprehensive supply chain activities at Cellectis Group, reporting directly to the Executive Vice President of CMC and Manufacturing. This role is pivotal in managing the Manufacturing and Distribution supply chain for cell and gene therapy products. Key responsibilities include:

  • Comprehensive planning, procurement of materials, and overall supply chain management for cell and gene therapy products produced at Cellectis' facilities,
  • Management of materials, including warehousing, inventory oversight, product tracking (chain of identity and chain of custody), import/export compliance, shipping/receiving, labeling, and cold chain logistics,
  • Coordination of production planning, scheduling, and material preparation activities,
  • Ensuring the supply of investigational products, secondary/tertiary labeling, and delivery to clinical trial sites across various jurisdictions, adhering to regulatory requirements,
  • Planning and managing the supply of gene/cell therapy products and ancillary materials to external partners according to established schedules,
  • Oversight of contract manufacturing organizations (CMOs) and other external service providers.

Furthermore, the Head of Supply Chain Operations will develop supply strategies that align with the company's objectives, ensuring timely and compliant delivery of products to patients within a GMP environment. This role involves collaboration with supply and warehousing teams at both US and EU manufacturing sites, and engagement with cross-functional leadership and subject matter experts from various departments including Manufacturing, Regulatory Affairs, Clinical Operations, and Quality Assurance.

Key Responsibilities

Responsibilities encompass, but are not limited to:

  • Leading the Global Supply Chain function and team,
  • Formulating a comprehensive sourcing strategy for raw materials and components, while implementing processes for continuous evaluation of supplier performance in terms of cost, quality, and compliance,
  • Collaborating with Legal and Quality teams to establish supply strategies and service agreements with providers, ensuring clarity in expectations and compliance,
  • Creating an integrated demand and supply plan from raw materials to final distribution, in partnership with clinical operations and quality teams,
  • Working with Quality Control and Global Manufacturing to develop effective production planning processes,
  • Managing relationships with external partners for the import, storage, and distribution of clinical goods, ensuring timely delivery,
  • Optimizing internal capabilities to meet clinical and manufacturing demands,
  • Establishing robust tracking systems for chain of custody,
  • Leading the Sales and Operations Planning (S&OP) cycle and addressing critical risks and issues,
  • Supporting production-related investigations to ensure adherence to internal and regulatory standards,
  • Overseeing the implementation of corrective action and preventive action (CAPA) projects,
  • Escalating pertinent issues to key stakeholders,
  • Promoting a culture of compliance and excellence in environmental, health, and safety practices,
  • Developing and managing a dedicated budget,
  • Implementing metrics to monitor project completion and service performance,
  • Crafting a vision for a global approach to supply chain deliverables in collaboration with other stakeholders,
  • Delivering business outcomes through informed decision-making,
  • Traveling as necessary to fulfill job responsibilities,
  • Performing additional duties as assigned by the company.

Core Competencies

  • Exceptional organizational and project management abilities,
  • Capacity to manage diverse and complex workloads while multitasking effectively,
  • Strong collaborative skills with a proven track record of leading cross-functional teams to achieve objectives,
  • Ability to thrive in a fast-paced environment with competing priorities,
  • Proficiency in MS Office applications and familiarity with ERP systems,
  • In-depth knowledge of international logistics standards and regulations,
  • Excellent communication skills in English and French, with strong interpersonal and leadership capabilities,
  • Proven ability to build and maintain strong relationships with internal and external partners,
  • Strong problem-solving and conflict resolution skills.

Requirements

  • A minimum of a Bachelor's Degree in Life Sciences or Engineering,
  • At least 15 years of experience in the pharmaceutical or biotechnology industry in a Technical Operations role, with substantial experience in cold-chain distribution of investigational products across multiple jurisdictions.

Work Environment

This is a full-time position that requires onsite presence.