Senior Director, Supply Chain
PharmaBiotechClinical ResearchQuality Assurancegmpcdmemacro
Job description
We are seeking a highly motivated Senior Director, Supply Chain reporting to our VP of Operations who will lead and oversee the buildout of our Supply Chain organization. This individual will be responsible for developing and implementing a comprehensive Supply Chain Management strategy and business processes that will allow the organization to scale effectively and meet the needs of internal and external stakeholders and customers. This individual will oversee patient supply and material planning, materials management, inventory control, product tracking (chain of identity and chain of custody), import/export permits, shipping/receiving, and cold chain logistics of personalized cell therapies throughout our manufacturing network. This individual will also be responsible for interpreting and analyzing demand and usage requirements of various operating supplies, general and critical raw materials, components, equipment, and maintenance supplies. This is a multidisciplinary role and requires proven leadership to drive effective communication, coordination, and collaboration across relevant cross functional groups at all levels of the organization, including Manufacturing, Quality, MS&T, QC, Process/Analytical Development, Training, Engineering/Facilities, HS&E, Finance, IT, and Commercial Sales. The successful candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows. Responsibilities
Lead, direct, coach, and develop an effective Supply Chain organization supporting the manufacture and release of autologous and allogeneic cell therapy products across a matrixed manufacturing network by developing, implementing, and executing strategic Supply Chain Management business processes
Lead the Supply Chain organization by effectively interfacing and collaborating with key stakeholders and functions to drive business transformation and process optimization at all levels across the organization
Develop and continually update efficient business processes for GMP production planning, production, supply chain management, warehousing, and distribution of finished product and raw materials
Establish a robust Global S&OP that incorporates multi-product, multi-client production and material planning business processes across our manufacturing network by working closely with relevant business stakeholders
Oversee the implementation of the Cellares corporate sourcing and procurement strategy by establishing robust processes and procedures, including the evaluation, selection, and implementation of an enterprise-wide ERP solution
Oversee the creation and execution of an overall Supply Chain systems roadmap for the organization in close collaboration with relevant stakeholders
Create and implement tools and processes for clinical trials and future commercial requirements from apheresis operations/collection to infusion incorporating logistics, Chain of Custody (COC), Chain of Identity (COI), real time scheduling and tracking, and capacity management
Champion quality, safety, and compliance culture; demonstrate critical thinking skills and high reliability mentality, ensure work is completed according to cGMP guidelines and business procedures
Build Operational Excellence capabilities through training, and continuous improvement tools and events such as 5S assessment and Kaizen, applying boots on the ground and digitalization approaches
Accountable for monitoring the performance of the supply chain organization and the manufacturing network with respect to local and integrated supply chain network objectives
Work closely with other functional areas to develop and execute against the strategic plan for our manufacturing network
Establish key stakeholder relationships with internal and external stakeholders Requirements
Bachelor's degree in supply chain, life science, engineering, or related field required
15+ years of experience within a cGMP environment in the biotech/biopharma industry (operations, supply chain, manufacturing, ERP, digital/data technologies, or quality) with 10 years of Supply Chain support
5+ years of leadership experience with 5+ years of experience supporting ERP systems
Cell/Gene Therapy or CDMO experience preferred
Ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment
Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members
History of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning
Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability
Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization
Experience with Operational Excellence and/or Lean Manufacturing
Excellent organizational and communication skills
Self-motivated and passionate about advancing the field of cell therapy
Self-awareness, integrity, authenticity, and a growth mindset
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