The Role
The Senior Director, Supply Chain leads and develops the Supply Chain organization, implementing strategies for efficiency in materials management, logistics, and production planning within a biotech environment.
Summary Generated by Built In
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.
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
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
Skills Required
- Bachelor's degree in supply chain, life science, engineering, or related field
- 15+ years of experience within a cGMP environment in biotech/biopharma
- 10 years of Supply Chain support experience
- 5 years of leadership experience in Supply Chain
- 5+ years of experience supporting ERP systems
- Cell/Gene Therapy or CDMO experience
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The Company
What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit. The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope. Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale. Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need. The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
