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Associate Director, Materials Management (2216-N-685-SC)

Company: ArsenalBio
Location: Hayward
Posted on: June 19, 2022

Job Description:

ArsenalBio's mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. Our products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments. Our people are our greatest asset, they bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.Arsenal Bio is looking for an Associate Director of Materials Management who is analytical, driven, strategic, and creative. Reporting into the Supply Chain Organization the Associate Director will be responsible for the start-up operations of the Materials Management Warehouse & Distribution operations. In this critical role, you will be part of a cross-functional team working on supporting production start-up activities such as the design, installation, testing, and validation of manufacturing equipment, processes, and the quality approach for this exciting technology. The Associate Director will have extensive knowledge in inventory management & reduction strategies, lean methodologies, cold chain management, GLP, ERP systems, and managing clinical and commercial projects for early stage and late phase drug product development, including IND/BLA/MAA submission and support of product launch.In addition, the incumbent will provide leadership and process expertise to staff members. Work with department and site leadership to develop and sustain a safe working environment, high performance and engaged team. The individual should possess a track record of successful relationship management, great communication skills, strong business and analytical acumen. This is a pivotal and highly visible role that engages with local operations, functions and extended leadership teams on a regular basis.What You Will Do:

  • Create an environment of strong team spirit, timely and effective communications, a sense of urgency, high motivation, and inspire teams to achieve goals in the immediate and longer-term
  • Be an active and visible change agent, promoting flexible and open mindsets to new opportunities
  • Establish strategic goals and objectives and maintain full strategic responsibility for the Materials Management organization
  • Drive collaboration within site and across network activities, cross-functional planning, and decision making
  • Accountable for the overall budget and financial performance of the Materials Management organization
  • Manage/support Warehouse & Logistics of raw materials in support of manufacturing operations
  • Manage inventory management system conforming to standard warehouse practice (Bar Code, FEFO, reorder triggers)
  • Manage and implement business continuity plans to support clinical and commercial operations
  • Develop and manage pick and pack system for supply kits to manufacturing groups utilizing a Bill of Material
  • Manage receiving system for both products and materials
  • Manage packaging and shipment of the final product
  • Implementation, process mapping and creation of materials management modules, and user acceptance testing (UAT) for ERP systems as it relates to receipt, inspection, disposition, inventory, kitting, and shipping of GMP materials
  • Lead strategic planning of materials management projects, including implementation of a new enterprise resource planning system (e.g., EBS Oracle, SAP, Microsoft Dynamics).
  • Monitor commercial/clinical inventory report for quantity, lot status, expiration dates
  • Rebalances inventories based on lot expiration and QA requirements, as needed
  • Develop and implement protocols and practices to ensure effectiveness and efficiency of strategic initiatives an inventory/warehouse management
  • Drive continuous improvement of the supply's movement, warehouse level optimization, kitting and kanban processes
  • Experience leading and preparing department for PAI
  • Knowledge of material resource planning and scheduling
  • Develop inventory strategies that minimize financial impact and develop systems to manage materials across multiple clinical studies
  • Knowledge of cold chain validation program to support USA and EU clinical and commercial programs
  • Proactively promote positive Safety Culture and cGMP operating principles
  • Provide managerial guidance and leadership to frontline leaders for non-routine issues
  • Provide significant guidance for the development of individual contributors and the building and sustainment of a high-performance team
  • Perform or provide oversight to department and network-related project activity that may require investigating, analyzing, formulating solutions, documenting processes, and communicating results
  • Ensure cGMP compliant and lawful execution of all responsibilities
  • Ensure sufficient resources are in place to compliantly and safely meet site and department objectives
  • Additional duties may be assignedWhat You Will Bring:
    • Bachelor's Degree or commensurate experience preferred
    • Minimum 12+ years of relevant experience in GMP Warehousing and Distribution operations with 5 years of progressively increasing leadership accountability
    • Experience in Biotech or pharmaceutical or personalized health care experience or cell and gene therapy manufacturing is desired
    • In-depth working knowledge of inventory management principles, and cold-chain distribution
    • DOT, IATA, International shipping expert
    • Demonstrated history of exceptional people development skills
    • Extensive experience and working knowledge of MRP systems
    • Expert knowledge in ERP systems
    • Strong business acumen - the ability to understand challenges through the eyes of the regional business leaders
    • Strong leadership and collaboration skills
    • Influencing skills - the ability to persuade others to change behavior in pursuit of a common goal
    • Strong verbal and written communication skills, with the ability to confidently present complex information to senior executives
    • Strong project management capabilities
    • Demonstrated learning agility, and the ability to improve both yourself and the people around you
    • Creates a positive, diverse, and inspiring work environment
    • Strong critical thinking and problem-solving skills
    • Demonstrated continuous learning and development mindset
    • Customer centric mindset striving to find the best solution for the business
    • Demonstrated negotiation and influencing skills
    • Proven ability to meet tight deadlines, multi-task, and prioritize workload
    • Ability to communicate effectively with both technical and non-technical team members
    • Strong experience in reviewing business requirements and problem statements
    • Highly motivated, self-driven, capable of defining requirements and developing procurement processesArsenalBio prioritizes the providing of a safe and healthy workplace that is consistent with COVID-19 public health guidance and legal requirements. In order to protect our employees and visitors, we require all visitors (candidates) and employees to present proof of being fully vaccinated against COVID-19 when coming onsite.We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity, and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.

Keywords: ArsenalBio, Hayward , Associate Director, Materials Management (2216-N-685-SC), Executive , Hayward, California

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