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Supply Chain Director

2 months ago

springfield, United States Evergreen Theragnostics Full time

Director of Supply Chain


About Us


Evergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, developing our own radiopharmaceutical products and providing contract development and manufacturing services for other radiopharmaceutical companies. We also operate our own cutting edge cancer research laboratories. The company expects rapid growth in the next few years.

Evergreen is a small team, where all team members support each other in a variety of activities. We are looking for team members who are motivated to take on new challenges and excited to help build the company. Partial equity-based compensation packages possible.


Responsibilities:


Strategic Planning & Management:

  • Independently design and implement processes and policies to enable planned CDMO business volume growth in both patient doses shipped and general manufacturing capacity
  • Oversee a team of 5+ people charged with logistics of patient doses direct to hospitals and clinical trial sites, isotope supply incoming to manufacturing, and raw materials inventory management
  • Collaborate with cross-functional teams, including client and internal Clinical Operations, Regulatory Affairs and CMC, to ensure alignment on clinical supply needs and priorities.
  • Liaise with manufacturing operations teams to plan for batch production and ensure all incoming isotope arrives on schedule and all raw materials are on hand to facilitate production
  • Oversee the selection and management of third-party vendors
  • Generate and maintain a clinical and/or commercial supply plan to drive manufacturing, labeling, and forecasting logistic supply activities across internal and external stakeholders



Logistics Oversight and Development:

  • Lead day to day support of CDMO customer shipments including scheduling, tracking, and managing product logistics and performing quality checks across the supply chain to ensure compliance
  • Manage the procurement and inventory capacity of all materials used in the manufacturing process to ensure adequate levels are constantly maintained
  • Oversee the isotope shipment process coming to the CDMO facility, in compliance with all applicable laws and regulations.
  • Act as a first line resource to manage the interface between functions pertaining to supply, transportation, logistics, and traceability issues for clinical and commercial products
  • Review upcoming inbound patient material and outbound drug product to ensure alignment with internal and external stakeholders
  • This position involves serving as the main point of contact for partners, ensuring on time, compliant, day-to-day shipment management, monitoring vendor performance through KPIs, and tracking budgets
  • Responsible for all processes associated with delivery, receipt, and distribution of clinical and commercial radiopharma drug products that will be manufactured within a state-of-the-art multi-product radiopharma manufacturing facility.


Quality & Compliance

  • Ensure timely and accurate financial reporting and forecasting related to clinical supplies
  • Implement and maintain robust quality systems and processes to ensure the integrity and quality of clinical trial materials.
  • Ensure compliance with all applicable regulatory guidelines, including FDA, EMA, and ICH guidelines.


This is a multidisciplinary role & this individual will need the ability to interface with all levels of the organization, including Manufacturing, Quality Assurance, QC, Engineering/Facilities, and Finance.



Qualifications:

  • Bachelor’s degree in a relevant subject matter
  • 6-10+ years of experience in logistics and supply chain, preferably within the pharmaceutical or radio pharma industry.
  • Experience with international and domestic shipments, including materials with special handling, including BOMs.
  • Excellent leadership and communication skills, and the ability to work collaboratively with cross-functional teams.
  • Strong analytical skills and the ability to provide strategic recommendations based on data.
  • Ability to work in a fast-paced environment and manage multiple priorities, while filling gaps as needed.
  • Strong understanding of commercial business, ideally in the pharmaceutical sector.
  • Ability to be productively assertive and able to lead without direct authority.
  • Track record of excellent judgment: an ability to make decisions independently and to know when appropriate to partner with senior management for decision-making.
  • Demonstrated ability to combine attention to detail with big picture perspective, operationalizing via excellence in project management and effectively managing multiple projects/priorities.
  • Must possess a "can do" attitude and be readily willing to roll up their sleeves to ensure timely and accurate delivery of deliverables