What are the responsibilities and job description for the Director of Supply Chain position at Evergreen Theragnostics?
Director of Supply Chain - On Site Role, 5 Days a Week in Springfield, NJ
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. 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.
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