Logistics Specialist

The Position

The Logistics Specialist is responsible for the planning, coordination, and execution of distribution for Arrowhead's products. This includes managing budgets, organizing schedules & routes, depot supplier management, facilitating imports/exports, and ensuring legal/regulatory compliance is always adhered to. The position will interface cross-functionally with Clinical and Commercial Planning, Manufacturing, Procurement, QA, and a network of CMOs to provide logistic support in execution of production plans. In this role, you will use your experience with cGMP and GxP environments and help Arrowhead build a robust logistics infrastructure, optimizing the overall supply chain to help achieve the ultimate goal of delivering Arrowhead's pipeline to patients.

Responsibilities

• Performs all responsibilities in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management

• Implements reliable transportation & storage relationships and distribution methods and protocols

• Executes domestic and international distribution of temperature-controlled products (API, DP and finished goods), ensuring safe compliant, on-time delivery and exemplary customer service

• Facilitates and coordinates with warehouses, logistics carriers and couriers, and customs brokers regarding all aspects of transport service, including but not limited to order placement, reviewing shipping documents, tracking, receipt confirmation, and ensuring the physical and thermal quality of the product during transit

• Manages import and export process including ensuring compliance with local and regional import/export regulations, particularly for US and EU

• Serves as liaison with Clinical and Commercial Planning for distribution order management, transportation, delivery, and resolution of challenges in support of the production schedule with CMOs and internal manufacturing sites

• Establishes/optimizes operational procedures for activities such as verification of incoming and outgoing shipments, temperature data logging, and on-time/at-temp delivery performance

• Develops, implements, and enforces SOPs for all aspects of logistics management, including import and export activities, transportation risk analysis and shipping validation for Finished Goods

• Supports Supplier Management by managing and assessing courier vendors' performance and reporting operational metrics (KPIs), as well as any regulatory reporting requirements related to transportation and logistics activities; assists with recurring business reviews

• Consult Sourcing in the selection of courier vendors to determine optimal design and cost for regional/affiliate logistics operations

• Leads and measures processes to ensure logistics operations are completed with excellence

• Collaborates with corporate and facility-based Quality counterparts to ensure audit readiness and process control for all logistics activities. Participates in regulatory audits as needed

• Coordinates with Quality team on deviations/CAPA for incidents that occur during transportation

• Supports and oversees daily and ongoing expenses to ensure that financial capital is used effectively and is fiscally responsible

• Performs other duties as assigned, in a dynamic environment

Requirements:

• Bachelor's degree in supply chain, logistics, science or other relevant discipline

• 7+ years progressive experience in supply chain within the biotech/pharmaceutical industry

• 5+ years in a logistics management role for clinical and/or commercial products, including experience in import/export processes, lot-level inventory management, chain of custody and traceability, budget management, warehousing technologies, and temperature-controlled distribution protocols, in a regulated pharmaceutical/biotech environment

• Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, 21 CFR Part 11, and Annex 13) and knowledgeable of relevant commercial laws and regulatory guidelines

• Experience working in a complex supply chain organization within the biopharma industry

• Strong understanding of import/export requirements and customs practices for US and EU

• Strong ability to flex between clinical/commercial processes

• Experience in vendor oversight and managing external partnerships and relations

• Experience with biologics (cold chain) and/or small molecule supply chain

• Experience in change management, deviation investigation, and CAPA implementation

• Ability to foster a culture of continuous improvement and operational excellence and perform as an influential leader without positional authority

• Strong ability to collaborate and build strategic relationships with internal (Clinical, Commercial, Quality, CMC, etc) as well as external (3PLs, CMOs, Couriers, etc.) stakeholders

• Ability to work effectively in cross-functional and multi-cultural teams

• Excellent organizational skills, enough to multi-task in an extremely fast-paced environment with changing priorities while maintaining attention to detail

• Strong analytical, problem solving and critical thinking skills

• Proficient in Microsoft Office applications and an ERP system

• Experience in vendor oversight and managing external partnerships and relations

• Familiarity with risk management tools (FMEA, etc)

Preferred:

• Experience with a warehouse management system

• Experience with lane risk assessments, and shipping lane/process qualification including IQ, OQ, PQ

• Direct experience with US customs audits