Agenus

Senior Director / Director, Global Supply Chain

US-CA-Berkeley
Job ID
2017-1336
Category
Manufacturing

Overview

The Director, Global Supply Chain will be responsible for the strategy, development, implementation and direction of the global end-to-end supply chain for Agenus Inc commercial and clinical products. This individual will work closely with senior leadership to enhance materials management, contract manufacturing, procurement, supply chain and logistics capabilities as the company executes clinical trials, secures commercial product approvals, grows the product pipeline and expands the business nationally and globally.

 

Responsibilities

 

  • Develop and communicate Supply Chain vision, strategic direction, and resource requirements sufficient to deliver robust global supply solutions and distribution channels.

 

  • Interface directly with the Sales and Operations Planning (S&OP) departments.

 

  • Oversee Forecast planning and inventory management of all drug products in the pipeline, both internal and acquired through commercial agreements. In addition, provide Forecast planning and inventory control of all intermediates and final products.

 

  • Oversee product purchasing and planning at contract manufacturing and logistic suppliers. Includes establishment and oversight of rolling forecasts for clinical and commercial products, and coordination of clinical packaging, logistics and labeling operations for drug product.

 

  • Establish, oversee, and manage the Supply Chain Group sufficient to communicate both internally and externally Master Production Schedules for drug products relevant to domestic and international markets. This includes a Master Production Forecast / Plan for all products.

 

  • Establish key Supply Chain interfaces with Clinical Operations, Quality Assurance, Regulatory Compliance, Sales & Marketing, Commercial and Financial Planning and Analysis (FP&A) ensuring sufficient inventory, demands and Forecasts are aligned at both the operational and revenue levels.

 

  • Initiate and participate in strategy discussions (at departmental, global and partner levels) to ensure that decisions align with agreed upon corporate mission, business direction/goals and processes.

 

  • Identify, recruit, develop and retain reporting managerial and functional staff. Initiate methods to encourage effective leadership, decision-making, collaboration and innovation.

 

  • Transition the Supply Chain organization to a fully commercial biologics compliant level of performance and excellence with vetted inventory flow and product distribution channels.

 

  • Oversee the planning, review, and implementation of clinical trial materials supply including design and preparation of packaging and labeling; material warehousing and control; and clinical trial materials distribution, storage and reconciliation.

 

  • Develop and prepare long and short-range Supply Plans, including strategic make vs. buy analyses and capital investment plans.

 

  • Establish and implement inventory policy and materials risk mitigation strategies.

 

  • Negotiate, create, review and oversee Supply Agreements and Contracts with vendors and partners.

 

  • Coordinate the execution of purchase orders for commercial API and finished products as approved and agreed upon.

 

  • Serve as the technical lead / SME for supply and distribution on Commercial Launch teams and other forums as appropriate and assigned.

 

  • Support and encourage key communication to all internal departments regarding logistics and scheduling.

 

  • Actively build and maintain relationships within and across functions.

 

  • Support new product initiatives, assign resources and provide guidance as requested.

 

  • Partner and collaborate with other Senior Management to achieve and continually maintain maximum operational efficiency, intra and inter departmental coordination, and initiative / projects prioritization.

 

  • Develop and manage annual Operating Budgets for responsible Cost Center(s) and assure maximum functional area output with minimum cost and resource burden.

 

  • Initiate and coordinate quality improvements, Operational Excellence techniques, business process design, budget analyses and cost reduction processes / programs sufficient to ensure that the most effective ‘best practices’ are in place.

 

  • Prepare management reports, metrics, presentations, KPI’s sufficient to communicate and measure functional area performance.

 

  • Provide expertise and oversight on the development, review, approval, and follow-through of investigational new drug application technical sections of regulatory submissions as they relate to packaging, labeling, shipping, and distribution of clinical and commercial supplies.

 

  • Ensure that Supply Chain is in compliance with all supply and distribution Corporate policies and that all Company products comply with Federal, local and international laws and accepted practices of supply and distribution of goods, both for import and export of investigational and commercial pharmaceutical products.

 

  • In collaboration with Quality and Regulatory functions, develop and implement recall procedures of both clinical and commercial products

 

Qualifications

  • +20 years biotechnology, pharmaceutical, chemical, and / or medical device supply chain experience required. Familiarity with manufacturing operations and processes for biologic and Vaccine products including API (drug substance) and finished goods (drug product) production. Cold chain logistics experience a must.

 

  • BS / BA or higher in science, business or Supply Chain Management.

 

  • Graduate degree (MBA) and / or equivalent experience and education in strategic leadership and business preferred.

 

  • Strong supervisory / managerial leadership experience of senior-level supply chain professionals, technical contractors and expert consultants highly desired.

 

  • American Production and Inventory Control Society (APICS) Certification highly desired.

 

  • Technically proficient in industry standard systems / software applications for project management and inventory management, including Enterprise Resource Planning (ERP), Disaster Recovery Plan (DRP) and Management Service Provider (MPS) applications.

 

  • Outstanding managerial and employee development skills. Strong executive leadership skills, communication and business partnering ability. Proven strategic thinker and experience building effective organizations.

 

  • Ability to comprehend high-level business strategy objectives and effectively develop / execute ‘roadmaps’, milestones, detailed implementation plans and KPI’s.

 

  • Strategic, in-depth understanding of Supply / Production Planning; Procurement; Materials Management; Materials Handling / Logistics; Warehousing / Storage; Distribution; ERP / Business Systems; Validated Systems; and Data Management.

 

  • Demonstrated ability to create and manage work plans and timelines. Able to effectively handle multiple tasks and priorities in a fast-paced environment.

 

  • Superb time management and communication skills.

 

  • Strong interpersonal skills and ability to work with others in a positive, collaborative manner. Ability to work well on cross-functional basis internally and with business partners.

 

  • Comprehensive understanding and expertise of GMP’s, Gross Domestic Product (GDPs) and other regulatory requirements sufficient to establish compliant clinical / commercial stage supply chain operations, and contribute towards product development / licensure activities.

 

 

  • Experience with drug substance / drug product shipping validation (cold-chain and ambient), including drug product packaging for domestic and international shipments, materials tracking, and multi-national distribution.

 

  • Regulatory agency interaction experience and communication skills with emphasis on BLA, NDA / MAA application review / negotiation and site inspections desired.

 

  • Ability to address diverse technical challenges with a hands-on approach, in areas including packaging, inventory management, warehousing, distribution, and product returns / product destruction.

 

  • Previous management of contract manufacturing / contract testing organizations and Third-Party Logistics (3PL) providers.

 

  • Ability to interpret and translate manufacturing supply chain requirements from clinical protocols and plans.

 

  • Experience in labeling, labeling requirements and packaging for US, EU and ROW markets.

 

  • Strong financial acumen with ability to perform detailed cost analyses, manage budgets, perform make vs. buy scenarios, and identify areas for cost reductions.

 

  • Must have ability to travel to vendor / partner sites (domestic / international) and attend meetings, seminars, and training sessions as required to maintain competitive edge.

 

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