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Supply Chain Lead
Job Opportunity at
Spark Therapeutics, Inc
Posted on Jun 16
The Supply Chain Lead is relied upon to maintain a holistic understanding of the demand and supply dynamics affecting Spark’s US product portfolio. This strategic role combines aspects of product strategy, procurement, supply chain planning and logistics for clinical and commercial supply of novel gene therapies.
The Supply Chain Lead is responsible for supporting launch and post launch product strategy delivery for the US Market. S/he will drive and execute supply chain and operations planning for the U.S region.
facilitating the Sales, Clinical and Operations Planning Process
aligning both long & short term production plans with internal/external demand signals & production capacities
scenario planning to optimize supply strategy and investment decisions
supporting development and implementation of novel order-to-cash strategies and distribution models.
managing third party logistics providers, WIP and Finished goods inventory.
maintaining plans across software platforms.
S/he is responsible for collaborating with cross functional team members and outside vendors to ensure reliable, accurate, and consistent supply, purchasing coordination, material movement, risk and inventory management. Works with internal and external cross functional stakeholders to achieve most efficient pathways to streamline launch and supply time lines while ensuring regulatory compliance for product movement on a global scale with primary focus on the US market.
Facilitates and completes daily, weekly, monthly Supply Chain and Operations Planning (SC&OP) Processes .
Creates & analyzes input data to prepare forecast & capacity utilization reports, supply plans, and inventory reports.
Collaborates closely with business partners to optimize schedules & production plans, measure performance to plan, and help create and support mitigation plans when results are unexpected.
Interrogates and evaluates impact of changes to input variables and supply chain processes.
Prepares & presents Supply Chain status reports & analysis enabling Senior Management decision making.
Creates budgets for and track Work in Process inventory and Finished Good Inventory.
Creates and Analyzes scenarios based off production, demand, risk and investment scenarios.
Creates long range capacity, investment and make v. buy plans.
Works with internal and external stakeholders to support development and implementation of novel order-to-cash strategies and distribution models to ensure efficient order, receipt, delivery and payment keeping the needs of the patient in mind.
Establishes and maintains key relationships with Internal and/or Third Party manufacturing and logistics providers to understand product workload and ensure adequate supply and accurate inventory management for both clinical studies and commercial product.
Effectively works to develop key relationships and gain extensive knowledge of Third Party contract terms, capabilities, capacities and constraints.
Oversees with the 3rd party logistics vendor to finalize product launch strategy, post launch strategy and timelines in accordance with commercial operations and the product launch team.
Manages SPK-RPE65 secondary packaging and labeling provider
Develop, implement and oversee (or review and revise as needed) processes and procedures within areas of responsibility, such as controlled-temperature shipping (bulk drug substance, drug product and samples), receipt and chain of custody, inventory management, etc.
Manage and oversee daily logistics activities including shipping and receiving, general warehouse and materials movement within and external to Spark.
Identify and regularly report key performance indicators (such as productivity, adherence to schedule and cost controls) associated with the SC&OP process.
Create supply chain process transparency through high quality communication.
Responsible at all times for promoting a safety culture and awareness within areas of responsibility. Support and enforce the Spark EH&S policy and associated procedures.
Comfortable speaking in front of others, bringing issues to a large group of people, challenging the status quo, and conducting discussions on complex topics in an open forum.
Possess the ability to multitask and work independently or in a team environment with moderate supervision
Possess good interpersonal and strong written/verbal communication skills.
Well developed skills in prioritizing, organization and time management
Highly motivated and detail oriented with good organizational and analytical skills
Bachelor’s Degree in Supply Chain, Engineering, Computer Science or related life science field or equivalent combination of education and experience.
Minimum (10) years of related experience within the pharmaceutical/biotechnology industry is required; with a minimum of (5+) years experience in supply chain, logistics and/or operations in a GMP environment required
Must have the following experience:
Import and export of biologics, bulk drug substances, drug product and associated samples
Shipping / warehouse operations including various DOT, IATA/ICAO and Dry Ice in Transit regulations. Enterprise resource planning (ERP) modules.
Temperature-controlled solutions, such as shipping for controlled ambient, 2-8°C, and -80°C.
Project Management dealing with logistical outsourcing partners
Direct experience with import/export and state distribution licensing, a plus.
Experience or knowledge of secondary packaging and labeling for drug product and 3PL providers is a plus.
Must have excellent working knowledge of GXP compliance as well as USP, EP, ICH and FDA guidelines.
WHO WE ARE:
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
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