Akcea Therapeutics, Inc. is a development and commercialization company focused on impacting the lives of patients with serious cardiometabolic lipid disorders. Our priority is to bring important new therapeutics to patients in need. In order to do so, we
must drive clinical program execution, understand patient and physician needs and work with regulators, payers, health care providers and patients to ensure the therapies reach and help those in need.
Established as a wholly-owned subsidiary of Ionis Pharmaceuticals, Inc. in late 2014 and based in Cambridge, Massachusetts, Akcea was founded with a robust portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense
HEAD OF SUPPLY CHAIN
The Head of Supply Chain will be responsible for, in conjunction with the expert team at Ionis, developing and leading the full, integrated supply chain for volanesorsen and the other products in Akcea’s pipeline. This individual will be accountable for
the on-time delivery of cGMP compliant clinical and commercial supplies to patients around the world. The initial focus of the role will be on ensuring that the volanesorsen supply chain is ready to support launch, with a focus on the delivery of product
to end customers.
- Provides materials management and supply chain leadership to support the build out, scale up and operation of the company's manufacturing and supply processes, including supporting global growth in new countries/regions
- Oversees and manages the supply chain operations staff, budget, and processes to deliver high quality, regulatory compliant products to patients
- Establishes and manages supply agreements with key vendors/CMO’s to mitigate manufacturing and supply risks
- Works closely with the manufacturing teams and technical experts at Ionis to support tech transfers, address regulatory questions, and provide support to the vendors to ensure high quality, on time delivery of products
- Ensures inventory projections are managed, in conjunction with commercial teams, to provide appropriate levels of inventory and resupply for all commercial and clinical products through designing and implementing an appropriate sales and operations planning
- Establishes supplier relationships and service agreements with cost effective distribution leaders to ensure successful delivery of company products to patients worldwide
- Proactively manages risks/capability and develops mitigation plans; identifies and communicates risks and issues that impact quality, compliance, project timelines, resource requirements, finances or the overall business relationship to senior management
- Manages contract items from negotiation to termination; defines and ensures supply level agreements are set and achieved
- Measures performance of CMOs through implementation and trending of key performance indicators and generates improvements plans as needed
- Establishes distribution channels in major markets, evaluating various options and vendors (e.g. 3PLs, warehousing, cold chain, etc.)
- Works closely with clinical teams to establish and implement procedures for strategic production planning to ensure adequate supply
- Works collaboratively and transparently with all functions, including process development, regulatory, quality and other key areas to ensure a high-quality level of cGMP supplies are produced with manufacturing excellence
- Collaborates with finance and commercial to ensure that data and inventory management processes support business requirements
- Additional areas of responsibility and engagement are inventory management; forecasting, demand planning, materials management, inventory deployment, supply chain systems and processes, package engineering, graphics management, change control, and labeling
- Find innovative solutions to supply chain issues
- Ensure uninterrupted supply of product to patients
- 12+ years of supply chain experience, including experience with inventory management, forecasting, import/export, materials management, and supply chain systems and processes
- In depth knowledge of global supply chains, including systems and processes
- Knowledge of cGMP, contracts and supply agreements, and quality systems and requirements as it relates to contract manufacturing organizations
- Demonstrated success in launching new products globally
- Full understanding of complex technical issues and manufacturing and prior experience with oligonucleotide manufacturing a plus.
- Experience in orphan/rare diseases is a plus
- BS / BA in engineering, manufacturing, or science related field
- Graduate degree (MBA) and / or equivalent experience and education preferred
- Resourceful and creative problem solver who will ‘roll up his/her sleeves’ to get the job done
- Strong leadership, communication and presentation skills and business partnering ability
- Strategic, analytical and results-driven thinker with the ability to plan and direct
- Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environment
- Expert drug, clinical and technical regulatory and problem solving skills
- Strong interpersonal skills and ability to work with others in a positive, collaborative manner
- Ability to travel (~10%)
Excellent salary and benefits package offered.
Please visit our website, www.akceatx.com, to apply for this position. Reference Requisition #16-0106
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and Akcea Therapeutics, Inc. are proud to be EEO employers.