The Associate Director, Supply Chain will be the primary liaison with third party vendors for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to commercial product.
Required Skills
LOGISTICS
- Responsible to ensure logistics to support the labeling, packaging and shipment of commercial drug substance as well as commercial drug product.
- Monitor and track shipments to ensure smooth transit through the logistical path –including international shipping.
- Maintain collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements.
- Manage inventory to ensure continuous supply and target inventories of commercial drug substance and drug product.
- Assist in the creation of Standard Operating Procedures.
- Responsible for investigation of exceptions to determine root causes and work with stakeholders to drive closure and implement corrective actions as required.
- Coordinate and track shipments. Maintain and track import licenses.
INVENTORY MANAGEMENT
- Responsible for inventory accuracy, tracking, reporting, auditing. Identify, manage and problem solve material availability issues, reduce non-value-added time spent on expediting.
- Utilize tools / systems that track, measure, analyze and control inventory levels.
- Develop, support and maintain the processes for the creation / revision of ERP master data.
- Active participant in expanding ERP system functionality.
Required Experience
Basic Qualifications:
- Bachelor’s degree with 7+ years of experience with a minimum of 2 years within a clinical and/or commercial supply chain function in a biotech or pharmaceutical environment and
OR
- Associate’s Degree with 12+ years of experience with at least 4 years in a biotech or pharmaceutical environment
OR
- 15 years of work experience within a clinical and/or commercial Supply Chain function in a biotech or pharmaceutical environment
- Prior Cold Chain distribution experience.
Preferred Qualifications:
- Working knowledge and experience with ERP and Quality systems required
- Experience in vendor oversight and managing external partnerships and relations.
- Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP).
- Experience in deviation investigation and CAPA implementation.
- Creative, capable problem-solver
- Experience in establishing and maintaining relationships with vendors
- Excellent written, verbal and interpersonal communication skills with the ability to effectively interact with internal and external teams at all levels
- A team player with a great positive and professional attitude
- Ability to manage and multi-task in a fast-pace, high-growth environment
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for patients with kidney disease. The company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com.