Supply Chain Specialist – Ultragenyx Pharmaceutical – Novato, CA, USA
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities! We are located in Novato, CA, 25 miles north of San Francisco.
Position Summary
Plans, manages and performs activities related to inventory management to support clinical sites in cooperation with internal and external customers. Position will be responsible for developing and executing supply plans for all phases of clinical studies, requiring understanding of GCP, inventory management, Interactive Response Technology (IRT), Investigational Medicinal Product (IMP) and logistics. This person will report to the Sr. Manager, Supply Chain and Planning and serve as a representative on relevant project teams to ensure continuity of supply.
Responsibilities
•Manage clinical site inventories through coordination with Technical Operations and Clinical Operations to ensure adequate supply is available.
•Builds clinical study demand forecasts as input into overall material requirements planning.
•Provide input to packaging and labeling timelines, prioritization and schedule through internal Tech Ops and Quality resources.
•Escalates clinical supply risks to Sr. Manager, Supply Chain and Planning.
•Partners with Clinical Operations, Regulatory Affairs, and Quality Assurance to develop clinical supply strategy and clinical site support.
•Develop standard clinical supply documents including Supply Plans, Pharmacy Manuals and supply related forms. Comply with Standard Operating Procedures (SOPs) relating to clinical supply activities.
•Monitor drug returns and destruction and partner with Clinical Operations to design drug accountability processes.
•Assist Clinical Operations with IMP accountability during studies and final reporting at study close.
•Ensure consistency of clinical supply strategy across product lines and compliance with Ultragenyx policies and procedures and applicable regulatory authority directives and regulations.
•Maintain up to date information regarding initiatives by FDA, EMA and other applicable regulatory authorities relating to clinical supply and documentation.
•Provide clinical sites with supply documents required for their files, i.e. certificates of analysis and compliance, QP release, memorandums.
•Manage shipments, including importation/exportation compliance, of labeled supply to the appropriate drug depot CMO and subsequent shipment to the clinical sites.
•Monitor clinical cold chain shipments and resolve any temperature excursions or product inquiries, arranging for resupply, if necessary.
•Provide study specific requirements, review specifications, perform testing and utilize IRT systems to manage clinical supply.
Requirements
Requirements
•Bachelor’s Degree required.
•3+ years in a pharmaceutical environment.
•Working knowledge of GCP, pharmaceutical industry procedures and regulations.
•Flexibility and the ability to manage change.
•Strong interpersonal skills and the ability to work well as part of a team.
•Solid organizational, time management and project management skills.
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