Director, Supply Chain – 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 with a future office in Brisbane, California.
Position Summary
Reporting to the Chief Technical Operations Officer Ultragenyx is seeking a highly motivated Supply Chain leader with clinical and commercial supply management expertise. Position leads team to strategically establish and manage global supply network and associated inventories to support customers. Person collaborates with Manufacturing, Packaging and Labeling, Quality, Clinical and Commercial Operations to deliver to both internal and external customers. This individual will be responsible for developing and managing supply plans for all phases of clinical studies, expanded access/named patient programs and future commercial supply, requiring in depth understanding of GXP, planning/scheduling, inventory management, Interactive Response Technology (IRT), Investigational Medicinal Product (IMP) and logistics. Position will be responsible for development and management of depot network, requiring negotiation, relationship management and financial oversight of contracted depots. The candidate has a demonstrated ability to manage a team to expediently obtain tangible results.
Responsibilities
- Lead Supply Chain team, manage team members in their day to day work and career growth.
- Budget owner for depots, shipping and storage; set budgets and manage variances.
- Execute multi-stage inventory planning, from raw materials through finished goods in coordination with Manufacturing, Clinical Operations, Commercial Operations and Quality.
- Oversee development of clinical demand forecasts and aggregate forecasts as appropriate for input into planning model.
- Ensure batch release dates are properly prioritized for manufacturing, packaging and labeling timelines, based on need and input from Manufacturing, Regulatory and Quality.
- Develop and manage lot use strategies with Manufacturing, Regulatory and Quality; ensuring CMC changes are approved as needed to enable lot use in the targeted countries.
- Establish clear deliverables and supply strategies for Project Teams and senior management.
- Develop and formally document commercial and clinical supply strategy and processes.
- Supply Chain lead in CRO, IWRS and other clinical vendor selection processes.
- Lead international depot vendor selection process, obtaining RFPs, establishing competitive bids and negotiation of agreements.
- Onboard and manage relationships with international depot vendors, including establishing agreements, quotes, purchase orders and invoicing.
- Manage inventory reconciliation and partner with Finance for financial closes.
- Act as Supply Chain lead in the selection, set-up and management of IWRS for all clinical programs.
- Ensure team compliance to GCP documentation requirements and training.
- Establish consistency of supply strategy across product lines and compliance with Ultragenyx policies, procedures and applicable regulatory authority directives and regulations.
- Facilitate group trainings regarding initiatives by FDA, EMA and other applicable regulatory authorities relating to Supply Chain and documentation.
- Provide oversight for importation/exportation compliance of labeled supply to the appropriate drug depot and subsequent shipment to the clinical sites.
- Participate in Inspection Readiness effort, ensuring Supply Chain is fully prepared for both internal and external audits.
- Track Supply Chain deviations and CAPAs; work to resolve recurring problems with permanent solutions.
- Assist in product serialization efforts in compliance with new requirements.
- Leverage controlled room temperature and cold chain expertise to guide selection of shippers, couriers and shipping lanes.
- Utilize ERP experience to provide insight for ERP design and implementation.
Requirements
- A Master’s degree or equivalent work experience in Supply Chain or related discipline
- Management experience of 7 years or more
- Minimum of 12 years of experience supply management and logistics in biotech/pharmaceutical industry
- Proficient in cGMP’s and pharmaceutical industry procedures and regulations
- Expert in supply to and depot management in US, Canada, Europe, Latin & South America, and Asia Pacific
- Understanding of systems selection, design and management
- Problem-solving and decision-making skills
- Flexibility and the ability to manage change
- Strong interpersonal skills and the ability to lead a team
- Exceptional verbal and written communication skills, and negotiation skills
- Solid organizational, time management and project management skills
- Demonstrated ability for analytical and systematic thinking
- Experience with the following software: Microsoft Word/Excel/PowerPoint/Project, Oracle
