Manager / Senior Manager, Supply Chain – Ultragenyx Pharmaceutical – Novato, CA, US
Position Summary:ultrainnovative – Tackle rare and dynamic challenges
The Manager / Senior Manager, Supply Chain establishes, manages and performs multi-level inventory & logistics strategies to support customer and manufacturing sites in cooperation with internal and external partners. This individual will assist to ensure we comply with global trade compliance for shipments for all phases of clinical and commercial supply. The role requires an in depth understanding of GXP, planning/scheduling, inventory management, clinical and commercial logistics, cold chain, import/export, and trade compliance. Position strategically establishes and manages global depot and logistics network to support North American customers. This individual will be responsible for logistics for all phases of clinical studies, expanded access/named patient programs and commercial supply for the North American Region. This will also require negotiation, vendor relationship management and financial oversight of contract organizations. The candidate has a demonstrated ability to work independently and expediently to obtain tangible results.
Responsibilities, including but not limited to:
- Create/Support shipments, including all necessary importation/exportation documentation for product, intermediates, & WIP shipments to the appropriate site.
- Assist in compliance strategy associated with global trade requirements.
- Select and establish INCO terms, FDA product codes and HTS codes.
- Develop shipping forecast with Clinical/Commercial Operations.
- Assign and prioritize release dates for manufacturing, packaging and labeling timelines, based on need and input from Manufacturing, Regulatory and Quality.
- Create shipment documents, e.g. Proforma invoices, End Use Letters, USDA Letters, import applications and permits.
- Maintain shipment database for all required documents.
- Manage & monitor Commercial Finished Goods shipments out of the 3PL.
- Create and maintain metric dashboards tracking channel performance including inventory levels and OTIF performance.
- Support the North America Commercial Forecasting process in support of the Regional S&OP.
- Pro-actively run situational analysis and build scenarios to address specific demand and supply constraints.
- Assist Finance with inventory reconciliation and financial close.
- Manage and/or create vendor metrics to monitor performance.
- Track all shipment issues (damage, temperature excursions, non-compliance, etc.) and work to resolve recurring problems with permanent solutions.
- Lead necessary vendor selection process, creating RFPs, establishing competitive bids and negotiation of agreements.
- Onboard and manage relationships with contract organizations, including establishing agreements, quotes, purchase orders and invoicing.
- Establish consistency of commercial & clinical supply strategy across product lines and compliance with Ultragenyx policies, procedures and applicable regulatory authority directives and regulations.
- A Bachelor’s degree required, BS preferred
- Minimum of 8 years of experience in supply chain, planning or commercial / clinical supply management in biotech/pharmaceutical industry
- Extensive knowledge of cGXP’s and pharmaceutical industry procedures and regulations
- Problem-solving and decision-making skills
- Flexibility and the ability to manage change
- Strong interpersonal skills and the ability to work well as part of 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
- Proficient in use of formulas, pivot tables, charts in Excel
- Available for off-hours questions and calls for international sites
- Supply Chain or Inventory Management certifications preferred
- Travel – 15%