Manager, Supply Chain
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 headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco. This position can be located in Novato or Brisbane.
Position establishes, manages and performs multi-level inventory strategies to support customer and manufacturing sites in cooperation with internal and external partners. This individual will assist to ensure we are in compliance with customs and trade globally for shipments for all phases of clinical and commercial supply. The role requires an in depth understanding of GXP, planning/scheduling, inventory management, Interactive Response Technology (IRT) design, clinical and commercial logistics expertise, cold chain, import/export, and trade and compliance. Position strategically establishes and manages global depot and logistics network to support customers. This individual will be responsible for logistics for all phases of clinical studies, expanded access/named patient programs and commercial supply. This will also require negotiation, relationship management and financial oversight of contract organizations. The candidate has a demonstrated ability to work independently and expediently obtain tangible results.
Responsibilities, including but not limited to:
- Logistics reporting with the internal and external partners.
- Assist in compliance with customs and trade requirements globally for shipments.
- Select and establish INCO terms, FDA product codes and HTS code.
- Develop shipping forecast with Clinical/Commercial Operations.
- Ensure batch release dates are supportive of shipment schedule.
- 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 the required documents for international shipments per specific countries.
- Establish clear communication and tracking of strategies and scenarios for Project Teams and senior management.
- Lead necessary vendor selection process, obtaining RFPs, establishing competitive bids and negotiation of agreements.
- Onboard and manage relationships with contract organizations, including establishing agreements, quotes, purchase orders and invoicing.
- Assist Finance with inventory reconciliation and financial close.
- Establish consistency of commercial & clinical supply strategy across product lines and compliance with Ultragenyx policies, procedures and applicable regulatory authority directives and regulations.
- Support Supply Chain Specialists shipments, including importation/exportation compliance of labeled supply to the appropriate drug depot and subsequent shipment to the clinical sites.
- Track all shipment issues (damage, temperature excursions, non-compliance, etc.) and work to resolve recurring problems with permanent solutions.
- A Bachelor’s degree required, BS preferred
- Minimum of 8 years of experience in supply chain, planning or clinical supply management in biotech/pharmaceutical industry
- Working 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
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.