Associate Director, Logistics – Ultragenyx Pharmaceutical – Novato, CA, USA
Reporting to the Director, Supply Chain Ultragenyx is seeking a highly motivated, proactive Logistics leader with clinical and commercial logistics expertise. 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 future commercial supply, requiring in depth understanding of GDP, inventory management, Interactive Response Technology (IRT), Investigational Medicinal Product (IMP), cold chain, import/export and logistics. Position will be responsible for management of depot network, requiring negotiation, relationship management and financial oversight of contracted depots. The candidate has a demonstrated ability to expediently obtain tangible results.
Responsibilities :
- Budget owner for depots, shipping and storage; set budgets and manage variances
- Works closely with Supply Chain Planning, Quality, Manufacturing, and Packaging/Labeling team to own and manage the movement(s) of raw materials through finished goods to support production as well as shipments to end customers
- Develop shipping forecast with Clinical/Commercial Operations
- Ensure batch release dates are supportive of shipment schedule
- Select and establish incoterms, FDA product codes and HTS codes
- Create shipment documents, e.g. Proforma invoices, End Use Letters, USDA Letters, import applications and permits
- Compliance with local regulations, familiar with FDA and EMA GDP requirements as well as using the working knowledge of international trade, exporting, importing and the harmonized system
- Maintains real time awareness of external influences such as fuel costs, regulations, weather and labor issues within the pharmaceutical transportation industry
- Establish preferred shipping couriers and shipping lanes
- Assist Supply Chain team members with the following: provide supply documents required for the filing (COA, COC, QP Release, memorandums, etc.)
- Track regulatory authority changes/updates/initiatives relating to countries where shipments to clinical sites occur
- Maintain shipment database for the required documents for international shipments per specific countries
- Partner with Validation and Quality to establish shipping standards and policies
- Develop and formally document commercial and clinical shipping strategy and processes
- Assist in international depot and courier vendor selection process, obtaining RFPs, establishing competitive bids and negotiation of agreements
- Onboard and manage relationships with international depot and courier vendors, including establishing agreements, quotes, purchase orders and invoicing
- Provide support on shipment requests, and temperature excursions. Actively track shipments and obtain PODs.
- Escalate issues through couriers, brokers and Regulatory when shipments are delayed
- Raise and track shipping deviations and CAPAs in TrackWise; work to resolve recurring problems with permanent solutions
- Assist with 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
- Perform ERP transactions for shipping, PO management, internal requisitions, inventory transfers and miscellaneous transactions
- Partner with Finance to ensure VAT on shipments is planned, paid and where applicable reimbursed
Requirements:
- A Bachelor’s degree or equivalent work experience in Supply Chain or related discipline
- Minimum of 10 years of experience in supply chain management and logistics in biotech/pharmaceutical industry
- Proficient in cGMP’s and pharmaceutical industry procedures and regulations
- Expert in logistics and depot management in US, Canada, Europe, Latin & South America, and Asia Pacific
- Proficient in setting shipping terms and completing shipping documentation
- Experienced with customs and regulatory clearances and how to expedite these
- Problem-solving and decision-making skills
- Flexibility and the ability to manage change
- Strong interpersonal skills
- 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
