BridgeBio

VP, Supply Chain

BridgeBio

full-time

Posted on:

Origin:  • 🇺🇸 United States • California

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Salary

💰 $300,000 - $345,000 per year

Job Level

Lead

Tech Stack

ERPGoogle Cloud PlatformSpring

About the role

  • Manage a global team of supply chain professionals responsible for clinical and commercial end-to-end supply chain
  • Manage all aspects of commercial supply chain, including Drug Substance and Drug Product CMOs, Packaging and Labeling with CPOs, and Finished Good receiving, storage and distribution at 3PLs
  • Coordinate logistics of material transfer for clinical and commercial drug substance, drug product and components to/from international CMOs/CPOs, managing exportation, applicable USDA/FDA licenses and permits, VAT recovery and customs brokers
  • Own the global Sales & Operations Planning (S&OP) process for all commercial products, coordinating demand planning, finance and communicating final supply plans to global partners
  • Own and actively manage the commercial supply plan, commercial inventory (in process and finished goods), shelf life and expiration management
  • Own and manage all serialization activities for commercial products globally
  • Manage clinical packaging and labeling activities including label design, translation, production, distribution and inventory management
  • Provide clinical demand signals and translate total demand into a forecast based on clinical protocols or study overviews
  • Prepare clinical supply plans including determination of supply overage amounts; monitor inventory and provide regular inventory updates to project teams
  • Monitor clinical drug expiry/retest dating; initiate inventory release and re-supply; serve as the unblinded inventory manager
  • Manage domestic and international distribution and logistics for clinical programs, including importing/exporting clinical supplies and developing distribution instructions with clinical supply vendors
  • Support budget activities, including managing supplier contracts, PO generation and invoicing approvals for clinical and commercial purchases
  • Work collaboratively with QA to manage batch release, final release, temperature excursions and support investigations of deviations
  • Liaise with CMC and clinical operations and evaluate new CMOs/CPOs for commercial supply chain
  • Work with Global Trade & Distribution and global Finance teams to manage global 3PLs, ensuring finished good inventory management, distribution, logistics, sales and revenue reporting
  • Generate and maintain global SOPs in Veeva QMS and ensure compliance with industry standards
  • Develop and maintain strong cross-functional collaboration with CMC, Clinical Operations, Market Access, Finance, Quality, and Regulatory Affairs

Requirements

  • At least fifteen (15) years of experience in Supply Chain Management and/or Manufacturing functions in the pharmaceutical and/or biotechnology industries
  • Bachelor’s or Master’s Degree in a scientific discipline
  • Detailed understanding of the pharmaceutical business, including both clinical development and manufacturing and commercial manufacturing and supply chain
  • Proven experience with forecasting, demand/supply planning, inventory management, packaging, labeling and distribution including cold chain, import/export and reverse logistics
  • Proven experience managing and developing a team of professionals
  • Experience with SAP or similar ERP platform
  • Experience with product serialization, TraceLink or other similar platform and DSCSA standards
  • Experience with Veeva, or other similar QMS platform
  • Experience with clinical blinding practices
  • Experience in assisting set-up of IRT Systems for global clinical studies
  • Demonstrated skills in project management and vendor management
  • Working knowledge of drug development process (Phase I-IV)
  • Working knowledge of current GMP/GCP/GDP guidance and regulations
  • Familiar with US and EU import/export regulations
  • Excellent attention to detail, strong data analysis, problem solving and decision-making ability
  • Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders
  • Ability to handle multiple projects simultaneously
  • APICS certification or supply chain education preferred
  • Position may require occasional evening and/or weekend commitment
  • Position may require occasional travel (up to 20%), domestic and international