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Manager, Clinical Supply Chain Planning

Location San Rafael, California Workstyle Open to Hybrid
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

Job Title:                     Manager, Clinical Supply Chain Planning

Location:                     San Rafael

COMPANY DESCRIPTION:

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists, and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY DESCRIPTION:

Key interfaces include:

  • Product Supply Chain Owner (PSCO)
  • Network Planning
  • Clinical Operations
  • Quality Assurance
  • Production Scheduling
  • Global External Operations (GEO)
  • Enterprise Master Data Management
  • Logistics team, packaging engineering and validation

This crucial role is a member of the BioMarin Global Supply Chain and participates in Clinical Supply Chain project initiatives and efforts, including process improvement, and delivering TOPs and SCOPE strategic objectives.

Responsibilities:

  • Ensure accurate demand signals and inventory levels are incorporated into the overall supply plan for manufacturing of IP
  • Collaborate with domestic and international logistics for shipment of samples, drug product and finished goods to support clinical trials
  • Develop supply plans that support clinical program objectives and ensure uninterrupted availability of drug at global study sites. Ensure supply plans effectively incorporate manufacturing capacity and lead times.
  • Manage GMP inventory throughout the supply chain, inventory metrics, and manage shelf-life extension
  • Participate in developing supply chain management strategies to maximize supply efficiency, minimize waste, identify supply risks, and develop risk mitigation plans
  • Establish internal SOPs for supply chain management related activities
  • Work with stakeholders to develop, communicate and implement contingency plans for unplanned events
  • Prepare, forecast, and manage the production plan and ensure adherence to the approved budget
  • Develop and maintain Clinical Supply Chain SOPs/Work Instructions
  • Support continuous improvement programs and/or compliance projects that benefit or impact the clinical supply chain business process
  • Monitor and collect data on current operations, including scheduling, sourcing, warehousing, production, and delivery
  • Analyze data to determine areas for performance improvement
  • Investigate pain points within the process and develop solutions to resolve conflicts and inefficiencies
  • Lead change management process and controls for the department
  • Monitor internal and external industry trends

Must have: Minimum Requirements:

  • BS/B.Sc., preferably in the life science, engineering, supply chain or business administration
  • Materials management, production planning and scheduling experience
  • Biopharma experience, in a complex, virtual, clinical/commercial supply chain environment
  • GMP/GCP compliant pharmaceutical operations experience
  • APICS certification desirable
  • Knowledge in supply chain, planning or materials management, packaging and labeling, logistics including import/export, inventory management, and electronic systems such as IRT or ERP
  • Strong organizational, analytical, and interpersonal skills
  • Demonstrated ability to work in cross-functional teams with minimal supervision
  • Ability to prioritize and manage deadlines in a fast paced, dynamic environment with multiple projects
  • Subject-matter expertise in ERP systems, preferably Oracle or SAP
  • Ability to understand the impact of unique issues from multiple functional perspectives including Regulatory, Quality, Supply Chain, and Manufacturing to assess best options
  • Business process thinker. Drives for continuous improvement of business process to achieve product strategies.
  • Demonstrated, deep understanding of end-to-end global supply chain processes
  • Ability to work in a global, matrix organization
  • Can accommodate required international travel

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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San Rafael

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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