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Manager, Clinical Supply Chain

Location Cork, Ireland
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

The Clinical Supply Chain Manager is responsible for supporting clinical studies with appropriate drug product supply, including translating clinical study information into a demand plan, managing clinical trial material supply from depots to the sites, and maintaining required essential documents.  This role serves as the Logistics lead for the Clinical Supply Chain team.

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 individuals build and maintain BioMarin’s cuttingedge 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.

Responsibilities.

  • Lead the Logistics set up activities for clinical programs across the portfolio
  • Serve as specialist for clinical transportation, cold chain logistics, and GDP oversight
  • Establish clinical study assumptions with CLO, develop associated monthly forecast and demand, load forecast into application/tool, conduct formal demand handover effectively communicating changes and assumptions
  • Own, develop, manage, and communicate IP Supply Plan for each study
  • Own, develop, manage, and communicate CSC Ancillary Plan for each study
  • Own, develop, and manage Clinical Supply Project Plan for study/country set up; oversee coordination and tracking of cross functional activities to ship/supply in time
  • Collaborate with Global Trade & Transport and Regulatory to obtain required import documentation for IP and ancillaries
  • Lead weekly/biweekly clinical study supply meetings with stakeholders
  • Lead, conduct, and document risk assessments and supply issue root cause analyses. Communicate/action lessons learned. May own
  • Establish user requirements for IXRS clinical supply/order management related modules.  Participate in IXRS set up activities, including user acceptance testing (UAT).
  • Author Pharmacy Manual sections as per template, ensuring alignment with product specification and any other applicable source documents
  • Track budget and contracts/SOWs/POs; approve invoices and perform periodic auditing (may direct CSC Associate to perform this)
  • Represent CSC at GCP inspection/audits. Maintain ongoing inspection readiness by overseeing CSC Associate tasks around IP reconciliation, eTMF uploads, and other study close out activities (incl. coordination of IP return/destruction)
  • Mentor/train CSC Associate on order management and site resupply. Assist CSC Associate in prioritizing TE inquiries based on study Oversee TE process through close out with the site.
  • Other duties as assigned
Education/Experience
  • Superior customer service ethic and interpersonal skills
  • Excellent organizational, multitasking and time management skills and ability to perform gracefully under pressure and meet inflexible or shifting deadlines
  • Positive, solution-oriented approach to problems
  • Availability to perform as part of a team as well as individually
  • Possess a working understanding of Cold Chain Shipping Solutions, Distribution Management, Good Distribution Practices, Transportation Operations, and business analysis related to these functional areas
  • Minimum of 8 years of experience in a Clinical Supply Chain / Contract Manufacturing operation in the pharmaceutical or biotech industry and 1 year of experience in a GMP environment preferred
  • Strong interpersonal skills and awareness of the Emotional Quotient in a corporate environment are required to allow the incumbent to interact and resolve conflicts with many levels inside and outside of the Supply Chain Logistics organization internationally
  • Development of project candidates based on organizational needs and goals for Continuous Improvement and Business Technology projects
  • Preferred experience in project management
  • Has a Bachelor’s degree from an accredited college or university

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.

About our location

Cork

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