Logistics Specialist
An opportunity has arisen for an Logistics Professional to join a multinational pharmaceutical and biopharmaceutical company.
Location: Cambridge – Remote working for the foreseeable then 50/50 split
Pay rate: £195 PAYE - £254 LTD / Umbrella
Duration: 12 months
Role Summary:
• Independently plan and manage Drug Substance (DS), Drug Product (DP), and Investigational Medicinal Product (IMP) distribution & returns for assigned clinical studies.
• Effectively utilize Distribution tools, procedures and best practices to deliver optimal shipping solutions.
• Selection and management of distribution vendors in conjunction with Technical Manager and internal stakeholders.
• Liaise closely with distribution vendors to ensure accuracy of information transfer and creation/maintenance/tracking of accurate distribution plans, import/export documents, permits etc.
• Work collaboratively within Logistics and Clinical Supply (LCS), with external vendors, and with all other interfaces and stakeholders as required to ensure highly effective clinical product distribution
• Maintain & expand close cross-functional relationships using information pertaining to clinical studies to best design, plan and implement aligned distribution activities.
• Liaise closely with Quality Assurance (QA) to coordinate activities relating to clinical distribution and ensure execution in compliance with cGMP, GDP, GCP, & ICH guidelines
• Partner with stakeholder departments to identify critical challenges and risks associated with DS, DP or IMP distribution. Communicate and provide input into risk management plans including options and recommendation for risk mitigation
• Initiate non-conformances when identified and complete investigations to support on-time closure of deviation records
• Apply import/export intelligence and depot knowledge to develop distribution strategies appropriate to highly effective clinical product supply
• Contribute to the operational effectiveness of LCS
Experience/ Qualifications Required:
• Requires a Bachelor’s degree in basic / applied science or engineering. Equivalent level of training in service may also be considered.
• Experience in the Biotechnology and/or Pharmaceutical industry (including experience in distribution of pharmaceutical materials) is required.
• Specific experience in IMP management and /or distribution is desirable.
• Working understanding of import/export regulations, global distribution regulations and dangerous goods regulations in distributing medicinal supplies including IMP, AMP, devices and instruments used in the medical field
• A good understanding of cGMP, GCP and GDP environment and applicable Regulations and Guidance as relates to IMP distribution.
• Preferably will have a sound understanding of the drug development process and ideally also demonstrable success in delivery of cross-functional projects and/or activities.