Clinical Packaging Supervisor

2 weeks ago

London, Greater London, United Kingdom CHR Life Sciences Full time
CHR Life Sciences is exclusively partnered with a boutique clinical services firm looking to expand.

The company, founded in 2015, recently acquired its clinical packaging service license from the MHRA in 2023 and is looking for a supervisor to help build out the function and create a team of operators beneath them.


Job Responsibilities:

  • Ensure the quality of packaged clinical trial materials are consistent with protocol, IMPD and any other sponsor requirements.
  • Create clinical trial packaging documentation including specification, labels, blinding strategies, randomisation, batch packaging records, dispatch and returns.
  • Manage timely receipt and release of starting materials, bulk, and components.
  • Ensure IMPs, NIMPs and Comparators are received and stored according to the SOPs and the sponsor requirements.
  • Supervise clinical trial packaging operations that include directly working in clinical trial packaging operations when required.
  • Support timely completion of QP Certification of clinical trial supplies.
  • Maintain finished goods inventories and ensure timely distribution of trial materials to the clinical sites.
  • Resolves clinical trial product distribution issues by working closely with couriers, customers and clinical sites
  • To complete reconciliation and agree with the customer on product disposition, destruction and or returns at the end of the study
  • Host and manage customer visits along with the QA Teams.
  • Support assigned customer meetings, teleconferences, and internal meetings.
  • Customer point of contact for clinical packaging, storage and distribution as assigned.
  • Manage sourcing and supply of comparator products as required for the clinical trials.
  • Ensure compliance with the company's Pharmaceutical Quality Management System in accordance with the relevant SOPs and instructions.

Qualifications & Requirements:

  • Ideally a degree in Pharmaceutical Sciences, Clinical Supplies, or similar disciplines.
  • Must have 5+ years on-the-job experience in a clinical manufacturing and or packaging environment.
  • Have in-depth understanding of clinical trials and supplies.
  • Knowledge of QMS Quality standards including GMP, GCP and GDP.
  • Experience in clinical supply field and a contract manufacturing organisation

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