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WEP Clinical

Specialist services for early access medicines

cGMP Production Manager

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeDublin, IrelandNo salary listedIn-person

About the Job

Requirements

  • At least five years of experience in cGMP secondary packaging and labeling operations within the pharmaceutical or clinical supply chain environment, preferably supporting clinical trial materials.
  • Strong working knowledge of cGMP requirements and global regulatory standards governing pharmaceutical packaging and labeling.
  • Demonstrated expertise in label design, artwork development and proofing, master batch record management, and packaging documentation, including rigorous version control and attention to detail.
  • Hands-on experience using enterprise resource planning systems to support production scheduling, Bill of Materials management, and operational workflow optimization.
  • Ability to think strategically, solve complex operational challenges, and collaborate with cross-functional partners, including Project Management, Regulatory Affairs, Quality Assurance, Procurement, and external suppliers.
  • Strong vendor and stakeholder management capabilities, with a consistent focus on compliance, accuracy, and on-time delivery.
  • Experience supporting and coordinating client and regulatory audits related to packaging and labeling activities.

Responsibilities

  • Execute and oversee good manufacturing practice production activities, including room setup, batch execution, in-process checks, reconciliation, line clearance, and clean-down.
  • Maintain production suites in a continuous audit-ready state, ensuring compliance with good manufacturing practice, good documentation practice, standard operating procedures, and quality standards.
  • Serve as a global production subject matter expert, providing real-time troubleshooting, escalation support, and technical guidance during operations.
  • Verify readiness and compliance of materials, labels, packaging components, equipment, and documentation prior to batch execution.
  • Create, review, and maintain master batch records and electronic batch records, ensuring accurate, timely, and compliant batch documentation.
  • Develop, proof, issue, control, and reconcile label templates, artwork, and packaging layouts to meet regulatory, client, and protocol requirements.
  • Partner with Project Management, Regulatory, and Quality to finalize packaging and labeling designs, layout drawings, samples, and client approvals.
  • Maintain Bills of Materials and related master data in enterprise resource planning systems, ensuring accurate configuration, versioning, and updates.
  • Support vendor coordination, sourcing decisions, and supplier qualification for packaging components, tooling, consumables, and equipment.
  • Drive process optimization, change controls, system enhancements, and global standardization initiatives across Production and Global Supply Chain Operations.

About the Company

WEP Clinical

Specialist services for early access medicines

WEP Clinical provides access to unlicensed or scarce medicines through Expanded Access Programs (EAP) and Managed Access Programs (MAP) for healthcare providers in 60+ countries. It designs and runs these programs, coordinates with manufacturers and regulators, and sources medicines via a global network, with import authorizations and logistics handled by country managers and in-house pharmacists. Its approach combines global sourcing with local expertise and an end-to-end program model, differentiating it from others that rely on limited markets or suppliers. Its goal is to deliver needed treatments quickly when options are unavailable.

Company size
201-500
Company stage
Not listed
Total funding
Not listed
Headquarters
London, United Kingdom
Founded
2008

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