Manufacturing Operations Manager

4 weeks ago


Richmond, Virginia, United States Global Recruiters of Dublin (GRN Dublin) Full time
Job Summary

We are seeking a highly skilled Manufacturing Specialist- Line Lead to join our team at Global Recruiters of Dublin (GRN Dublin). The ideal candidate will have a strong background in biopharmaceutical manufacturing, with experience in leading daily manufacturing activities and collaborating with cross-functional teams.

Key Responsibilities
  • Lead daily manufacturing activities on the floor, aligning and scheduling personnel and resources to meet production and equipment demands.
  • Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety, and other cross-functional teams to meet production needs.
  • Support the onboarding and technical training of Manufacturing Operators on process equipment, including high-speed fill lines with integrated Isolators, Terminal Sterilizers, ATEC commodities processing, Parts Washers, Autoclaves, Single-Use Technology, and Aseptic Process Simulations (media fills).
  • Assist R&D and MSAT on new product introduction and tech transfer activities to ensure a steady stream of products to meet commercial demand.
  • Initiate and complete manufacturing investigations, including root cause analysis and product impact assessment.
  • Assist in the revision and management of manufacturing documents such as Batch Records and SOPs.
  • Provide technical expertise and support to production teams, addressing issues and challenges as they arise while working closely with Engineering and other support teams.
  • Supports regulatory inspections.
  • Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions to minimize impact on operations.
Requirements
  • A minimum of four+ years' experience in biopharmaceutical manufacturing in a GMP environment.
  • Experience with sterile fill-finish manufacturing.
  • Knowledge of GMP, regulatory requirements, and industry best practices.
  • Detailed-oriented with a focus on accuracy in creating and updating production documents.
  • Ability to work autonomously and within established guidelines, procedures, and practices.
  • Experience in a process improvement environment, including change management.
  • Experience in using ERP systems.
  • Strong communication and collaboration skills, committed to meeting high-quality standards.
  • Experience performing as a shift lead of a team, training others, and developing training material.
Preferred Qualifications
  • Knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
  • Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
  • Proficiency in Microsoft Office Suite.


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