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CMO Specialist

Location: Dublin South, Dublin
Salary: Negotiable
Posted: 10 months ago
Role type: Permanent
Industry: Science, Technology and Operations Practice (STO)
Contact name: Maeve Fahey
Contact email: maeve.fahey@hrmrecruit.com

Job description

Our client, a global biopharmaceutical leader, are seeking a driven Work Cell Specialist to provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure work cell/CMO success.

If you have a background in Quality, Tech Services, Tech Ops, MS&T, Process Development, or Manufacturing Science and have an interest in leading an innovative and data-driven continuous improvement project, this could be a good fit for you.

The Role

Manufacturing Operations:

  • Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting
  • Inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) et
  • Own NC Class II/III records, CAPA, CAPA EV, and more complex change control record

Project Management & Tech Transfers:

  • Follow-up and track activities in a department-wide project from conception to implementation and close-out
  • Manage timeline and highlight risks of transfer team activities
  • Coordinate risk management activities as part of transfer

Site Performance Monitoring:

  • Report contract site performance metrics to site lead
  • Identify improvement opportunities for site performance.
  • Conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by relevant teams.
  • Active participation in team meetings with the contract site as well as internal site team.

The Person

You will have skills and experience in the following:

  • Minimum BSc in Science or Engineering related discipline.
  • 5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment.
  • 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles.
  • Project management experience leading multi-functional and/or multi-location team.
  • Demonstrated negotiation skills.
  • Operational Excellence proficiency and ability to drive continuous improvement.
  • Financial/budgeting knowledge and business acumen.
  • Proficient project management skills.
  • Demonstrated ability to lead effectively in collaborative/team environment.

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.

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Maeve Fahey

Science Recruitment Consultant

Current assignments