Global NPI Project Lead – Biopharma Product Introductions

Tandem Project Management Ltd.

Dublin

On-site

EUR 90,000 - 120,000

Full time

3 days ago

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Job summary

Tandem Project Management Ltd. is assisting a global biopharmaceutical company based in Dublin in recruiting an NPI Project Manager.

The role covers project management and coordination for introducing new products within Bulk Drug Substance Manufacturing, overseeing scope, budgets, and scheduling to support technology transfer from a receiving site. You will coordinate multidisciplinary teams across Operations, Technical Services, Engineering, Validation, Automation, QC and QA to meet

Qualifications

Degree or Master’s in a science or engineering discipline, or vocational qualification in NPI.
Minimum of 5 years’ experience in pharmaceutical manufacturing (bulk drug substance biologics preferred).
Minimum of 3 years’ Project Management experience leading cross-functional teams in pharma.
Experience in Technology Transfer and/or New Product Introduction projects.
Working knowledge of regulatory requirements for pharma.
Operational Excellence experience preferred.
Application of AI tools preferred.
Lean or Six Sigma tools advantageous.

Responsibilities

End-to-end PM and coordination of site activities for introducing new products, from feasibility to manufacture, regulatory filing and approval.
Create and maintain a standardised work breakdown structure and project schedules for technical transfer and readiness from a receiving unit perspective.
Support CMC sub-teams and Supply Chain NPI/Launch teams with progress updates, risks and mitigation plans.
Provide direction to the internal NPI project team across disciplines to execute site activities.
Plan and execute Technology Transfer projects, including resource needs and options analysis.
Develop project controls: plan, schedule, risks and cost to align timelines and budgets.
Communicate progress regularly and prepare dashboards on performance and costs.
Ensure policies and procedures are followed during construction and start-up activities.
Support the technical team with PM reports, schedules and plans.
Organise and facilitate project meetings and Stage-Gate reviews with NPI Lead and CMC sub-teams.