Biopharma Manufacturing Director

CONFIDENTIAL Scovai; Dublin; On-site; EUR 150,000 - 210,000; Full time

Job summary

Scovai in Dublin is seeking a Biopharma Manufacturing Director to lead a biologics or sterile manufacturing operation on-site, owning site performance and inspection readiness for HPRA, EMA and FDA audits.

You will oversee upstream/downstream or sterile fill-finish, drive Right First Time, batch release, deviation/CAPA management and technology transfer of new products, while guiding multi-shift teams and regulatory liaison.

Qualifications

• Experience leading biopharma manufacturing operations.
• Proven GMP compliance and regulatory inspection experience.
• Sterile fill-finish or biologics is a plus.
• Technology transfer and batch release experience.
• Leadership of multi-shift manufacturing teams.

Responsibilities

• Own site performance and inspection readiness end-to-end.
• Oversee upstream/downstream or sterile fill-finish operations.
• Drive Right First Time, batch release, deviations and CAPA management.
• Lead technology transfer of new products and processes into the site.
• Represent manufacturing in regulatory inspections and site reviews.

Skills

GMP Compliance

Inspection Readiness

Technology Transfer

Continuous Improvement

MES Digitalisation

Tools

MES systems

Job description

We are conducting a confidential search for a Biopharma Manufacturing Director to lead a biologics or sterile manufacturing operation for a life sciences organisation based in Dublin, working on-site. Ireland is one of the world's largest biopharma manufacturing hubs, and this is a director-level opportunity for a manufacturing leader who can own site performance and inspection readiness end-to-end.

In this role, you will own manufacturing operations across upstream/downstream processing or sterile fill-finish, ensure compliance with GMP requirements and inspection readiness for HPRA, EMA, and FDA audits, and lead technology transfer of new products and processes into the site. You will drive Right First Time performance, batch record review and release, and deviation/CAPA management, and oversee validation lifecycle for equipment, processes, and cleaning.

You will build and lead a multi-shift manufacturing organisation of managers, supervisors, and operators, partner with quality, engineering, and supply chain on site capacity and capital planning, and represent manufacturing in regulatory inspections and corporate site reviews. You will also drive continuous improvement and digitalisation initiatives to lift yield, cycle time, and right-first-time performance.

Nice to Have:

• Experience with sterile fill-finish or biologics drug substance manufacturing
• Direct experience hosting HPRA, EMA, or FDA inspections
• Background leading technology transfer into a new or existing site
• Six Sigma or Lean manufacturing certification
• Experience with manufacturing digitalisation (MES, batch record automation)