Biopharma Manufacturing Director: Sterile & Biologics Ops Lead

Scovai; Dublin; Vor Ort; EUR 150.000 - 210.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GMP Compliance

Inspection Readiness

Technology Transfer

Continuous Improvement

MES Digitalisation

Tools

MES systems

Jobbeschreibung

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.