Contract Development & Manufacturing Lead - Hybrid, Dublin

Berkley Group; Dublin; Hybrid; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Berkley Group in Dublin is seeking a Contract Development & Manufacturing Manager for a 12-month hybrid role to lead external process development activities and manage contractual testing labs.

You will oversee CRO relationships, coordinate method qualification and transfer, and ensure quality, cost and timely delivery across a rolling project portfolio. Hybrid: on-site twice a month with international travel.

Qualifikationen

• Master's degree or Bachelor’s with corresponding years of experience.
• Experience coordinating external labs and CROs in CDM/CMC.
• Strong knowledge of cGMP, quality systems and analytical testing.

Aufgaben

• Manage relationships and performance metrics for external testing labs.
• Project-manage analytical work packages: method qualification and transfer, release, stability and characterisation testing.
• Own quality, cost and delivery, and escalate analytical issues.
• Optimise timelines, budgets and priorities across a rolling project portfolio.
• Support supplier evaluation and selection.

Kenntnisse

Lab management

Project management

CRO coordination

Ausbildung

Master's degree

Bachelor's degree

Jobbeschreibung

Berkley Group in Dublin is seeking a Contract Development & Manufacturing Manager for a 12-month hybrid role to lead external process development activities and manage contractual testing labs.

You will oversee CRO relationships, coordinate method qualification and transfer, and ensure quality, cost and timely delivery across a rolling project portfolio. Hybrid: on-site twice a month with international travel.