Contract Development and Manufacturing Manager

Berkley Group; Dublin; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Lab management

Project management

CRO coordination

Education

Master's degree

Bachelor's degree

Job description

Contract Development & Manufacturing Manager Dublin (hybrid) 12-month contract

A global biotechnology company is looking for a Contract Development & Manufacturing Manager to join its External Process Development team.

you'll manage contract testing laboratories and CROs delivering analytical work for pipeline and commercial molecules.

What you'll do:

• 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 act as escalation point for analytical issues
• Optimise timelines, budgets and priorities across a rolling project portfolio
• Support supplier evaluation and selection

What you'll bring:

• Master's and 3+ years' scientific experience, or Bachelor's and 5+ years
• Large-molecule analytical development experience (preferred)
• Experience working with CTLs / CROs - Strong cGMP, CMC and Quality knowledge

Hybrid: on site twice a month, with occasional international travel.