NPI Process Development Lead

Amgen; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Amgen in Ireland seeks a Process Development Manager who will deliver NPIs and lifecycle management for parenteral products. You will lead tech transfers and process validation with 5–10 years in pharma/biotech, and manage teams.

You will drive transfers into vial/syringe operations, support regulatory filings, CAPA, risk assessments, and collaborate with Manufacturing, QA and vendors to ensure compliant, robust processes for NPIs and post-NPI activities.

Qualifications

• Bachelor degree with 5 years’ experience in a similar role, or Master’s with 3 years, or Associate’s with 10 years.
• Knowledge of cGMP and global regulatory requirements.
• Strong problem solving, and excellent oral and written communication skills.

Responsibilities

• Lead new product introductions and lifecycle changes from a Process Development perspective.
• Manage a team of tech transfer engineers/scientists across vial/syringe transfers.
• Contribute to regulatory filings and respond to regulator questions as needed.
• Provide technical expertize for parenteral drug product processing and validation.
• Develop and transfer processes to commercial sites and support CAPA and risk assessments.
• Lead cross-site teams and collaborate with manufacturing, QA, and external vendors.

Skills

Leadership

Tech transfer

Process validation

Regulatory collaboration

Problem solving

Communication

Education

Bachelor's degree in Science, Engineering or related quality discipline

Master's degree in Science or Engineering (preferred)

PhD (preferred)

Job description

Amgen in Ireland seeks a Process Development Manager who will deliver NPIs and lifecycle management for parenteral products. You will lead tech transfers and process validation with 5–10 years in pharma/biotech, and manage teams.

You will drive transfers into vial/syringe operations, support regulatory filings, CAPA, risk assessments, and collaborate with Manufacturing, QA and vendors to ensure compliant, robust processes for NPIs and post-NPI activities.