NPI Process Development Lead – Tech Transfer & Validation

Amgen SA; Ireland; Remote; EUR 90,000 - 130,000; Full time

Job summary

Amgen is seeking a Process Development Manager to lead technical delivery of NPIs and lifecycle changes to ADL, supporting vial and syringe manufacturing. You will oversee a team of tech transfer engineers/scientists and contribute to regulatory filings while ensuring compliance with global standards.

The role requires a strong background in process development, tech transfer, and validation, with experience in sterile processing and biologics.

Qualifications

• Bachelor's degree in Science, Engineering or a relevant Quality discipline with 5 years’ experience in a similar role.
• Knowledge of cGMPs and other worldwide regulatory requirements.
• Problem solving ability and excellent oral and written communications skills

Responsibilities

• Lead tech transfers of NPIs and LCMs to ADL.
• Manage a team of tech transfer engineers/scientists.
• Provide technical support to large and small molecule drug product manufacturing.
• Develop validation plans and PPQs for vial and syringe processes.
• Ensure compliance with FDA, EU and international standards.

Skills

cGMP knowledge

Regulatory awareness

Problem solving

Communication skills

Team leadership

Education

Bachelor's degree in Science or Engineering

Master's degree

Associate's degree

PhD (preferred)

Job description

Amgen is seeking a Process Development Manager to lead technical delivery of NPIs and lifecycle changes to ADL, supporting vial and syringe manufacturing. You will oversee a team of tech transfer engineers/scientists and contribute to regulatory filings while ensuring compliance with global standards.

The role requires a strong background in process development, tech transfer, and validation, with experience in sterile processing and biologics.