Senior Process Development Lead - NPI & Tech Transfer

Biopharma Careers; Dublin; Sur place; EUR 78 000 - 106 000; Plein temps

Avantages offerts par ce poste

Résumé du poste

Amgen in Ireland is seeking a Process Development Manager to lead tech transfers and lifecycle changes for parenteral products. You will coordinate validation activities, support regulatory filings, and act as a process expert for manufacturing and quality systems.

The role requires 5–10 years in pharma/biotech, strong leadership, and a track record in process development, validation, and cross-functional project delivery.

Qualifications

• Bachelor's degree in Science/Engineering with 5 years’ experience in a similar role.
• Knowledge of cGMPs and regulatory requirements.
• Strong problem solving and communication skills.

Responsabilités

• Lead tech transfers and process validation for NPIs and lifecycle changes.
• Manage a team of tech transfer engineers/scientists.
• Provide regulatory support during NPI filings and regulator Q&A.
• Develop and validate vial/syringe processes and sterile operations.
• Collaborate with Operations, Engineering and external vendors on equipment impacts.
• Lead risk assessments and CAPA for drug product operations.

Connaissances

cGMP knowledge

Problem solving

Communication

Cross-functional leadership

Project management

Formation

Bachelor’s degree in Science/Engineering

Master’s degree in Science/Engineering

Associate’s degree

Description du poste

Amgen in Ireland is seeking a Process Development Manager to lead tech transfers and lifecycle changes for parenteral products. You will coordinate validation activities, support regulatory filings, and act as a process expert for manufacturing and quality systems.

The role requires 5–10 years in pharma/biotech, strong leadership, and a track record in process development, validation, and cross-functional project delivery.