Senior Process Development Specialist

Amgen; Leinster; On-site; EUR 95,000 - 125,000; Full time

Job summary

Amgen is seeking a Senior Associate in Process Development to design, develop, and optimize manufacturing processes for parenteral products. You’ll conduct experiments, analyze results, and implement improvements to enhance efficiency and quality, guiding technology transfer and validation activities across NPI and post‑NPI phases.

Contribute to regulatory filings and responses, work as a technical expert on drug product processing, and partner with Operations, Engineering and external vendors

Qualifications

• Bachelor’s degree in Science, Engineering or quality discipline with 2–3 years in a similar role or Master’s with 2 years related experience or Associate’s with 5 years related experience.
• Knowledge of cGMPs and worldwide regulatory requirements.
• Strong problem solving and communication abilities.

Responsibilities

• Design, develop, and optimize manufacturing processes across stages of development and transfer.
• Conduct experiments, analyze data, and implement process improvements for product quality and efficiency.
• Provide process development expertise for sterile processing, tech transfer, and validation in commercial DP settings.

Skills

Problem solving

Communication

Cross-functional teamwork

Regulatory understanding

Education

Bachelor’s degree in Science, Engineering or related Quality discipline

Master’s degree in Science or Engineering

PhD in Science or Engineering

Associate’s degree with related experience

Job description

Amgen is seeking a Senior Associate in Process Development to design, develop, and optimize manufacturing processes for parenteral products. You’ll conduct experiments, analyze results, and implement improvements to enhance efficiency and quality, guiding technology transfer and validation activities across NPI and post‑NPI phases.

Contribute to regulatory filings and responses, work as a technical expert on drug product processing, and partner with Operations, Engineering and external vendors