Biologics Tech Transfer Lead: Process Development

Arcadis; Dublin; On-site; EUR 85,000 - 110,000; Full time

Job summary

Arcadis in Ireland is seeking a Process Development professional to provide NPI and lifecycle management support for biologics drug product manufacturing within a global Process Development organization. The role may contribute to the construction of a new facility housing single-use end-to-end processes and syringe fillers.

The candidate will lead product transfer projects from initiation to regulatory approval, troubleshoot parenteral manufacturing steps, and ensure compliance with FDA, EU,

Qualifications

• Bachelor's degree in science/engineering with 4 years in manufacturing or NPI; or Master's with 2 years in related experience; or Associate's with 7 years of related experience.
• Strong technical writing skills.
• Knowledge of cGMPs and regulatory requirements.
• Problem solving ability and excellent oral and written communications skills.

Responsibilities

• Development of documentation and process design for characterization studies, engineering runs, EBR creation, validation plans, and process performance qualifications for syringe filling.
• Ensuring all process validation activities comply with policies and procedures, including safety and training.
• Ensure site meets quality requirements of customers and regulatory standards (FDA, EU & international) with understanding of CMC and technology transfer.
• Participate in cross-functional process validation teams and deliver against milestones.
• Pre-approve and post-approve process validation protocols and assessments from a quality systems perspective.
• Act as site point of contact for transfer projects for drug product teams and Global Operations.
• Assist in development of validation programs to maintain regulatory compliance and contribute to validation guidance documents.
• Collate and report relevant shipping and filter validation data.
• Assist in deviation resolution and root cause analysis.
• Contribute to product quality assessments and process flow documents.

Skills

Process Development

NPI

Regulatory knowledge

Technical writing

Education

Bachelor's degree in science/engineering

Master's degree in related field

Job description

Arcadis in Ireland is seeking a Process Development professional to provide NPI and lifecycle management support for biologics drug product manufacturing within a global Process Development organization. The role may contribute to the construction of a new facility housing single-use end-to-end processes and syringe fillers.

The candidate will lead product transfer projects from initiation to regulatory approval, troubleshoot parenteral manufacturing steps, and ensure compliance with FDA, EU,