Senior Scientist, Sterile Biologics Tech Transfer

Atrium; Dublin; On-site; EUR 75,000 - 105,000; Full time

Job summary

Atrium in Dublin seeks a Senior Scientist, Sterile Drug Product Technology Transfer to join our biologics manufacturing team. You will drive technology transfer, scale-up and process validation across sterile drug product operations in a biologics environment.

The role requires deep expertise in aseptic processing, fill-finish, DoE and risk management, with strong regulatory knowledge and proven cross-functional collaboration capabilities.

Qualifications

• Extensive experience in sterile drug product manufacturing.
• Proven capability in technology transfer and scale-up.
• Experience with DoE, QbD, FMEA and risk assessment.
• Strong regulatory knowledge: EU GMP and FDA.
• Excellent documentation and problem-solving skills.

Responsibilities

• Lead technology transfer of biologics sterile drug products.
• Support aseptic processing, fill-finish operations.
• Lead DoE studies and risk assessments.
• Prepare validation protocols and technical reports.
• Coordinate cross-functional teams including QA, Regulatory, Engineering.
• Ensure cGMP compliance and regulatory filings input.

Skills

Sterile drug product

Aseptic processing

Fill-finish operations

Technology transfer

Process validation

DoE

Quality by Design

FMEA

Regulatory knowledge

Documentation skills

Job description

Atrium in Dublin seeks a Senior Scientist, Sterile Drug Product Technology Transfer to join our biologics manufacturing team. You will drive technology transfer, scale-up and process validation across sterile drug product operations in a biologics environment.

The role requires deep expertise in aseptic processing, fill-finish, DoE and risk management, with strong regulatory knowledge and proven cross-functional collaboration capabilities.