Senior Scientist, Sterile Drug Product Technology 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

Senior Scientist, Sterile Drug Product Technology Transfer | Biologics

Contract Duration: 12 months

Hours: 39 hours per week

Start Date: January 2027

Contract: PAYE / LTD Company Contractor

We are currently recruiting for a Senior Scientist, Sterile Drug Product Technology Transfer to join a leading global biopharmaceutical organisation at its Cruiserath manufacturing site in Dublin.

This is an excellent opportunity for an experienced MS&T / Technology Transfer Scientist with strong expertise in sterile drug product, aseptic processing and fill-finish manufacturing to support technology transfer, scale-up, validation and new product introduction activities within a biologics manufacturing environment.

Key Responsibilities

• Support the technology transfer of biologics drug products into the sterile drug product manufacturing facility
• Provide technical expertise across aseptic manufacturing, formulation, vial and syringe filling and automated visual inspection
• Support equipment preparation, sterilisation, sterile filtration and isolator-based manufacturing processes
• Support qualification of raw materials, excipients, single-use systems and primary packaging components
• Establish manufacturing process parameters across key unit operations
• Execute development studies, process characterisation, optimisation and troubleshooting
• Perform Design of Experiments (DoE) and Process Risk Assessments / FMEA
• Prepare and review technology transfer plans, study protocols, validation protocols and technical reports
• Lead and support process validation, PPQ and new product introduction activities
• Support technical investigations associated with aseptic drug product manufacturing
• Work cross-functionally with Manufacturing, Quality, Engineering, Regulatory and other technical teams
• Co-author and review relevant CMC sections of regulatory filings
• Ensure technology transfer and validation activities comply with applicable cGMP and regulatory requirements

What We’re Looking For

• Strong experience within sterile drug product / parenteral manufacturing
• Hands-on knowledge of aseptic processing and fill-finish operations
• Experience with areas such as sterile filtration, sterilisation, isolator technology, vial/syringe filling and lyophilisation
• Proven technology transfer and scale-up experience within commercial pharmaceutical or biologics manufacturing
• Experience supporting process validation and PPQ
• Strong knowledge of EU GMP and FDA regulatory requirements
• Experience with DoE, Quality by Design, FMEA and Quality Risk Management
• Ability to lead complex technical investigations and troubleshoot manufacturing processes
• Experience working with raw materials, excipients, single-use systems or primary packaging components
• Strong technical documentation and report-writing skills
• Excellent analytical, problem-solving and statistical skills
• Strong cross-functional stakeholder management and project delivery experience
• Biologics and sterile injectable manufacturing experience highly advantageous