Scientist, Manufacturing Technology

Atrium; Dublin; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

Atrium seeks an experienced Scientist, Manufacturing Technology to support sterile drug product technology transfer activities within a leading biopharmaceutical manufacturing environment.

This position will work within Manufacturing Science & Technology (MS&T), supporting the successful transfer, scale-up and validation of biologic parenteral manufacturing processes.

Competenze

• Experience in sterile/parenteral pharmaceutical or biopharmaceutical manufacturing.
• Strong hands-on knowledge of aseptic processing and fill-finish operations.
• Experience with sterilisation, sterile filtration, isolator technology and/or lyophilisation.
• Experience delivering technology transfer and scale-up projects for commercial drug product processes.
• Knowledge of EU GMP and FDA requirements.
• Experience with process validation, PPQ, DoE, QbD and/or Quality Risk Management.
• Strong technical troubleshooting and investigation experience within an aseptic manufacturing environment.
• Excellent cross-functional communication and problem-solving skills.

Mansioni

• Support technology transfer and scale-up of biologic sterile drug product manufacturing processes.
• Provide technical expertise across aseptic processing, formulation, vial and syringe filling, sterile filtration and fill-finish operations.
• Support process development, optimisation, troubleshooting and product characterisation activities.
• Prepare and review technology transfer plans, validation protocols, technical reports and SOPs.
• Support PPQ, process validation and new product introduction activities.
• Perform or contribute to DoE, FMEA and process risk assessments.
• Support qualification of raw materials, excipients, single-use systems and primary packaging components.
• Work cross-functionally across Manufacturing, Quality, Engineering and other technical teams.
• Contribute to CMC documentation and regulatory submissions.

Descrizione del lavoro

Atrium is seeking an experienced Scientist, Manufacturing Technology to support sterile drug product technology transfer activities within a leading biopharmaceutical manufacturing environment.

This position will work within Manufacturing Science & Technology (MS&T), supporting the successful transfer, scale-up and validation of biologic parenteral manufacturing processes.

Key Responsibilities

• Support technology transfer and scale-up of biologic sterile drug product manufacturing processes.
• Provide technical expertise across aseptic processing, formulation, vial and syringe filling, sterile filtration and fill-finish operations.
• Support process development, optimisation, troubleshooting and product characterisation activities.
• Prepare and review technology transfer plans, validation protocols, technical reports and SOPs.
• Support PPQ, process validation and new product introduction activities.
• Perform or contribute to Design of Experiments (DoE), FMEA and process risk assessments.
• Support qualification of raw materials, excipients, single-use systems and primary packaging components.
• Work cross-functionally across Manufacturing, Quality, Engineering and other technical teams.
• Contribute to CMC documentation and regulatory submissions.

We are particularly interested in candidates with:

• Experience within sterile/parenteral pharmaceutical or biopharmaceutical manufacturing.
• Strong hands‑on knowledge of aseptic processing and fill‑finish operations.
• Experience with sterilisation, sterile filtration, isolator technology and/or lyophilisation.
• Experience delivering technology transfer and scale‑up projects for commercial drug product processes.
• Knowledge of EU GMP and FDA requirements.
• Experience with process validation, PPQ, DoE, QbD and/or Quality Risk Management.
• Strong technical troubleshooting and investigation experience within an aseptic manufacturing environment.
• Excellent cross‑functional communication and problem‑solving skills.