Senior MS&T Scientist – Sterile Drug Product

Next Generation; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Next Generation in Dublin, Ireland is seeking a Senior MS&T Scientist to lead sterile drug product technology transfer and scale-up for biologics, including aseptic fill-finish, formulation, and process validation.

You will drive DoE, FMEA and PPQ activities, review CMC documentation, and collaborate with manufacturing, quality and engineering to ensure timely and compliant technology transfers to commercial production.

Qualifications

• Hands-on experience in sterile drug product manufacturing or aseptic fill-finish operations.
• Knowledge of DoE, QbD, and risk assessments.
• Strong documentation and cross-functional communication skills.

Responsibilities

• Drive sterile drug product technology transfer and scale-up activities for biologics manufacturing.
• Provide technical expertise in aseptic processing, formulation, vial and syringe filling, and fill-finish operations.
• Support process validation, PPQ, and new product introductions (NPI).
• Execute process characterisation, optimisation studies, and technical investigations.
• Lead DoE and FMEA assessments and risk evaluations.
• Support qualification of raw materials, single-use systems, and primary packaging components.
• Prepare and review technology transfer protocols, validation reports, and CMC documentation.
• Collaborate with cross-functional teams to ensure successful manufacturing transfers.

Skills

Sterile transfer

Aseptic fill-finish

Process validation

DoE

QbD

cGMP

Cross-functional

Job description

Senior MS&T Scientist – Sterile Drug Product

Location: Dublin, Ireland

The Opportunity

Take the lead in sterile drug product technology transfer and help bring biologics products into commercial manufacturing.

We're seeking an experienced Senior Scientist to support high-impact MS&T projects, from aseptic fill-finish and process optimisation to validation and new product introductions at a leading biopharmaceutical manufacturing facility.

Key Responsibilities

• Drive sterile drug product technology transfer and scale-up activities for biologics manufacturing.
• Provide technical expertise in aseptic processing, formulation, vial and syringe filling, and fill-finish operations.
• Support process validation, Process Performance Qualification (PPQ), and new product introductions (NPI).
• Execute process characterisation, optimisation, development studies, and technical investigations.
• Lead technical troubleshooting and risk assessments, including DoE and FMEA.
• Support qualification of raw materials, single-use systems, and primary packaging components.
• Prepare and review technology transfer protocols, validation reports, and CMC documentation.
• Collaborate with cross-functional teams to ensure successful manufacturing transfers.

Qualifications & Experience

• 4–8 years of experience in Manufacturing Science & Technology (MS&T), sterile drug product technology transfer, or a closely related technical manufacturing role within the pharmaceutical or biopharmaceutical industry.
• Hands-on experience in sterile drug product manufacturing or aseptic fill-finish operations is essential.
• Proven experience supporting technology transfer, process scale-up, validation, or new product introductions.
• Strong technical knowledge of aseptic processing, sterile filtration, isolator technology, and vial/syringe filling.
• Good understanding of cGMP, EU GMP, FDA regulations, and sterile manufacturing requirements.
• Familiarity with Design of Experiments (DoE), Quality by Design (QbD), FMEA, and technical investigations.
• Strong problem-solving, technical documentation, and cross-functional communication skills.