Senior MS&T Scientist - Sterile Drug Product

Next Generation Recruitment; Dublin; On-site; EUR 70,000 - 110,000; Full time

Job summary

Next Generation (Ireland) is seeking a Senior MS&T Scientist to lead sterile drug product technology transfer in Dublin. You’ll drive aseptic fill-finish transfers, process optimisation, and validation for biologics, collaborating with cross-functional teams to ensure successful manufacturing introductions.

The ideal candidate brings 4–8 years in MS&T or related roles, hands-on sterile manufacturing experience, and strong DoE/FMEA and cGMP knowledge to support DoE-driven investigations and risk

Qualifications

• 4-8 years in MS&T or related manufacturing role.
• Hands-on sterile drug product manufacturing or aseptic fill-finish experience.
• Proven experience supporting technology transfer, scale-up, validation, or NPI.
• Strong knowledge of aseptic processing, sterile filtration, isolator tech, and vial/syringe filling.
• Good understanding of cGMP, EU GMP, FDA regulations, and sterile manufacturing requirements.
• Familiarity with DoE, QbD, FMEA, and technical investigations.
• Strong problem-solving, technical 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, 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.

Skills

MS&T

Sterile manufacturing

Technology transfer

DoE

FMEA

cGMP

Cross-functional communication

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.