Senior MS&T Scientist - Sterile Drug Product

Posted 4 days 21 hours ago by Next Generation Recruitment

Permanent
Full Time
Other
Dublin, Ireland
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.