Location
Galway — on-site (R&D/development laboratory)
Role Overview
The successful candidate will carry out hands-on laboratory development work, supporting formulation and/or analytical method development, stability programmes, and technical documentation to progress products through the development lifecycle. This is a laboratory-based, execution-focused role suited to an experienced Development Chemist who can integrate quickly into an established R&D team with minimal ramp-up time.
Key Responsibilities
- Design and execute formulation and/or analytical development studies in support of new product development or existing product improvement.
- Develop, optimise, and where required validate analytical test methods (e.g. HPLC, GC, dissolution, wet chemistry) in line with ICH guidelines.
- Set up, conduct, and monitor stability studies, ensuring samples are tested and reported in line with the approved protocol and schedule.
- Accurately record experimental work and results in laboratory notebooks/ELN, ensuring full compliance with good documentation practice and data integrity principles.
- Prepare technical reports, development summaries, and data packages to support regulatory submissions and technology transfer.
- Support technology transfer of developed formulations/methods to manufacturing or QC, ensuring robust and reproducible handover.
- Troubleshoot formulation, process, or analytical issues arising during development work, applying sound scientific reasoning.
- Maintain laboratory equipment in good working order, ensuring calibration and qualification status is current.
- Collaborate with Process Development, Quality, Regulatory Affairs, and Manufacturing colleagues to progress projects to agreed timelines.
- Adhere to all laboratory health & safety and GMP/GLP requirements as applicable to the development stage of the work.
Essential Qualifications & Experience
- Degree (or higher) in Chemistry, Pharmaceutical Science, Analytical Science, or a related scientific discipline.
- Demonstrable laboratory-based development experience within pharmaceutical, biopharmaceutical, or related industry R&D.
- Practical experience with analytical techniques relevant to the role (e.g. HPLC, GC, UV, dissolution testing, wet chemistry).
- Strong understanding of GMP/GLP, good documentation practice, and data integrity principles as applied to a development environment.
- Experience preparing clear, accurate technical reports and development documentation.
- Available to start within a short notice period, given the contract nature of the role.
Desirable Criteria
- Experience specific to the site's development focus (e.g. oral solid dose formulation, biologics/large molecule analytics, or drug-device combination products).
- Experience with DoE (Design of Experiments) methodologies and associated statistical software (e.g. JMP, Minitab).
- Analytical method validation experience, in line with ICH Q2 guidelines.
- Prior contract/temporary R&D experience, with the ability to add value quickly in an unfamiliar project.
- Experience supporting technology transfer to manufacturing or an external site.
Person Specification
- Strong analytical and problem-solving skills, with a methodical, scientifically rigorous approach to laboratory work.
- Self-sufficient and effective from day one, able to integrate quickly into an established development team.
- Excellent written communication skills, particularly for technical reports and development documentation.
- Meticulous attention to detail, particularly around data integrity and documentation accuracy.
- Collaborative team player, comfortable working cross-functionally to progress shared project timelines.