Clinical & Validation Principal

Clinical & Validation Principal

Join a leading R&D organisation and take ownership of bioanalytical method development and validation activities supporting global clinical programmes. This is an excellent opportunity for an experienced scientific leader to combine technical expertise with team management in a highly regulated laboratory environment.

Key Responsibilities

* Lead the development, optimisation, validation, and transfer of bioanalytical methods.

* Provide technical expertise in sample preparation and extraction techniques, including SPE, protein precipitation, and liquid-liquid extraction.

* Oversee and optimise HPLC, UPLC, and LC-MS/MS analytical platforms.

* Troubleshoot analytical challenges and lead investigations and CAPA activities.

* Manage, mentor, and develop a high-performing laboratory team.

* Ensure compliance with GLP, SOPs, and regulatory requirements.

* Support audits, regulatory submissions, and technical documentation.

* Drive continuous improvement across laboratory operations and analytical processes.

Essential Requirements

* Degree in Biochemistry, Biomedical Sciences, Analytical Chemistry, or a related discipline.

* Strong experience within a GxP-regulated laboratory environment.

* Proven leadership or people management experience.

* Expertise in HPLC, UPLC, and LC-MS/MS.

* Demonstrated success in bioanalytical method development and validation.

* Strong understanding of extraction techniques and complex biological matrices.

* Excellent problem-solving, organisational, and communication skills.

* Sound knowledge of GLP and regulatory expectations.

Desirable

* Experience with DoE and statistical software such as Minitab.

* Familiarity with Empower, MassLynx, or similar chromatography software.

* Exposure to GC techniques and regulatory inspections.

Location: Northern Ireland (Onsite)