Bioanalytical Supervisor / Study Director

About the role

We are looking for an experienced Senior Bioanalytical / Analytical Scientist to lead our analytical department. The role focuses on LC‑MS/MS method development, validation, sample analysis and ensuring GLP compliance while providing technical leadership to the laboratory team.

Key responsibilities

• Develop, optimise and validate analytical methods, including partial validation.
• Perform LC‑MS/MS analysis of clinical and study samples.
• Prepare method development protocols, reports and related documentation.
• Review analytical data for accuracy, integrity, completeness and regulatory compliance.
• Ensure testing follows GLP, SOPs, protocols and regulatory requirements.
• Approve analytical data and prepare final results for compliance review and pharmacokinetics submission.
• Support CAPA, deviations, change controls, audits and laboratory quality activities.
• Supervise, train and provide technical guidance to laboratory analysts.

Required profile

• B.Sc. or M.Sc. in Pharmacy, Chemistry or a related scientific discipline.
• 8–10 years of relevant experience in pharmaceutical, bioanalytical or clinical research laboratories.
• Minimum 4 years of hands‑on experience in analytical method development and validation.
• Strong practical experience with LC‑MS/MS‑based bioanalytical analysis.
• Experience in GLP‑regulated laboratories and work with biological matrices (highly desirable).
• Knowledge of CAPA, change control, deviations and audit support.
• Proven experience supervising, training and developing analysts.

Required skills

• LC‑MS/MS method development
• Analytical method validation
• Bioanalytical sample analysis
• GLP compliance
• Data review and reporting
• CAPA management
• Change control procedures
• Audit support