Bioanalytical Validation scientist

Job Title: Clinical Bioanalytical LCMS Scientist

Company Overview:

A leading clinical research organisation committed to advancing healthcare through cutting-edge drug development and clinical research are seeking Clinical Bioanalytical LCMS Scientist to join their team.

Job Overview:

As a Clinical Bioanalytical LCMS Scientist specializing in method validation to ICH guidelines, you will be responsible for designing, optimizing, and validating LCMS-based bioanalytical methods used in clinical studies for the quantitative analysis of drug compounds and their metabolites in biological samples. The successful candidate will work closely with our research teams to support preclinical and clinical studies, contributing to the development of innovative pharmaceutical products.

Key Responsibilities:

Method Validation: Develop and validate LCMS-based bioanalytical methods for the quantification of drug compounds, metabolites, and biomarkers in biological matrices (e.g., plasma, serum, urine) according to 1.             ICH M10 ICH guideline M10 on bioanalytical method validation and study sample analysis (2022) OR PREVIOUSLY US FDA Bioanalytical Method Validation Guidance for Industry (2018)

Instrumentation and Optimization: Operate, maintain, and troubleshoot LCMS / LCMSMS instruments and associated equipment to ensure their optimal performance. Collaborate with the analytical team to improve methods and instrumentation efficiency.

Sample Preparation: Develop and implement sample preparation techniques, including extraction, purification, and derivatization, to enhance method sensitivity and accuracy.

Documentation: Prepare and review method validation protocols, validation reports, and standard operating procedures (SOPs) in compliance with regulatory guidelines and internal quality standards.

Compliance and Quality Assurance: Ensure that all work is performed in compliance with relevant regulatory guidelines, including ICH, FDA, and GLP/GCP requirements. Adhere to quality assurance practices and contribute to audits and inspections as needed.

Data Analysis and Reporting: Analyze experimental data, interpret results, and prepare comprehensive reports for internal review and submission to regulatory authorities.

Cross-Functional Collaboration: Collaborate with other scientific teams, including analytical chemists, pharmacologists, and toxicologists, to support drug development projects and provide bioanalytical expertise.

Training and Mentoring: Train junior staff members and provide guidance on LCMS method development and validation processes.

Requirements:

Bachelor's, Master's, or Ph.D. degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field.

Proven experience in developing and validating LCMS-based bioanalytical methods for the analysis of small molecules in biological samples.

In-depth knowledge of ICH guidelines and relevant regulatory requirements for bioanalytical method validation.

Hands-on experience with LCMS instrumentation, including maintenance, troubleshooting, and method optimization.

Proficiency in data analysis software (e.g., MassHunter, Analyst) and other relevant analytical tools.

Strong attention to detail and a track record of delivering accurate and reliable results.

Excellent communication and interpersonal skills, capable of working effectively in a team-oriented and fast-paced environment.

Problem-solving skills and the ability to adapt to evolving project requirements.

Benefits:

I am unable to disclose all the benefits over advert however should you be suitable for the role please apply and I will reach out and run through the role including company salary and responsibilities.