Method Development Lead

Nexus Life Sciences; Leicester; Hybrid; GBP 36,000 - 60,000; Full time

Job summary

Nexus Life Sciences is seeking an MS Method Development Lead to drive the development and validation of LCMSMS bioanalytical methods under GxP standards. The role combines technical leadership with mentoring and cross-functional collaboration.

You will oversee method development, optimisation of extraction and chromatography, and ensure adherence to GLP/SOPs while supporting regulatory submissions and improvements.

Qualifications

• Degree in Biochemistry, Biomedical Science or related field.
• GxP laboratory experience with leadership responsibilities.
• Experience in method development, optimisation and validation.
• Strong regulatory and GLP awareness.

Responsibilities

• Lead method development and validation as SME for LCMSMS.
• Optimise extraction, chromatography, and LC columns.
• Mentor the Method Development & Validation team.
• Ensure GLP, SOPs and guidelines compliance.
• Troubleshoot methods and implement improvements.
• Support regulatory submissions and resolve queries.
• Prepare, review, and transfer validated methods to teams.
• Lead investigations and CAPA activities.

Skills

GxP leadership

Team leadership

Analytical troubleshooting

Regulatory compliance

Communication

Education

Degree in Biochemistry or related field

Tools

HPLC

UPLC

LCMSMS

Chromatography data systems

Empower

MassLynx

Minitab

Job description

About the Role

We are seeking a highly skilled MS Method Development Lead to drive the development and validation of LCMSMS bioanalytical methods under GxP standards.

This role combines technical expertise and team leadership.

Responsibilities

• Key duties include:
• Leading method development and validation as a subject matter expert.
• Optimising analytical extraction techniques, chromatography methods, and LC columns.
• Managing and mentoring the Method Development & Validation team.
• Ensuring compliance with GLP, SOPs, and international guidelines.
• Troubleshooting analytical methods and recommending improvements.
• Overseeing cost-effective laboratory operations and consumable spend.
• Writing and approving Methods of Analysis and transferring validated methods to analytical teams.
• Supporting regulatory submissions and resolving regulatory queries.
• Conducting investigations, implementing CAPAs, and driving continuous improvement.
• Preparing, reviewing, and ensuring adherence to GLP SOPs.
• Leading team meetings and staff development sessions.

Qualifications

• Degree in Biochemistry, Biomedical Science, or related field.

Required Skills

• 4+ years in a GxP laboratory (2+ years in management).
• Expertise in HPLC, UPLC, LCMSMS, and chromatography data systems.
• Proficiency in method development, optimisation, and validation.
• Strong problem-solving and troubleshooting capabilities.
• Knowledge of protein precipitation, SPE, and Liquid-Liquid extraction techniques.
• Understanding of regulatory and GLP requirements.
• Strong communication, organisational, and leadership skills.

Preferred Skills

• Experience with Design of Experiments (DOE) for method optimisation.
• Proficiency in Minitab/statistical software.
• Experience with Empower and Mass Lynx data systems.
• GC experience and familiarity with regulatory inspections.

Pay range and compensation package

• Competitive salary up to £60,000.
• Leadership opportunity in a cutting-edge lab environment.
• Professional development and training opportunities.
• Supportive, collaborative work culture.
• Chance to contribute to innovative bioanalytical projects.