Method Development Lead

Nexus Life Sciences; Hemel Hempstead; On-site; GBP 50,000 - 60,000; Full time

Benefits offered by this job

Leadership opportunity

Professional development

Training opportunities

Collaborative culture

Job summary

Nexus Life Sciences in Hemel Hempstead is seeking an experienced 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.

The successful candidate will lead method development and validation, optimise extraction and chromatography, mentor the M&D team, ensure GLP compliance, support regulatory submissions, and drive continuous improvement in a cutting-edge bioanalytical lab

Qualifications

• Degree in Biochemistry, Biomedical Science, or related field.
• 4+ years in a GxP laboratory with at least 2 years in management.
• Expertise in HPLC/UPLC/LCMSMS and chromatography data systems.

Responsibilities

• Lead method development and validation as SME.
• Optimize extraction techniques, chromatography methods, and LC columns.
• Mentor the Method Development & Validation team.
• Ensure GLP, SOPs, and regulatory guidelines compliance.
• Troubleshoot methods and drive improvements.
• Support regulatory submissions and CAPA initiatives.
• Lead team meetings and staff development sessions.

Skills

HPLC

UPLC

LCMSMS

Method development

Leadership

Regulatory knowledge

SPE/PP extraction

DOE (preferred)

Mass Spectrometry data handling

Minitab/ Empower/ Mass Lynx

Education

Biochemistry / Biomedical Science degree

Tools

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.