Method Development Lead

Nexus Life Sciences; Manchester; On-site; GBP 36,000 - 60,000; Full time

Benefits offered by this job

Leadership opportunity

Professional development and training

Collaborative, supportive culture

Opportunity to contribute to bioanalyt

Job summary

Nexus Life Sciences in Manchester seeks 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, guiding the Method Development & Validation team to ensure robust methods and regulatory compliance.

The ideal candidate has 4+ years in a GxP lab (2+ in management), strong expertise in HPLC/UPLC/LCMSMS, and hands-on experience with DOE, Minitab, Empower, and

Qualifications

• Degree in Biochemistry, Biomedical Science, or related field.
• 4+ years in a GxP laboratory with 2+ years in management.
• Experience with HPLC/UPLC/LCMSMS and chromatography data systems.
• Knowledge of GLP, regulatory requirements, and SOPs.

Responsibilities

• Lead method development and validation as a subject matter expert.
• Optimise extraction techniques, chromatography methods, and LC columns.
• Mentor and manage the Method Development & Validation team.
• Ensure GLP compliance and adherence to SOPs and guidelines.
• Troubleshoot analytical methods and drive improvements.
• Oversee lab operations and consumables spend.
• Write and approve Methods of Analysis; transfer validated methods.
• Support regulatory submissions and respond to queries.
• Lead investigations, CAPAs, and continuous improvement.
• Prepare, review, and ensure GLP SOP adherence.
• Lead team meetings and staff development sessions.

Skills

HPLC/UPLC

LCMS/MS

Method development

Validation

SPE

LLE

GLP

DOE

Minitab

MassLynx

Empower

Education

Degree in Biochemistry, Biomedical Science, or related field

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.