Method Development Lead

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

Job summary

Nexus Life Sciences seeks an MS Method Development Lead to drive LCMSMS bioanalytical method development and validation under GxP standards.

The role combines technical expertise and team leadership, overseeing a dedicated MD&V team while ensuring GLP compliance and regulatory readiness.

Qualifications

• Degree in Biochemistry, Biomedical Science, or related field.
• 4+ years in a GxP laboratory with 2+ years in management.
• Expertise in HPLC, UPLC, LCMSMS and chromatography data systems.
• Knowledge of protein precipitation, SPE, and Liquid-Liquid extraction.
• Understanding of regulatory and GLP requirements.
• Strong communication, organisational, and leadership skills.

Responsibilities

• Lead method development and validation as a subject matter expert.
• Optimise extraction techniques, chromatography methods, and LC columns.
• Mentor the Method Development & Validation team.
• Ensure GLP compliance, SOP adherence, and regulatory alignment.
• Troubleshoot analytical methods and implement improvements.
• Oversee cost-effective laboratory operations and consumables.
• Write and approve Methods of Analysis and transfer validated methods.
• Support regulatory submissions and respond to queries.
• Drive CAPAs and continuous improvement; lead team meetings.

Skills

GxP Laboratory

HPLC

UPLC

LCMSMS

Method Development

Validation

Regulatory & GLP

Leadership

Communication

Troubleshooting

Protein precipitation

SPE & LLE

Education

Bachelor's degree in Biochemistry/Biomedical Science

Tools

Empower

Mass Lynx

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.