Method Development Lead

Nexus Life Sciences; City of Edinburgh; On-site; GBP 36,000 - 60,000; Full time

Job summary

Nexus Life Sciences invites applications for a highly skilled MS Method Development Lead to drive development and validation of LCMSMS bioanalytical methods under GxP standards in Scotland.

The role combines hands-on scientific leadership with management of the Method Development & Validation team, ensuring compliance with GLP, SOPs, and regulatory guidelines, while optimising extraction, chromatography, and data systems.

Qualifications

• A strong background in GxP laboratory work and method development is required.
• Experience leading and mentoring a team in a regulated environment is essential.
• Proven ability to develop and validate LCMSMS methods and optimise chromatography.

Responsibilities

• Lead method development and validation as a subject matter expert.
• Optimise extraction techniques and LC methods for bioanalytical assays.
• Manage and mentor the Method Development & Validation team.
• Ensure GLP compliance, SOP adherence, and regulatory guideline alignment.
• Troubleshoot analytical methods and implement improvements.
• Oversee cost-efficient lab operations and consumable spend.
• Write and approve Methods of Analysis and transfer validation results.
• Support regulatory submissions and respond to regulatory queries.
• Lead investigations, CAPAs, and drive continuous improvement.
• Prepare, review and ensure GLP SOP adherence.
• Lead team meetings and staff development sessions.

Skills

GxP laboratory experience

Team leadership

HPLC/UPLC/LCMSMS

Method development & validation

Troubleshooting

Regulatory compliance

Communication & organisation

Education

Bachelor's degree in Biochemistry 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.