Method Development Lead

Nexus Life Sciences; High Wycombe; Vor Ort; GBP 48.000 - 60.000; Vollzeit

Zusammenfassung

Nexus Life Sciences seeks an MS Method Development Lead to drive the development and validation of LCMSMS bioanalytical methods under GxP standards. This role combines technical expertise with team leadership.

Responsibilities include leading method development, optimising extraction and chromatography, mentoring the MD&V team, and supporting regulatory submissions while ensuring GLP SOP compliance. Strong leadership and problem-solving skills are essential.

Qualifikationen

• GxP laboratory experience required.
• Experience leading method development and validation.
• Strong knowledge of LC-MS/MS instrumentation.
• Familiarity with GLP and regulatory guidelines.
• Experience with CAPA investigations and improvements.

Aufgaben

• Lead method development and validation as SME.
• Optimise extraction, chromatography and LC columns.
• Mentor the MD&V team and manage resources.
• Ensure compliance with GLP, SOPs and guidelines.
• Troubleshoot methods and implement improvements.
• Support regulatory submissions and respond to queries.
• Oversee cost-effective laboratory operations.
• Write Methods of Analysis and transfer to teams.
• Lead team meetings and staff development.

Kenntnisse

GxP team management

LC-MS/MS

HPLC/UPLC

Method development

Regulatory compliance

Problem solving

Communication

Leadership

Extraction techniques (SPE/LLE)

Ausbildung

Biochemistry / Biomedical Science degree

Tools

Empower

MassLynx

Minitab

Jobbeschreibung

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.