Method Development Lead

Nexus Life Sciences; Portsmouth; Vor Ort; GBP 48.000 - 60.000; Vollzeit

Benefits dieser Stelle

Leadership opportunity in cutting-edge

Professional development

Collaborative work culture

Zusammenfassung

Nexus Life Sciences is seeking a 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 in a cutting-edge lab environment.

The position focuses on leading method development, optimisation of chromatographic methods, and managing a talented team. Strong regulatory knowledge and communication skills are essential.

Qualifikationen

• Must have 4+ years in a GxP laboratory with 2+ years in management.
• Experience in HPLC, UPLC, LCMSMS and chromatography data systems.
• Proficiency in method development, optimisation and validation.
• Knowledge of protein precipitation, SPE and Liquid-Liquid extraction techniques.
• Understanding of regulatory and GLP requirements.
• Strong communication, organisational and leadership skills.

Aufgaben

• Lead method development and validation as a subject matter expert.
• Optimize analytical extraction techniques, chromatography methods, and LC columns.
• Manage and mentor the Method Development & Validation team.
• Ensure compliance with GLP, SOPs, and international guidelines.
• Troubleshoot analytical methods and implement improvements.
• Oversee cost-effective laboratory operations and consumables spend.
• Write and approve Methods of Analysis and transfer validated methods to teams.
• Support regulatory submissions and address regulatory queries.
• Conduct investigations, implement CAPAs, and drive continuous improvement.
• Prepare, review and ensure adherence to GLP SOPs.
• Lead team meetings and staff development sessions.

Kenntnisse

HPLC

UPLC

LCMSMS

GxP

Method development

SOPs

Ausbildung

Biochemistry / Biomedical Science

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.