Method Compliance Lead

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Fixed Term Contract Duration: 36 months 

Key Job Output:

To plan, organise and execute work as an individual contributor to fulfil the operational requirements of the Analytical department, which includes:

Analytical Method Development & Validation

• Development and optimisation of chromatographic methods for assay and related substances (impurities).
• Understanding of forced degradation studies and impurity profiling.
• Execution and interpretation of method validation in accordance with ICH Q2(R1/R2) guidelines

Instrumentation & Troubleshooting

• Advanced operation and troubleshooting of UPLC/HPLC-UV systems.
• Data integrity and compliant use of chromatography data systems (e.g. Empower or equivalent).

Pharmaceutical Quality & Compliance

• Knowledge of GMP principles as applied to analytical laboratories.
• Understanding of pharmacopoeial requirements (BP, USP, Ph. Eur.) for assay and impurity methods.
• Documentation practices for method development reports, validation protocols, and technical justifications.

Project Support & Leadership

• Ability to support or lead defined analytical workstreams within a project.
• Planning, prioritisation, and execution of method development activities to meet project timelines.
• Clear technical communication of risks, outcomes, and recommendations.

Core Job Competencies: 

• High attention to detail with a strong commitment to quality, integrity, and compliance.
• Organised, professional, and able to manage time effectively under pressure while adapting to changing priorities.
• Strong analytical, problem-solving, and decision-making skills with an innovative mindset.
• Results-driven with a sense of urgency and accountability for delivering outcomes.
• Collaborative team player with strong interpersonal skills, emotional intelligence, and professional communication.
• Ability to build effective working relationships across teams and stakeholders.

• At a minimum, a bachelor’s degree (BSc) in Chemistry or a National Diploma in Analytical Chemistry with 2 to 3 years relevant laboratory experience.
• An Honours or Master’s degree in Chemistry will be considered an advantage.
• Experience with the development and validation of chromatographic methods for assay and impurity determination in pharmaceutical products would be highly advantages.
• Demonstrated competency in the operation and troubleshooting of HPLC/ UPLC systems is essential.
• Experience in pharmaceutical QC and stability testing, with exposure to analytical method development and validation, is essential.
• Understanding the application of GMP principles, pharmacopoeial requirements, and data integrity practices within an analytical laboratory environment is preferred.
• Proficiency with the planning and execution of analytical activities within defined projects, including technical problem-solving and effective communication of results.
• Proficiency in MS Word, MS Excel and compilation of scientific justifications, based on data evaluation

***Advert closing date is 05 October 2026***