Analytical Chemistry Consultant

The Analytical Chemistry Consultant will provide expert scientific and technical support across small-molecule drug substance and drug product programmes. The role involves senior-level advisory input, oversight of analytical development and quality control activities, and generation

and review of reliable data to support development decisions, clinical supply and commercial manufacture.

Key Responsibilities:

• Provide expert analytical development and QC advice across chemical and pharmaceutical development programmes, defining testing strategies to assess identity, strength, purity and quality of APIs, intermediates and finished medicines.
• Develop and optimise analytical methods using appropriate techniques such as HPLC, GC, dissolution testing and spectroscopy, selecting sample preparation, detection approaches and operating conditions suitable for the intended use.
• Characterise and quantify process-related impurities, degradation products and residual solvents, collaborating with chemical development teams to understand impurity profiles and support appropriate process controls and specifications.
• Support formulation and manufacturing process development by assessing assay, content uniformity, dissolution, drug release and other relevant quality attributes, interpreting results to guide product and process decisions.
• Develop stability-indicating methods and oversee stability testing, interpreting degradation trends and results to support proposed storage conditions, API retest periods and finished-product shelf life.
• Plan and oversee method qualification, validation and lifecycle activities, preparing and reviewing protocols and reports to demonstrate suitability for intended use in line with development stage and applicable requirements.
• Lead or support analytical method transfer to internal and contract laboratories, reviewing transfer protocols, acceptance criteria and comparative data, and troubleshooting method performance or laboratory implementation issues.
• Develop and review specifications, sampling plans and testing requirements, assess analytical data and certificates of analysis, and provide technical input to material disposition decisions within the applicable quality system.
• Support investigation of out-of-specification and out-of-trend results, reviewing laboratory evidence, assessing potential causes and recommending appropriate corrective actions in collaboration with laboratory teams and quality assurance.
• Prepare and review analytical procedures, development reports and regulatory submission content, overseeing contract laboratory deliverables and aligning activities with GMP, data integrity principles, relevant ICH guidance and project objectives.

Requirements:

• Degree or equivalent in analytical chemistry, pharmaceutical sciences, chemistry, or a related discipline.
• Demonstrated experience delivering analytical development and QC support for small-molecule drug substances and drug products.
• Strong working knowledge of chromatography, relevant product testing, impurity analysis, and stability-indicating method development.
• Proven experience in method validation and transfer, GMP laboratory practices, data review, and investigation of atypical results.
• Comfortable operating in senior advisory or consultancy roles, with the ability to communicate complex analytical concepts clearly to multidisciplinary teams.