QC Analytical Scientist

Role Overview

The QC Analytical Scientist will perform laboratory testing and support analytical method validation activities within a GMP-regulated pharmaceutical or biopharmaceutical environment.

The role requires strong practical laboratory experience, sound scientific judgement, and the ability to execute, document, and review analytical work accurately. Experience supporting Process Characterisation Studies would be an added advantage.

Key Responsibilities

• Perform routine and non-routine analytical testing of raw materials, in-process samples, drug substance, drug product, or stability samples.

• Execute laboratory testing in accordance with approved analytical methods, specifications, SOPs, and GMP requirements.

• Support the complete analytical method validation lifecycle, including protocol preparation, laboratory execution, data review, statistical evaluation, reporting, and study closure.

• Evaluate validation characteristics such as accuracy, precision, specificity, linearity, range, robustness, detection limit, and quantitation limit, where applicable.

• Support analytical method qualification, verification, transfer, optimisation, and troubleshooting activities.

• Review analytical data, calculations, chromatograms, instrument outputs, and laboratory records for accuracy, completeness, and compliance.

• Document and support investigations into deviations, atypical results, Out-of-Specification results, and Out-of-Trend results.

• Assist with root-cause analysis and the implementation of corrective and preventive actions.

• Prepare and maintain GMP documentation, including protocols, reports, worksheets, test methods, SOPs, and technical assessments.

• Operate, maintain, and troubleshoot analytical instruments such as HPLC, UPLC, GC, UV-Vis, or other relevant laboratory equipment.

• Support laboratory equipment qualification, calibration, maintenance, and continued compliant use.

• Work closely with QC, Analytical Development, Process Development, Manufacturing, Quality Assurance, and Validation stakeholders.

• Maintain complete, accurate, traceable, and inspection-ready laboratory records in accordance with data-integrity requirements.

• Support laboratory investigations, audits, regulatory inspections, and continuous-improvement initiatives.

Process Characterisation Support

Where applicable, the successful candidate may also:

• Support analytical testing for Process Characterisation Studies.

• Coordinate sample testing and data generation against approved study plans and timelines.

• Review and interpret analytical results to assess the impact of process parameters on product quality attributes.

• Assist with data trending, technical assessments, study documentation, and final reports.

• Collaborate with Process Development, Manufacturing Sciences, Statistics, and Quality teams during study execution.

Candidate Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Science, Biotechnology, Life Sciences, or a related discipline.

• Relevant hands-on analytical laboratory experience within the pharmaceutical, biotechnology, or another GMP-regulated industry.

• Practical experience performing laboratory testing using established analytical methods and instrumentation.

• Demonstrated experience supporting or executing analytical method validation activities.

• Good understanding of method-validation principles and the associated documentation lifecycle.

• Working knowledge of GMP, Good Documentation Practices, data integrity, and laboratory quality systems.

• Familiarity with laboratory investigations, deviations, OOS/OOT results, CAPA, and change control.

• Strong technical-writing, data-review, troubleshooting, and problem-solving skills.

• Able to work independently while collaborating effectively with laboratory and cross-functional stakeholders.

Preferred Experience

• Experience supporting Process Characterisation Studies within a pharmaceutical or biopharmaceutical environment.

• Familiarity with statistical analysis, data trending, or interpretation of process-characterisation data.

• Experience with analytical method transfer, qualification, verification, or optimisation.

• Familiarity with chromatography data systems, LIMS, or other regulated electronic laboratory platforms.