JOB DESCRIPTION SUMMARY

As an Analytical Chemist, you will provide expert technical and analytical support to laboratory operations, driving excellence in method development, validation, and troubleshooting. Your role ensures robust analytical performance and regulatory compliance while fostering continuous improvement through data analytics, statistical trending, and data-driven decision-making—making you a key contributor to scientific precision and operational innovation.

QUALIFICATIONS:

• BSc, MSc, or PhD in Analytical Chemistry, Pharmaceutical Sciences, or related field.
• Solid experience in a GMP-regulated pharmaceutical analytical environment.
• Strong background in analytical method development and validation.

SKILLS AND COMPETENCIES:

• Proficiency in chromatographic and spectroscopic techniques.
• Advanced knowledge of statistical tools and software (e.g., Minitab, JMP, Excel, Python/R for data analysis).
• Experience with LIMS, Chromeleon and electronic documentation systems.
• Strong analytical thinking and problem-solving skills.
• Excellent communication, documentation, and project management abilities.

• Lead analytical method development, validation, and transfer in compliance with ICH guidelines.
• Act as SME for advanced analytical techniques (e.g., HPLC, GC, UV-Vis, FTIR, dissolution).
• Perform statistical analysis and trending of laboratory data (e.g., control charts, capability analysis, stability trends).
• Develop and maintain dashboards and reports for monitoring QC performance and product quality.
• Investigate and resolve complex analytical issues (e.g., OOS, OOT, method variability).
• Actively respond to and troubleshoot performance issues in analytical processes and
• Procedures.
• Follow through on specific corrective action items with root causes related to analytical processes and procedures performance.
• Validation and Qualification: Proactively manage and support the introduction, validation, and qualification of new specifications and methods.
• Support data integrity initiatives and ensure compliance with ALCOA+ principles.
• Collaborate with cross-functional teams (QA, Manufacturing, Regulatory) to support product lifecycle management.
• Review and approve technical documentation including protocols, reports, and SOPs.
• Train and mentor analysts in both analytical techniques and data analysis tools.