Principal Analytical Chemist

Job Description

MAJOR DUTIES AND RESPONSIBILITIES

Responsibilities include, but are not limited to :

• Provide critical analytical support for regulatory submissions, including Investigational Device Exemptions (IDEs), Premarket Approvals (PMAs), or combination product filings across various global regions.
• Lead method development, validation, and transfer for drug substances and drug products using HPLC, GPC, GC, UV-Vis, FTIR, thermal analysis and USP Apparatus 7 dissolution testing.
• Design and perform analytical testing for assay, purity, residual solvents, degradation products, and drug release profiles, in accordance with ICH, EMA, USP and FDA requirements.
• Author and review technical reports, stability protocols / reports, specifications, and analytical CMC documentation to support regulatory submissions.
• Investigate and resolve complex analytical challenges and laboratory investigations (e.g., OOS, OOT) with thorough root-cause analysis and data interpretation with report.
• Develop and revise Standard Operating Procedures (SOPs), Installation-Operation-Qualification of existing and / or new equipment and analytical software.
• Develop and revise analytical specifications for drug substances and drug products in collaboration with cross- functional team members. Serve as subject matter expert (SME) during internal and external audits and inspections; ensure compliance with cGMP, GLP, ISO, and FDA regulations.
• Collaborate cross-functionally with R&D, Quality, Regulatory Affairs, and Manufacturing teams to align analytical strategies with project goals and timelines during various stages of development.
• Mentor junior scientists and analysts, providing scientific and technical guidance to support high-quality data generation, critical review, and reporting.
• As part of the analytical team member, maintain, trouble-shoot and calibrate (if needed) analytical equipment performances with documentation, mentoring junior members (as needed).
• Maintain up-to-date knowledge of evolving analytical technologies, regulatory expectations, and industry trends for drug substance and drug products.

QUALIFICATIONS

Experience & Education :