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 , 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: Bachelor’s degree (Master’s ) in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related field required Minimum 10 years (BSc) or 8 years (MSc) of hands-on analytical experience in pharmaceuticals, medical devices, or combination products Strong expertise in analytical method development, validation, and CMC analytical sections for regulatory submissions such as IDE or IND, PMA or NDA Demonstrated hands-on proficiency (but not limited to) with HPLC, GC, LC-MS, UV-Vis, thermal analysis and dissolution testing per USP Proven experience authoring SOPs and establishing analytical specifications for both drug substances and drug products Solid understanding of ICH, EMA, USP, FDA, and ISO guidelines for analytical testing and regulatory compliance Skilled in technical writing with the ability to generate clear, concise, and defensible scientific documentation Strong individual contributor with a proven track record of delivering results and experience mentoring junior team members Experience in leading laboratory investigations, driving root cause analysis and implementation of corrective actions to support quality and process improvements Proficiency in chromatography software (e.g., Empower, ChemStation) and familiarity with LIMS or electronic data systems is a plus Critical reviewing and releasing analytical data packages, and assisting in day-to-day team scheduling and workflow coordination Experience in working with CROs establishing expectations and resolutions (if needed), critical reviewing and releasing their data packages

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