Job Description
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:
- Bachelor’s degree (Master’s preferred) 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 <711>
- 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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