Sr. Analytical Chemist

Responsibilities will include, but not be limited to:

• Perform analytical chemistry research to develop robust assays based on new and existing methodologies.
• Develop, establish, and validate testing methods used to control raw materials, in-process/production intermediates, and final products.
• Establish, validate, and document new or existing compound identification methods.
• Conduct all laboratory and documentation activities in compliance with cGMP, safety, and applicable regulatory requirements.
• Investigate and resolve complex analytical challenges and laboratory investigations (e.g., Out-of-Specification and Out-of-Trend results), applying thorough root-cause analysis, sound data interpretation, and clear investigative reporting.
• Prepare and maintain accurate technical documentation, protocols, and reports to support method development, validation, and regulatory submissions.
• Support company goals and objectives, policies and procedures, ISO/MDD/MDR requirements, the Quality System Regulation, and other regulatory requirements
• 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.

• Minimum 8 years (BSc) or 6 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, Chem Station) 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

• Bachelor’s degree (Master’s preferred) in Analytical Chemistry, Pharmaceutical Sciences, Chemistry or equivalent education/experience required

This position is based in Milpitas, CA and is an onsite position. The salary range of $105K – $130K based on factors including experience, skills, etc.