Sr. Analytical Chemist

ELIXIR MEDICAL CORPORATION; Milpitas (CA); On-site; USD 105,000 - 130,000; Full time

Job summary

ELIXIR MEDICAL CORPORATION in Milpitas, CA seeks an experienced analytical scientist to lead method development and validation for regulatory submissions. You will mentor junior staff, collaborate across R&D, Quality, Regulatory Affairs, and Manufacturing, and ensure cGMP compliance while driving data integrity and timely project delivery.

The role requires 8+ years (BSc) or 6+ years (MSc) of hands-on pharma analytics, expertise in HPLC/GC/LC-MS, and strong technical writing ability.

Qualifications

• Bachelor’s or Master’s degree in analytical sciences; hands-on experience required.
• Minimum 6–8 years in analytical work in pharma/medical devices.
• Strong expertise in method development, validation, and regulatory analytical sections.

Responsibilities

• Perform analytical chemistry research to develop robust assays.
• Develop, establish, and validate testing methods for materials and products.
• Establish, validate, and document compound identification methods.
• Ensure cGMP, safety and regulatory compliance in all activities.
• Investigate complex analytical challenges and document investigations with root-cause analysis.
• Prepare technical documentation and reports for regulatory submissions.
• Collaborate with R&D, Quality, Regulatory Affairs and Manufacturing.
• Mentor junior scientists and analysts; support data quality and reporting.

Skills

Analytical method development

Validation of testing methods

cGMP compliance

Root-cause analysis

Mentoring

Data interpretation

Chromatography software

Education

Bachelor’s degree in Analytical Chemistry

Master’s degree preferred

Tools

Empower

ChemStation

LIMS

Job description

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.

Qualifications and Skills

• 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 <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

Education Requirements

• 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.