Senior Analytical Chemist - Method Dev, Validation & cGMP

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

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.