Senior Analytical Scientist
Dexcom
Summary
We are seeking a highly skilled and motivated Senior Scientist with expertise in analytical method development, method validation, method transfer and QC instrument maintenance. The successful candidate will lead analytical efforts to ensure the successful method validation to meet commercial requirements, and drive method transfer across Dexcom's sites. This role is critical to supporting R&D, product development, and quality assurance across a range of polymeric materials.
Job description
Where you come in
- Serve as a SME in a cross-functional team driving technical solution or decision pertinent to analytical matters.
- Act as QC testing technical lead to ensure material quality control requirements are met under Dexcom QMS systems.
- Apply design of experiment and statistical analysis to drive evidence-based conclusions and recommendations, author technical reports and protocols, present results for stage-appropriate technical design review and decision making.
- Work with cross-functional teams in material design, selection, and qualification, to support design down select and continuous improvement including raw material sourcing, safety assessment, and product specification.
- Understand and apply basic laboratory safety protocols, chemical hygiene, and dispose chemical waste according to company and local EHS regulations.
What makes you successful
- Demonstrated hands-on expertise with GPC-MALS, DLS, FTIR, viscometry, and Instron systems, including instrument operation, troubleshooting, maintenance, and basic repair.
- Ability to assess instrument readiness for QC use, including qualification requirements, system suitability, and compliance with applicable regulatory and quality requirements.
- Strong experience in protein and enzyme characterizations by utilizing plate reader, LC-MS and HPLC instruments.
- Solid understanding of current regulatory expectations and industry practices for analytical method validation, verification, and method transfer in a regulated environment.
- Extensive experience transferring analytical methods from R&D to QC/manufacturing laboratories, including development of transfer strategies and protocols, assessment and qualification of equivalent instrumentation, method gap/risk assessments, execution and documentation of method transfer activities, troubleshooting, and training of receiving laboratory personnel.
- Strong knowledge of QC laboratory documentation practices, including SOPs, test methods, protocols, reports, controlled worksheets/forms, instrument records, and other documentation required to support compliant routine testing.
- Experience with LIMS implementation or optimization within an analytical/QC laboratory to improve laboratory efficiency, sample and data traceability, documentation control, and data integrity is strongly preferred.
Requirements
- Bachelor's degree in a technical discipline and a minimum of 5-8 years related experience, or Master's degree and 2-5 years equivalent industry experience, or PhD and 0-2 years experience
- Hands-on expertise with GPC-MALS, DLS, FTIR, viscometry, and Instron systems
- Experience in protein and enzyme characterizations using plate reader, LC-MS and HPLC instruments
- Understanding of regulatory expectations for analytical method validation, verification, and method transfer in a regulated environment
- Experience transferring analytical methods from R&D to QC/manufacturing laboratories
- Knowledge of QC laboratory documentation practices including SOPs, test methods, protocols, reports, controlled worksheets/forms, instrument records
- Experience with LIMS implementation or optimization within an analytical/QC laboratory is strongly preferred
Benefits
- Comprehensive benefits program
- Growth opportunities
- Career development
- Tuition reimbursement
Company overview
Dexcom, Inc. is a pioneering American healthcare company specializing in the development, manufacturing, and distribution of continuous glucose monitoring (CGM) systems for diabetes management. Founded in 1999 and headquartered in San Diego, California, Dexcom has transformed diabetes care through innovative biosensing technology that provides real-time glucose readings. The company's flagship products, including the G-series CGM systems, offer industry-leading accuracy and extended wear times, with the latest G7 model providing up to 15.5 days of continuous monitoring. As a publicly traded company listed on Nasdaq (DXCM) and a component of both the Nasdaq-100 and S&P 500 indices, Dexcom operates globally with manufacturing facilities in Arizona, Malaysia, and Ireland. With over 10,300 employees worldwide, the company generates approximately $4 billion in annual revenue and maintains strategic partnerships with major healthcare technology companies. Dexcom's mission focuses on empowering people with diabetes to take control of their health through advanced monitoring solutions that improve clinical outcomes and quality of life.