Senior Scientist, Analytical Chemistry

Description

RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company’s mission is to revolutionize the premium cataract surgery experience by allowing surgeons to partner with their patients to achieve optimized results for every unique eye.

OVERVIEW:

Reporting to the Vice President of R&D Chemistry, the Senior Scientist, Analytical Chemistry will lead chemical characterization of the Light Adjustable Lens, an intraocular lens, and other implantable ophthalmic medical devices. This role provides the analytical chemistry expertise required to support product development, verification, commercialization, and troubleshooting.

This laboratory-based role will develop, execute, and interpret analytical methods used to characterize raw materials, intermediates, finished products, extractables, leachables, impurities, degradation products, and process residuals. The successful candidate will serve as the analytical chemistry subject matter expert and collaborate closely with materials scientists, chemists, optical and mechanical engineers, process engineers, Analytical Chemistry QC, Quality, Manufacturing, Regulatory Affairs, and external laboratories.

The position supports product development, design verification, and troubleshooting by leading chemical characterization of materials and finished devices, generating high-quality analytical data, developing robust test methods, and translating results into scientifically defensible conclusions and recommendations. The successful candidate is not expected to be the primary expert in polymer physics or materials science but must understand polymer and biomaterial systems well enough to design relevant studies, interpret material behavior, and partner effectively with R&D and Operations on investigations involving silicone, acrylic, and related medical-device materials.

Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop, optimize, qualify, validate, and execute analytical methods supporting product development, design verification, manufacturing support, and regulatory submissions.
• Perform analytical testing and data interpretation using chromatographic, spectroscopic, and related techniques including GC-MS, GC-FID, headspace GC, HPLC/UPLC, LC-MS, GPC/SEC, FTIR, Raman, UV-Vis, and related methodologies.
• Serve as the technical lead for chemical characterization of materials and finished devices, including extractables and leachables, hydrolytic stability, photostability, and other studies conducted in accordance with applicable ISO 11979 and ISO 10993 requirements. Own analytical strategy, method selection, study execution, data analysis, scientific interpretation, and reporting.
• Characterize impurities, residues, additives, degradation products, process residuals, and other chemical species associated with ophthalmic materials and finished devices, and assess their likely source and relevance to product performance or safety.
• Collaborate with R&D functions, including materials scientists, optical and mechanical engineers, and process engineers, as well as Operations, to investigate product performance, material changes, aging effects, process interactions, and development-related technical issues and to recommend scientifically justified next steps.
• Train and mentor junior laboratory staff in sample preparation, routine analytical testing, data quality expectations, and safe, compliant laboratory practices.
• Author analytical protocols, test methods, validation reports, technical reports, summaries, and supporting documentation for regulatory submissions.
• Analyze and interpret complex datasets and communicate results and recommendations to cross-functional teams.
• Lead or support root-cause investigations involving materials, finished products, manufacturing processes, analytical methods, and process or material changes. Integrate analytical results with input from materials scientists and engineers to identify likely mechanisms, evaluate competing hypotheses, and recommend corrective or development actions.
• Collaborate with Analytical Chemistry QC and external laboratories to transfer methods, review data packages, resolve analytical issues, and ensure data integrity.
• Evaluate and implement new analytical technologies and methodologies to expand laboratory capabilities.
• Maintain laboratory organization, instrumentation readiness, and compliance with applicable procedures and quality requirements.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

• Strong foundation in analytical chemistry and method development.
• Experience developing, validating, troubleshooting, and transferring analytical methods.
• Hands-on expertise with chromatographic techniques including GC-MS, GC-FID, headspace GC, HPLC/UPLC, LC-MS, and GPC/SEC.
• Experience interpreting chromatographic and mass spectrometric data and developing scientifically defensible conclusions.
• Knowledge of extractables and leachables testing, impurity characterization, degradation-product analysis, and chemical characterization principles.
• Familiarity with spectroscopic techniques including FTIR, Raman, UV-Vis, NMR, and related analytical methods.
• Hands-on experience with relevant materials-characterization techniques, such as thermogravimetric analysis, differential scanning calorimetry, tensile testing, and nanoindentation, and the ability to integrate these results with chemical characterization data.
• Working knowledge of polymeric and biomaterial systems sufficient to support analytical investigations involving silicone- and acrylic-based materials and to connect chemical composition, structure, processing, aging, and degradation with observed material and product behavior.
• Strong statistical analysis, experimental design, and data interpretation skills.
• Excellent technical writing and documentation abilities.
• Ability to work independently while collaborating effectively with materials scientists, optical scientists and engineers, mechanical engineers, process engineers, quality professionals, manufacturing personnel, regulatory partners, and external laboratories.
• Working knowledge of FDA-regulated product development and applicable analytical and chemical-characterization expectations under ISO 11979 and ISO 10993 is preferred.

SUPERVISORY RESPONSIBILITIES:

• This position may supervise a laboratory technician, depending on the successful candidate’s experience and organizational needs, and will provide technical direction and mentorship to junior laboratory staff.

EDUCATION, EXPERIENCE, AND TRAINING:

• Ph.D. in Analytical Chemistry, Chemistry, Polymer Chemistry, Materials Science or a related scientific discipline with substantial analytical training.
• 3+ years (preferred) of relevant industrial analytical chemistry experience in product development, verification, manufacturing support, or troubleshooting in medical devices, pharmaceuticals, biomaterials, or another regulated technical environment.
• Demonstrated experience applying analytical methods to polymeric or biomaterial systems, including silicones, acrylics, hydrogels, or related soft materials, is highly desirable.
• Experience with chemical characterization such as extractables and leachables, hydrolytic, and photostability studies, method validation, and regulatory-supporting analytical activities preferred.
• Exposure to polymeric or biomaterial systems, including silicones, acrylics, hydrogels, or related materials, is highly desirable.
• Experience supporting FDA-regulated products or equivalent quality systems preferred.

CERTIFICATES, LICENSES, REGISTRATIONS:

• None

Notice to Staffing Agencies and Search Firms:

RxSight does not accept unsolicited resumes or candidate submissions from staffing agencies or search firms for any employment opportunities. All agency engagements must be authorized in writing for a specific position by RxSight’s Talent Acquisition department. Any resumes or candidate information submitted without such specific engagement will be considered unsolicited and the property of RxSight. No fees will be paid in the event a candidate is hired under these circumstances.