Senior Research and Development Analytical Chemist

23 hours ago


Aliso Viejo, California, United States RxSight, Inc. Full time
Job Title: Senior R&D Analytical Chemist

RxSight, Inc. is a leading ophthalmic medical technology corporation headquartered in Aliso Viejo, California. We are revolutionizing the premium cataract surgery experience by allowing surgeons to partner with their patients to achieve optimized results for every unique eye.

Job Summary:

We are seeking a highly skilled Senior R&D Analytical Chemist to join our team. The ideal candidate will have a strong background in analytical chemistry and experience in the pharmaceutical industry. The successful candidate will be responsible for developing and validating new analytical procedures, establishing a documentation system, and troubleshooting problems associated with analytical methods.

Key Responsibilities:
  • Develop and validate new analytical procedures in accordance with USP, ICH, AOAC, and ISO requirements.
  • Establish a documentation system for drafting, reviewing, and approving method validation protocols, reports, and analytical method SOPs.
  • Troubleshoot problems associated with analytical methods for lens components, including raw materials, finished product method development, quantitative and qualitative analysis, and improvement of analytical methodologies.
  • Act as R&D liaison to Regulatory Affairs responsible for defining and supplying technical information on products to Regulatory Affairs for regulatory submissions.
  • Be responsible for maintaining and expanding analytical capabilities of the department.
Requirements:
  • A Ph.D. degree in Analytical Chemistry, Toxicology, Pharmaceutical Sciences, or a related discipline.
  • 7-10 years of experience in the pharmaceutical industry, or a combination of industry experience and postgraduate research.
  • A profound understanding of FDA and related regulations, coupled with the ability to work collaboratively within cross-functional teams, and develop regulatory strategies.
  • Hands-on proficiency in various chromatography methods such as HPLC, GC, GCMS, GPC, as well as spectroscopic methods including UV, FTIR, and NMR.
  • Excellent verbal communication and technical writing skills.
What We Offer:

RxSight, Inc. offers a competitive salary and benefits package, as well as opportunities for professional growth and development.



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