Senior R&D Analytical Chemist

3 weeks ago

Aliso Viejo, United States RXSIGHT INC Full time
Job DescriptionJob DescriptionDescription:

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:

The desired candidate must have the capability to assist and coordinate development of the next generation light adjustable IOL, as well as the maintenance of current commercial products while ensuring compliance with FDA regulatory requirements. The candidate will play a pivotal role in leading technical investigations and providing risk assessment for product, materials, or process change, (including those related to suppliers, manufacturing sites, or protocol changes). Collaboration with cross-functional teams to develop regulatory strategies and providing subject matter expertise for material specification justification, setting, and monitoring is integral to this role.


ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Develop, 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.
  • Trouble-shoot 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:

Required Knowledge, SKILLS, and Abilities:

  • A Ph.D. degree in Analytical Chemistry, Toxicology, Pharmaceutical Sciences, or a related discipline is a prerequisite for this role. The candidate should ideally possess 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, develop regulatory strategies is highly desirable.
  • Hands-on proficiency in various chromatography methods such as HPLC, GC, GCMS, GPC, as well as spectroscopic methods including UV, FTIR, and NMR, is essential.
  • Excellent verbal communication and technical writing skills are a must, alongside a strong working knowledge of the professional field and industry standards.
  • The ideal candidate should be adept at working with minimal supervision, relying on their experience and judgment to plan and achieve assigned goals.

SUPERVISORY RESPONSIBILITIES:

  • None

EDUCATION, EXPERIENCE, and TRAINING:

  • Training to be completed per the training plan for this position as maintained in the document control system
  • The training requirements on TRN-10007 Insider Trading Policy, TRN-10008 Global Anti-Bribery and Anti-Corruption Policy and TRN-10009 Code of Business Conducts and Ethics must be diligently completed within 30 days from the hiring date and on an annual basis

CERTIFICATES, LICENSES, REGISTRATIONS:

  • None

COMPUTER SKILLS:

  • Proficient user of MS office, Power BI

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