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Senior R&D Analytical Chemist
1 month ago
RxSight, Inc. is a leading ophthalmic medical technology corporation 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.
Key Responsibilities:
The ideal 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.
Responsibilities include developing, validating new analytical procedures in accordance with USP, ICH, AOAC and ISO requirements, establishing a documentation system for drafting, reviewing, and approving method validation protocols, reports, and analytical method SOPs.
Requirements:
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.
Working Conditions:
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
Salary Range:
$130,000 To $160,000 Per Year
