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Aliso Viejo

    Senior Analytical Chemist - Aliso Viejo, United States - Simply Biotech

    Simply Biotech
    Simply Biotech Aliso Viejo, United States

    3 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Sr. R&D Analytical Chemist- Simply Biotech

    OVERVIEW

    Are you looking for a new career opportunity with an exciting biotech company? Then we've got the right team for you In this role, you're responsible for the duties listed below.

    Immediate opening for a Sr. R&D Analytical Chemist with a biopharmaceutical company in Aliso Viejo, CA who possesses:

    • PhD in analytical chemistry, toxicology, pharma sciences or related
    • 3-10 years exp in pharma or med device.
    • Experience with analytical characterization techniques, specifically GC and GC-MS
    • Experience with development of those methods (GC, GC-MS)
    • Experience putting regulatory documents together for the FDA and/or EPA

    Email resumes to or call

    FULL DESCRIPTION: The desired candidate must have the capability to assist and coordinate development of the next generation light adjustable optical device, 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.

    The selected candidate will be responsible for:

    • 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.

    The selected candidate will also possess:

    • 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.

    Salary Range: $130k-160k/yr

    For immediate and confidential consideration, please email your resume to or call More information can be found at

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