WuXi AppTec

  • Analytical Chemistry Scientist

    Job Locations US-CA-San Diego
    Job ID
    2018-4080
  • Overview

    This position reports to the Analytical Chemistry Department at STA Pharmaceutical US LLC. STA Pharmaceutical US LLC, a WuXi AppTec Company, is a contract development and manufacturing organization focused on providing high quality process development, R&D, GLP Tox lots and up to P1/P2 GMP small molecule manufacturing services to the biopharmaceutical industry. The candidate will work with a team of analytical scientists in conjunction with the Chemical Research and Development Department and assist in developing, safe, efficient and easily scalable processes for producing starting materials, intermediates and active pharmaceutical ingredients (API’s). In addition, the candidate will work with Quality Assurance to ensure that high quality standards are maintained and appropriate documentation such as analytical test release packages are completed in a timely manner.

    Responsibilities

    • Perform analytical activities including method development, transfer and validation as well as, IPC’s, cleaning verification, release testing of incoming materials, intermediates, API’s and reference standards.
    • Perform analytical work to address chemical stability and structure elucidation including forced degradation, stability studies and dissolution testing.
    • Maintenance of analytical equipment including calibration/qualification and system suitability testing for cGMP activities.
    • Adhere to cGMP compliant procedures and data management systems to archive and track analytical activities.
    • Authors/co-authors SOP’s, technical reports and sections for regulatory filings.
    • Actively communicates, consults and collaborates with colleagues to ensure optimal execution and record of analytical activities.

    Qualifications

    Technical Skills / Knowledge:

    • Significant experience in analytical method development, validation and QC testing for small molecules.
    • Experience in supporting all phases of API development, ideally spanning early development to registration.
    • Demonstrate understanding of cGMP manufacturing for biopharmaceutical products.

     

    Independence/ Accountability:

    • Demonstrated success working effectively outside typical procedures when required.
    • Have a bias for action and display a sense of urgency.
    • Demonstrate the ability to follow instructions and work efficiently under guidance.

     

     

     

     

    Problem Solving:

    Provide technical and trouble-shooting support for analytical instrumentation and all analytical development activities.

     

     

    Communication Skills:

    • Provide regular updates, documentation and communication of analytical development results to supervisor and development team, if needed.
    • Collate and present results in various forms, such as, technical reports and oral presentations.

     

    • The candidate will have shown proficiency in on-bench analytical work, solve analytical challenges, and have experience in writing analytical reports.
    • The position requires experience in drug substance analytical method development and validation, as well as good understanding of analytical equipment and cGMPs ICH and relevant FDA guidelines.
    • CMO/CRO and drug product development experience is beneficial.

     

    Customary Education and Experience:

    MS/BS in analytical chemistry or related field with 5+ years of relevant experience.

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