Element Materials Technology

  • Sr Analytical Chemist

    Job Locations US-DE-Wilmington
    ID
    2019-3953
  • Overview

    Element has an opportunity for Senior Analytical Chemist. The Senior Analytical Development Chemist works with a team of chemists and other scientists involved in analytical research and related activities to support developmental studies for new and generic drug products and will generate data/reports for regulatory submissions. 

    Responsibilities

    • This role also performs, coordinates and/or leads analytical method development/validation and release/stability testing of drug products to generate documents for regulatory submissions
    • Job duties include developing/preparing protocols and detailed project working plans, conducting chemical tests as defined in protocols or test methods, processing and analysis of data, troubleshooting and problem solving, and drafting study reports
    • The Senior Analytical Development Chemist should work with minimal direction from Management, independently manages technical projects, and provides coordination / direction to the work of other employees as assigned
    • Take part in the planning, implementation and successful completion of all assigned projects in a timely fashion ensuring consistent high quality and using innovative / novel approaches.  These projects may include but are not limited to:
      • bulk drug characterization, developing quantitative specifications and test methods for bulk drugs, dosage forms impurities/degradation products and related substances
      • technology transfers
      • stability indicating assays; planning & implementing stability programs on both bulk drugs and/or dosage forms as per FDA/ICH guidelines  
    • Perform analytical research to support developmental studies for the successful development of new and generic drugs/products and generate data/reports for use by the client pharmaceutical companies as a part of their regulatory submission, such as IND, NDA, ANDA
    • Demonstrate the ability to successfully handle several projects simultaneously
    • Reviews lab notebooks and data generated by other team members 
    • Provide guidance to assigned technicians
    • Provides timely communication of experimental results to the Director on specific projects and if required interact with the clients/customers in a very professional, ethical and responsive manner
    • Assist the Director with evaluating and implementing new technologies
    • Comply with all relevant CGMP regulations and guidelines during carrying out of assigned studies, data analysis, interpretation and proper documentation
    • Other projects or activities as assigned by Management.

    Skills / Qualifications

    M.S in Chemistry with a minimum of five years relevant experience in pharmaceutical or related industry; or B.S. in Chemistry with a minimum of seven year relevant experience in pharmaceutical or related industry.  Other requirements include:

    • Industrial experience in developing and validating chemical test methods for pharmaceutical and/or biotechnology products
      HPLC (including reversed phase, ion exchange and size exclusion chromatography), GC, FTIR, UV/Vis, Electrophoresis, and other USP instrumental and Wet chemistry methods used in pharmaceutical and biotechnology  quality control
    • Demonstrated performance in leading technical projects and personnel
    • Demonstrated technical writing skills (protocols, reports)

    Company Overview

    We are Element, one of the fastest growing testing, inspection, certification and calibration businesses in the world.

     

    We deliver critical services in Materials Testing, Product Qualification Testing, Certification, Device Calibration and Advisory Services to the Aerospace, Oil and Gas, Transportation, Industrials, Fire and Building product, Infrastructure and other leading sectors, where failure in service is simply not an option.

     

    Everything we do helps our customers to build better products; get their products to market on time; save them time and money; and minimize the risk associated with product development and production.

     

    Our mission is simple: to be the best testing partner in the world and together we strive towards a common vision of becoming the world’s most trusted testing partner.

     

    We have four values that we strive to live by every single day.

    • Safety - We keep our colleagues and visitors safe
    • Integrity - We act honestly and fairly to do the right thing
    • Excellence - We set new standards of excellence in everything we do
    • Partnership - We work together for the benefit of our customers

    When combined with our mission and vision, the ethos this creates, enables Element to deliver one thing. CERTAINTY.  We exist to help make certain that the materials and products we test, inspect, certify and calibrate for our customers are safe, quality, compliant and fit for purpose.

    Diversity Statement

    At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.

     

    All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: race, colour, age, religion, gender, national origin, disability, and/or protected veteran status, or other characteristics in accordance with the applicable governing laws.

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