Job Title: Analytical Scientist III

Job Location: Boothwyn, PA.

Job Summary:

Analytical Scientist III conducts chemical analyses and experiments to support analytically the method improvement, development, validation, and transfer activities for drug development. Specific duties will include:

  • Support formulation development, process development and manufacturing;

  • Conduct Material characterization and physical testing;

  • Develop, improve, and validate analytical methods and/or verify compendial test methods;

  • Perform support to R&D for development, validation of process improvements, and technology transfer;

  • Test and analyze raw materials, in-process samples, toxicology samples and products to determine stability, purity and other characteristics;

  • Follow analytical test methods, compendial methods or experimental procedures and SOP’s;

  • Document test results in laboratory notebook, in real-time, and communicates status of test results to supervisor;

  • Maintain control of all project related samples submitted to the laboratory;

  • Initiate documentation process, compile data into report form and authors reports;

  • Perform housekeeping to assure the laboratory is continuously maintained in a safe and orderly condition;

  • Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Comply with all company and site policies and procedures

  • Coordinate responsibilities and work in an efficient manner to assure accurate and timely data reports;

  • Consult and work with supervisor regarding any issues with sample preparation, instrument performance, data acquisition and analysis as it applies to data integrity and accuracy;

  • Operate analytical equipment as needed and execute protocols for validation of new equipment and products;

  • Review and write SOP’s and other lab documents as necessary;

  • Author analytical methods, method validation protocols and reports;

  • Calibrate, troubleshoot and perform maintenance and repair of laboratory instrumentation.

  • Minimum requirements:

    Master’s degree in Chemistry, or related field, or foreign degree equivalent plus 2 years of industrial pharmaceutical laboratory experience.

    The experience (which may be gained concurrently) must include:

  • 2 years of experience with HPLC, UPLC and dissolution apparatus;

  • Demonstrated knowledge of experiment documentation, operation and basic troubleshooting of analytical instrumentation including HPLC, UPLC, dissolution apparatus, and laboratory data collection software such as Empower;

  • Demonstrated knowledge of GMP, GLP, and ICH guidelines;

  • Experience working with wet chemistry and compendial tests including USP, NF and EP.

  • To apply send resume and letter of application detailing experience to Jenne’ Johnson, HR Generalist, QS Pharma LLC, 3 Chelsea Parkway, Boothwyn, PA 19601;