Job Title: Analytical Scientist III
Job Location: Boothwyn, PA.
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.
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; email@example.com.