Johnson & Johnson
Associate Scientist
Position Summary
Global Clinical Release & Stability is a department of Pharmaceutical Development and Manufacturing Sciences - Analytical Development (PDMS-AD). The department is responsible for Tox release testing, Clinical release and stability testing for drug substance and drug product, and Stability Lifecycle management. The Clinical release & stability department in Cork, Ireland, is responsible for the analytical testing for biotechnology products.
Main duties and responsibilities
Perform analytical and/or biochemical tests according to international pharmacopeial, regulatory and corporate standards in a timely and organized fashion.
Generate data and interpret results within required due dates for release and stability.
Perform data review.Keep up to date with existing and new SOPs and official documentation.
Contribute to proper use, calibration and maintenance of laboratory equipment.
Perform investigations, where required, for deviations, Out-of-Specification Results etc.
Perform sample management activities.
Coordinate receipt and distribution of samples throughout the laboratories.
Perform other duties as designated by Laboratory Management.
Develop subject matter expertise on assigned analytical techniques.
Independently write/revise SOPs or other official documentation and reports, when required.
Execute independently assigned projects.
Train / coach other analysts and new personnel.
Education and Experience/Competencies
A Bachelor Degree or Masters Qualification in Chemistry, Biology or a related field with knowledge of analytics and/or stability.
At least 2-3 years of industry experience.
Practical analytical laboratory experience in a GMP environment is required.
A good basic knowledge of some of the following techniques (SEC-HPLC, ELISA SDS-PAGE, Capillary SDS, Residual Moisture, pH, Turbidity and or Bioassays) is an advantage.
A knowledge of Sample Management is an advantage.
Experience with LIMS systems is desirable. High attention to detail.
Analytical skills to troubleshoot laboratory issues are an asset.