Senior Laboratory Analyst (Sr. Specialist - Analytical)
We are seeking a skilled Senior Laboratory Analyst to join our team in Limerick, Ireland. As a key member of our Next Generation Biotech Drug Substance Manufacturing Facility, you will play a critical role in the design and operation of our state-of-the-art manufacturing site.
Salary: €60,000 - €80,000 per annum
About the Role
The successful candidate will be responsible for executing analytical procedures, maintaining QCL digital systems, reporting results into a computer storage system, and qualifying analytical instruments. You will also be involved in deviation investigations, environmental health and safety procedures, and training other personnel.
Responsibilities:
* Execute analytical procedures in accordance with current corporate specifications and cGMP's
* Build / Maintain QCL digital systems in collaboration with site and external Digital teams
* Report results into a computer storage system (LIMS), as well as perform testing using automated systems
* Involved in the qualification of analytical instruments and in their routine maintenance
* Development, validation and verification of new methodologies, as part of new product introductions or process improvement activities
* Recognizing atypical assay behavior and normally encountered equipment failure
* Involved in deviation investigations and will record any errors encountered, as per procedures and training
* Following all relevant Environmental, Health and Safety procedures and involved in incident investigations as required
* Responsible for the maintenance of an inventory of chemicals and supplies used to perform analytical testing
* Assisting in the training of other personnel and as their level of skill develops, may be responsible for the full training of other Laboratory personnel
* Responsible for adhering to, and improving, where appropriate, safety procedures to protect their other personnel and company property
* Displaying a high level of integrity in the performance of their work
* Relating well to other people with whom they come in contact, both within and outside of the laboratory area
* Knowledgeable of general scientific methods and capable of learning and executing new techniques and instrumentation after appropriate training
* May also be requested to partake in or lead area or cross-functional continuous improvement projects e.g. Six Sigma or other appropriate methodology
Requirements
* Hons BSc in Analytical Sciences (Chemistry, Biochemistry, Microbiology) with a minimum of 3 years pharmaceutical experience
* Comprehensive knowledge of quality control operations with an emphasis on techniques such as immunoassays, quantitative PCR, chromatography, capillary electrophoresis and spectroscopy
* Proficiency in the use of multiple instrument platforms (e.g. Agilent, Beckman Coulter, Sciex, Molecular Devices, Applied Bioscience, etc.) and associated software applications (e.g. SoftMax Pro, Empower, Accuseq LIMS / LES systems)
Additional Skills/Preferences
* Excellent attention to detail in all aspects of the work
* Demonstrated understanding of Data Integrity and its application in a Digital Laboratory
* Highly competent with computer systems
* Experience working in cross functional teams and proven ability in decision making
* Demonstrated ability in critical thinking, data analysis, problem solving and experience in root cause analysis
* Strong organizational skills, including ability to follow assignments through to completion
* Self-motivated, positive and ability to work under pressure
* Demonstrates flexibility and adaptability to meet business needs
* Excellent interpersonal and communication skills (written and oral)
* Demonstrates a continuous improvement mind-set
* Demonstrated initiative – able to work proactively without direct supervision
* Demonstrated ability to implement changes in technology and business systems / processes