Organization Overview
Lilly is designing and building a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Limerick facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-gen manufacturing technologies, and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.
Responsibilities
* The Senior Laboratory Analyst (Sr. Specialist - Analytical) key responsibilities shall include but shall not be limited to:
* Executing analytical procedures in accordance with current corporate specifications and cGMPs and for maintaining the relevant SOPs.
* Building / Maintaining QCL digital systems in collaboration with site and external Digital teams.
* Reporting results into a computer storage system (LIMS), as well as performing 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 recording 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 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.
Basic 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.
Additional Information
* Candidates must be able to travel for familiarization and training as required.
* May be required to work on a shift basis depending on production support needs. This can be further discussed at interview stage.
* Candidates must meet the minimum qualifications outlined in the Educational Requirements section.
* Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
* Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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