Expert Specialist

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Job Description

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.

We are seeking a Laboratory Analyst (Expert Specialist) in our Cell Based Assay Quality Control area to support our new Biologics Manufacturing Facility at Raheen Co. Limerick.

Key Responsibilities

- Executing analytical procedures in accordance with current corporate specifications and cGMP’s and for maintaining the relevant SOP’s.

- Maintenance and cultivation of cells used in the Cell Based Assay Labs.

- 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 behaviour 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 cell/virus banks, reagents 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.

Pre-Requisites (Includes experience, qualification etc.)

- Hons BSc in Virology, Microbiology, Molecular Biology, Cellular Biology, Biochemistry, Biology or related field with a minimum of 5 years GMP/GLP experience.

- Deep technical expertise in Virology and Bioassay techniques with emphasis on techniques to support various types of IVV Assays, cell culturing, contamination control etc.

- Understanding of haemagglutination, hemadsorption and cytopathic effects.

- Highly Proficient in the use of multiple instrument platforms (e.g. Vicell, Molecular Devices, etc.) and software applications (e.g. SoftMax Pro, LIMS / LES systems, etc).

- Excellent attention to detail in all aspects of the work.

- Detailed understanding of Data Integrity and its applications in a Digital Laboratory.

Additional Skills/Preferences

- Highly competent with computer systems.

- Experience working in cross functional teams and proven ability in decision making.

- Demonstrates 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.

Others

- 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.

- Candidates must meet the minimum qualifications outlined in the Educational Requirements section to be considered for the role.

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 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.

#WeAreLillyUKandIreland

#J-18808-Ljbffr