Process Analytical Technology

4 weeks ago

Limerick, Ireland Lilly Full time

We’re looking for people who are determined to make life better for people around the world.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Owing to the continuous growth of our Monoclonal pipeline of products, Eli Lilly & Company has invested in a new facility in Ireland, Lilly Limerick. To support this exciting new investment and meet the requirements of a safe and successful start-up, we are eager for talented individuals to join our team(s) and contribute to establishing Lilly Limerick as a reliable supplier of our innovative medicines and our goal of making a difference to people’s lives.

If you are looking for a challenging, rewarding career and feel you meet the requirements listed below we would love to consider you for a role at Lilly, Limerick.

PAT Scientist - Technical Services/Manufacturing Sciences

The Process Analytical Technology (PAT) scientist will support efficient on-line and in-line analytical instrumentation in biotech manufacturing to support continuous support and knowledge management. The successful candidate will be responsible for implementation of PAT technology for facility startup and subsequent multivariate analysis, maintenance, and continuous improvement of the site’s PAT equipment and data management infrastructure. The PAT scientist will work closely with engineering, automation, MES, and process teams to achieve its objectives. The selected candidate will be responsible for a holistic review of the PAT data, along with the development, validation, and enhancement of methods. They will also validate computer systems and author as well as execute protocols and procedures that are well-defined. The PAT scientist will develop and utilise deep technical expertise in analytical technology and demonstrate strong data-driven decision-making and problem-solving capabilities. They will also work to continuously improve process efficiency by implementing new technologies and process improvements. The successful candidate will maximize the benefits of a Digital Plant to gain in depth knowledge and process insight through data analytics and Process Analytical Technology.

Responsibilities:

Seek to understand the scientific principles for manufacturing intermediates and bulk drug substances, including the interaction of the science and equipment. Act as Subject Matter Expert (SME) on all PAT equipment and associated data management pipelines and infrastructure. Creates, revises, or reviews documents such as: SOPs, protocols and work instructions. Work as part of cross-functional teams, and establish partnerships with applicable functions (operations, TSMS, engineering) to understand interface between the science/engineering with the operations on the floor and bring deep technical expertise to the team. Troubleshoot PAT instrumentation and methods as issues arise Develop and utilize expertise in multivariate statistical process control (MSPC) and SIMCA-online to develop and refine models that drive our real-time monitoring systems. Engage and influence the efficiency and effectiveness of our operations. Lead investigations by analyzing the data to identify anomalies, investigate their causes, and propose solutions. Leverage process analytical technology (PAT) data to identify opportunities for process optimizations and continuous improvements. Understand the integration of PAT equipment requirements with MES/electronic batch records to ensure all compliance and data monitoring needs are captured in manufacturing electronic documentation. Support other core PAT activities (e.g. preventative maintenance planning, system upgrades, periodic review, change management, deviation management, external agency/internal inspections).

Basic Requirements:

Bachelor’s, Masters or PhD qualification in relevant scientific discipline such as Engineering, Biology, Chemistry, Microbiology, etc. Demonstrated experience in analytical instrumentation techniques (e.g. Raman) Minimum of 4 years GMP manufacturing experience

Additional Preferences:

Demonstrated technical capability with high productivity Proven track record of curiosity with learning agility Self-starter with high initiative and data-driven approach to problem-solving Demonstrated strong interpersonal skills Demonstrated strong verbal and written communication skills Demonstrated adaptability and flexibility to working in different environments, teams etc. Demonstrated ability to participate in and facilitate decision-making Demonstrated problem solving skills Proficient in English

Additional Information:

Minimal travel - occasional travel may be required for training, conferences etc.  These are 8-hour day roles. As a manufacturing support function, the need for occasional evening or weekend support can arise.

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.

#WeAreLilly

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