Scientist/ Sr Scientist- Bioprocessing (Downstream) Full-time

Bioprocess Scientist – Technical Services/Manufacturing Sciences

The Bioprocess Scientist TS/MS will be responsible for providing technical support for the introduction of manufacturing processes into the operations/manufacturing environment in Limerick, in addition to the development, commercialisation, technology transfer of new processes into the facility. The position will be focused on protein purification (Downstream) science and technology. The successful applicant will build a deep technical expertise in their area of responsibility and demonstrate strong data-driven decision-making and problem-solving capabilities. They will also work to continuously improve process performance by implementing new technologies and process improvements. They will maximise the benefits of a Digital Plant to gain in depth knowledge of the process through data analytics and Process Analytical Technology.

Key Responsibilities

• Have an in-depth knowledge of the science behind the molecule and the biotech manufacturing processes. Understand molecule-specific control strategy and basis of specifications and critical attributes.
• Work with the development organisation to ensure a well-understood, robust and fit-for-purpose process control strategy is developed and transferred
• Understand purpose and capability of each Unit Operation and the impact of equipment on the process, with adept process monitoring skills to ensure process remains in control
• Interpret complex technical challenges to design and/or execute experiments to enhance understanding of the manufacturing processes, increase process robustness and productivity and to aid manufacturing investigations.
• Work as part of cross-functional teams, and establish partnerships with applicable functions, operations and TSMS Lab to understand interface between the science/engineering with the operations on the floor and bring deep technical expertise to the team.
• Understand basic statistical methodologies engage with Statisticians to assign specifications, validation acceptance criteria, tech transfer criteria, material sampling criteria, comparability assessments and analysis of batch data for summary reports and product reviews.
• Develop capability in use of statistical and programming software (e.g. JMP, Python, SIMCA) to apply a broad range of data science and statistical applications, such as, DoE, multivariate analysis, and statistical modelling.
• Understand integration of process parameter requirements with MES/electronic batch records to ensure all regulatory, compliance and process monitoring needs are captured in manufacturing electronic documentation.
• Identify process improvements and participate in implementation of Lean manufacturing initiatives
• Establish/qualify scale-down models of manufacturing processes
• Generate scientific reports and technical documentation
• Document and appropriately communicate aspects of work and learnings at internal and external fora (may include participation at scientific meetings)
• Understand and ensure compliance with safety, compliance, and regulatory expectations
• Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies
• Provide training and mentorship for new personnel

Attributes for the Role

• 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

Educational Requirements:

• PhD in Biochemistry, Cell Biology, Biotechnology, Microbiology, Analytical Science, Biochemical Engineering, or related discipline.
• MSc with relevant experience (>3 years' experience within the biopharmaceutical industry) will also be considered.

Work Environment:

• These are 8-hour day roles. As a manufacturing support function, the need for occasional evening or weekend support can arise.

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. 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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