Scientist/Sr Scientist - Bioprocess Downstream

Scientist/Sr Scientist - Bioprocess Downstream

Eli Lilly

Limerick, Ireland

Overview:

The Bioprocess Scientist is responsible for providing technical support for introducing and supporting advanced downstream manufacturing processes into the next-generation bioprocessing site in Limerick, from start-up through to routine operations. As part of the Technical Services/Manufacturing Sciences department, the ideal candidate will possess deep technical expertise in downstream bioprocessing, along with data-driven decision making and problem-solving skills. Additionally, they will leverage the advantages of the digital plant approach to gain comprehensive process insights through data analytics and process analytical technology.

Key responsibilities:

• Knowledgeable of the science of downstream bioprocesses and understand the molecule-specific control strategy and basis of specifications and critical attributes;
• Work as part of a cross-functional team at the interface between quality assurance, operations and engineering to bring deep technical expertise and scientific rigor to the team;
• Utilize process monitoring tools to make data driven decisions to ensure process consistency and robustness;
• Generate scientific reports and technical documentation, in addition to contributing to the authorship and review of regulatory submissions and responses to regulatory agencies;
• Understand basic statistical methodologies to 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;
• Understand integration of process parameter requirements with MES/electronic batch records to ensure regulatory, compliance and process monitoring needs are captured in manufacturing electronic documentation.

Attributes for the role:

• Demonstrated technical capability with high productivity;
• Self-starter with high initiative and data-driven approach to problem solving;
• Proven track record of curiosity with learning agility;
• 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:

• BSc or MSc in Biochemistry, Biology, Biotechnology, Biochemical Engineering or related discipline with relevant experience (>2 years’ experience within the biopharmaceutical industry).

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