Senior BioProcess Scientist (Upstream)

Eli Lilly

Limerick, Ireland

The Senior Bioprocess Scientist will provide technical support for introducing and supporting advanced upstream cell culture manufacturing processes into the next-generation bioprocessing site in Limerick, from startup through to routine operations. As part of the Technical Services/Manufacturing Sciences department, the ideal candidate will possess technical expertise in upstream bioprocessing, along with strong data-driven decision-making and problem-solving skills. Additionally, they will leverage the advantages of a wholly digital plant to gain comprehensive process insights through data analytics and process analytical technology.

Key Responsibilities

Knowledgeable of the science of upstream cell culture processes and understand molecule-specific control strategy and basis of specifications and critical attributes;
Understand purpose and capability of each upstream unit operation and the impact of equipment on the process;
Provide technical support to the online process support team for process science, operational excellence and compliance;
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;
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;
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;
Generate scientific reports and technical documentation;
Understand and ensure compliance with safety, compliance, and regulatory expectations;
Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies.

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:

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

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