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.
Senior Principal Bioprocess Scientist (Upstream) The Senior Principal Bioprocess Scientist (Upstream) will be responsible for providing technical support to introduce and sustain advanced upstream cell culture manufacturing processes at the next-generation bioprocessing site at Lilly Limerick, from startup through to routine operations. The successful candidate will drive technical leadership across the wider upstream bioprocess team and serve as a point of cross functional integration for the other operational and technical functions. The successful applicant must have a deep technical expertise in upstream bioprocessing and a strong skillset in data-driven decision-making and problem-solving capabilities. They will also work across the team to continuously improve process performance by implementing new technologies and process improvements throughout the novel upstream process. They will maximize 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 of upstream cell culture processes and understand the principles of a control strategy and the basis of specifications and critical attributesUnderstand purpose and capability of each upstream unit operation and the impact of equipment on the processServe as a technical leader for the wider process support team for process science, operational excellence and complianceWork 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 teamUtilize process monitoring tools to make data driven decisions to ensure process consistency and robustnessUnderstand 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 reviewsDevelop capability in use of statistical and programming software (e.g. JMP, SIMCA) to apply a broad range of data science and statistical applications, such as, DoE, multivariate analysis, and statistical modellingUnderstand integration of process parameter requirements with MES/electronic batch records to ensure all regulatory, compliance and process monitoring needs are captured in manufacturing electronic documentationIdentify process improvements and participate in implementation of Lean Manufacturing initiativesGenerate scientific reports and technical documentationUnderstand and ensure compliance with safety, compliance, and regulatory expectationsContribute to the authorship and review of regulatory submissions and responses to regulatory agenciesBasic Requirements: PhD or MSc in Biochemistry, Cell Biology, Biotechnology, Biochemical Engineering, or related discipline with >8 years' relevant experience within the biopharmaceutical industry.
Additional Requirements: Demonstrated technical capability with high productivityProven track record of curiosity with learning agilitySelf-starter with high initiative and data-driven approach to problem-solvingDemonstrated strong interpersonal skillsDemonstrated strong verbal and written communication skillsDemonstrated adaptability and flexibility to working in different environments, teams etc.Demonstrated ability to participate in and facilitate decision-makingWork Environment: These are 8-hour day roles. As a manufacturing support function, the need for occasional evening or weekend support can arise.
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