Downstream Bioprocess Scientist - Technical Services/Manufacturing Sciences

  • Limerick
  • Lilly
We’re looking for people who are determined to make life better for people around the world.The Downstream Bioprocess Scientist - TS/MS will be responsible for providing technical support for the introduction of manufacturing processes into the downstream operations/manufacturing environment in Limerick through the startup and into routine manufacturing operations. The successful applicant will have technical expertise in downstream bioprocessing and experience in 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 maximize the benefits of a digital plant to gain in depth knowledge of the process through data analytics and process analytical technology.Key ResponsibilitiesKnowledgeable of the science of downstream cell culture processes and understand molecule-specific control strategy and basis of specifications and critical attributesUnderstand purpose and capability of each downstream unit operation and the impact of equipment on the processProvide technical support to the online 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 reviewsUnderstand 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 agenciesAttributes for the RoleDemonstrated 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-makingEducational Requirements:BSc or MSc in Biochemistry, Biology, Biotechnology, Chemical Engineering or related discipline with relevant experience (>2 years’ experience within the biopharmaceutical industry)Work Environment: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