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.

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 Responsibilities

Knowledgeable 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 agencies

Attributes for the Role

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-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)

Work Environment:

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

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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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