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 Principal/Senior Principal 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 In-depth knowledge of the science of downstream cell culture processes and understand molecule-specific control strategy and basis of specifications and critical attributes.Understand purpose and capability of each downstream unit operation and the impact of equipment on the process.Provide technical expertise 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 and 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: Bachelors, Masters, or PhD qualification in relevant scientific discipline such as Engineering, Biology, Chemistry, Microbiology, etc.Minimum of 5 years' experience in 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.
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