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.
Research Advisor - Technical Services/Manufacturing Sciences The Research Advisor TS/MS will provide technical stewardship across the new Lilly Limerick Next Generation Bioprocessing facility. The successful candidate will be an expert in all aspects of the mammalian cell drug substance manufacturing platform. This role will have accountability for up- and downstream processing and requires experience and a deep knowledge of cell culture, contamination control and purification and filtration processes. The successful applicant will have experience with regulatory guidance and a familiarity with relevant strategies. They will have a strong skillset in data-driven decision-making and problem-solving capabilities, working continuously to drive 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. This role is for a cross-functional technical leader and is expected to set the standards for scientific curiosity and technical rigor for the site.
Key Responsibilities: Provide mentorship and scientific expertise to TS/MS bioprocess and laboratory scientists for process monitoring, trending, and analyzing production data. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations. Drive solutions to complex situations with impact across the site and functions.Understand and perform all job responsibilities in compliance with safety and regulatory expectations and bring experience and knowledge of cGMP requirements to the role.Represent the site technically across the broader manufacturing network including other drug substance sites, drug product sites, global functions, and process research and development. Review and approve annual product review and global product assessment.Partner with site leadership to ensure technical agendas are developed, implemented, and managed compliant with all regulatory expectations and in alignment with business needs.Mentor scientists, engineers, and operations staff and support troubleshooting. Anticipate and resolve key technical or operational problems with impact across all functions. Communicate issues in a timely manner. May lead complex process-related investigations and assess technical impact.Closely partner with the quality assurance and quality control functions to provide technical oversight of the control strategy and ensure manufacturing processes remain in a state of compliance.Author technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies.Own or assist in the implementation of large process-related change controls with greater risk, resource, and financial requirements or complexity.Support development of strategy for regulatory submissions and the creation of related documentation.Excellence in technical writing and oral communication skills with the ability to effectively communicate and transfer knowledge to all levels of the organization.Work with scientists and engineers to ensure successful process knowledge transfer to the manufacturing staff on the production floor and assist in process-related training of manufacturing staff.Support the PAT and data science programs to ensure alignment between program execution, process scientists, and control strategies.As required, design laboratory experiments in support of process troubleshooting and/or continuous improvement and execute or coordinate execution in outside laboratories. Help to define and implement medium to large continuous improvements to manufacturing processes.Work with Manufacturing to support the start-up and validation of the new facilities, process equipment, and products during technology transfer. Help to define, implement, and own control strategies for new products.Attributes for the Role: Demonstrated technical acumen and high productivityStrong proclivity for technical leadership, teaching, and mentoringProven track record of curiosity and 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 fast-paced, dynamic manufacturing environmentsDemonstrated ability to participate in and facilitate decision-makingEducational Requirements: PhD or MSc in Biochemistry, Cell Biology, Biotechnology, Biochemical Engineering or related discipline with relevant experience (>12 years' experience within the biopharmaceutical industry)
Work Environment: These are 8-hour day roles. As a manufacturing support role, the need for occasional evening or weekend support can arise. Occasional travel may be required.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to helping individuals with disabilities 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 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.
#WeAreLilly
#J-18808-Ljbffr
