Lilly Agile - PLM Data Steward in Bengaluru, India
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 35,000 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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The Synthetic Molecule Design and Development (SMDD) Organization within Eli Lilly and Company is an integrated drug development organization, spanning across drug discovery through early phase development.
The vTeam, a virtual CMC product development team within the SMDD organization, is looking for a Product Lifecycle Management (PLM) Data Steward that has a strong technical depth in Information Technology data management, and the willingness to promote a collaborative, team-based approach to problem solving. The candidate will have a strong fundamental working knowledge of the Agile PLM system, along with the capabilities and values it provides, and demonstrated the ability to maximize and apply these skills within the vTeam.
Agile is an Oracle based PLM data system designed to manage the entire lifecycle of products from the ideation phase of initial requirements-gathering through to the design, prototyping, production, certification, customization, and Quality.
Expectations for the Agile PLM Data Steward:
Design, develop, and apply data requirements, workflows, and metrics within the Agile software to support early phase synthetic molecule design and development
Contribute to vTeam operational effectiveness by enabling full utilization of the Agile software to speed early clinical product development and supply chain
Promote general research and development effectiveness and productivity enhancement through information monitoring and metrics from within the Agile system
Demonstrate the ability to work both independently and remotely as part of a product development team consisting of Chemists, Engineers, Formulation Scientists, Project Managers, and Quality Assurance
Be an advocate and thought leader for data, educating the vTeam and/or Contract Partners (CP) on Agile capabilities and functionality, as well as, keeping a pulse on new best practices and technology
Assure quality and trust in the data, create standard definitions for the organization to follow, and maintain a consistent use of data resources across the vTeam
Be a trusted resource, aligning data integrity with the Quality System and regulatory requirements
Have a working knowledge of the pharmaceutical industry as it relates to the overall product life cycle
The PLM data steward will oversee seven key responsibilities:
Define the data and identify assets within data object domains. Ensure there are no conflicts with other data elements.
Create processes and procedures to monitor adherence. This includes establishing internal policies and standards—and enforcing those policies.
Maintain quality of the data using customer feedback, quality system expectations, regulatory requirements (data integrity); internally reporting metrics; evaluating and identifying issues; and coordinating and implementing corrections regularly.
Optimize workflows and communications.
Monitor data usage to assist teams , share best practice trends in data use, and provide insight into how and where teams can use data to help in day-to-day decision-making.
Ensure compliance and security of the data . Data stewards are responsible for protecting the data—while providing information on potential risks and offering regulatory guidance.
Training . Help set-up and train vTeam personnel and/or Contract Partners in the use of the Agile PLM system and function as a SME to troubleshoot issues.
B.S./M.S. in Computer Sciences/Information Technology with 2-5 years of Product Lifecycle Management (PLM) experience related to pharmaceuticals, devices, electronics, software and/or automotive/aerospace product development.
Delivered innovative solutions across the value chain in pharmaceutical product development from ideation to development to material supply and distribution.
Have a proven history of providing consulting services on design, implementation, and management of product lifecycle management solutions
Brought innovative thinking to the workplace and used it to improve knowledge management systems, business processes and interactions
Experience working in an GxP environment, preferably Pharmaceutical or Medical Device
Successfully worked in a team environment via a remote setting
Limited international travel (2 – 4%) may be required
Work hour flexibility to accommodate collaboration across multiple time zones
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 ( LillyRecruitingCompliance@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.