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.

Position Brand Description:

The TS/MS Product Steward is a position that supports, develops, and implements a technical agenda, and is responsible for providing technical leadership across all processes and products within the Indianapolis Device Assembly and Packaging (IDAP) site. Primary objectives include maintaining the validated state of all IDAP processes, establishing metrics to ensure a state of capability and control, harmonization of control strategies across process teams, improvement of the processes, and serving as an escalation point for day-to-day operations. The role is also responsible for technical leadership of commercialization activities at the site. This role is expected to serve as a mentor to other employees within the TS/MS team and other functions within IDAP.

Key Objectives/Deliverables:

Own Tech Transfer and Validation strategy for the manufacturing siteParticipate in equipment/product/format commissioning, qualification, and validation activitiesRepresent TS/MS team to the IDAP Site Lead teamProvide technical support to non-routine (e.g., deviation, complaint) investigationsPrepare, review, and approve, as required, relevant technical documents such as: annual product reviews, change controls, regulatory submissions, deviations, validations, procedures, PFDs, PFMEAs, etc.Monitor process control and capabilityLead technical projects to improve process control and/or productivityDrive technical consistency across process teamsServe as interface with upstream suppliers and global device/drug product networksServe as a technical mentor for TS/MS, engineers, managers, and other disciplinesCollaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in IDAP

Minimum Requirements:

Bachelor's degree or higher in engineering, science, or related field5+ years of experience in a manufacturing organizationClear understanding of cGMPsDemonstrated successful leadership/mentorship of cross-functional teams

Additional Preferences:

Experience in multiple functions within a manufacturing site (operations, engineering, quality, etc.)Previous experience in TS/MS or technical function within manufacturing organizationPharmaceutical manufacturing experienceRoot Cause Investigation ExperienceDemonstrated technical writing skillsGood written and oral communicationsGood teamwork and interpersonal skillsResponsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Other Information:

Some travel