Lilly Principal Scientist – Visual Inspection Steward-TS/MS in Indianapolis, Indiana
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.
The mission of Technical Services/Manufacturing Sciences (TS/MS) is to provide scientific leadership and technical support for manufacturing to make medicine today and tomorrow. The Sr. Principal Scientist-Visual Inspection Steward-TS/MS is a key member in a cross-functional team who provides technical leadership for inspection operations and projects involving existing and new inspection processes/technology.
The Indianapolis Parenteral Manufacturing Sr. Principal Scientist-Visual Inspection Steward-TS/MS will assume broad responsibility across the manufacturing site in terms of ownership and harmonization of local control strategy that are implemented and executed at the site. The role will regularly interact with peers within the network and in Global TS/MS to share learning and ensure strategies are in line with technical, quality, and regulatory guidance, while supporting business expectations. The Sr. Principal Scientist-Visual Inspection Steward-TS/MS will also own technical capability development of other technical staff at the sites to ensure capabilities are in effect to meet business objectives.
Serve as technical subject matter expert and program owner for all topics related to visual inspection processes supporting the Indianapolis Parenteral Manufacturing site.
Be responsible and influential with respect to implementation of regulatory guidance (e.g. USP <1790>), technology advancements, broader external trends and understanding of how changes could impact Eli Lilly
Provide technical consultation to technical staff regarding defect classification and visual inspection technique
Author, review, or approve technical documents, including personnel qualification strategies, control strategies, investigations, change controls, expert opinions, qualifications, procedures, defect classifications, personnel qualification strategies, control strategies, technical studies, etc.
Interact with regulators, customers, or other outside partners on business issues or in support of internal and external agency audits
Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability
Own the development and implementation of process improvements to improve process control, yield, and/or efficiency
Technical writing and communication skills are used daily and the ability to optimally communicate and transfer knowledge to all levels of the organization is crucial.
Although not a supervisory role, technical leadership, and the ability to train/mentor others and cross functionally influence are important in this role.
- Minimum of bachelor's degree in science or engineering field
Preferred 10 years proven experience directly supporting pharmaceutical manufacturing or quality, with experience in visual inspection of pharmaceutical products.
Ability to influence and communicate to diverse groups on sophisticated regulatory, business, or technical issues within the site and function
Responsible for maintaining a safe work environment
Experience in statistics and stackable tolerance analysis, ANSI Standards
Builds relationships with internal and external customers and partners
Proficiency in delivering highly sophisticated tasks and/or tasks that are highly cross-functional
Demonstrated Project Management skills and ability to coordinate sophisticated projects
Strong analytical and quantitative problem solving skills
Critical thinking and ability to balance short term needs with long term business evolution
This position is tech ladder approved (P4-R+).
This position will be in Indianapolis, but could require some travel, less than 10%; including international
This position is day shift, Monday-Friday, with off hours support needed, by request.
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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).