BioSpace
Principal Scientist – TS/MS Visual Inspection
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Responsibilities
The Principal Scientist - Visual Inspection will assume responsibility across the LKC manufacturing site in terms of ownership and harmonization of local control strategy that are implemented and executed at the site with regarding the Visual Inspection program. 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.
Key Objectives/Deliverables
- Serve as technical subject matter expert and program owner for all topics related to visual inspection supporting the Lilly Kenosha County site.
- Be responsible with respect to implementation of regulatory guidance (e.g. USP ), technology advancements, and understanding of how changes could impact Eli Lilly.
- Provide technical consultation regarding defect classification and visual inspection technique.
- Author, review, or approve technical documents, including personnel qualification strategies, control strategies, investigations, change controls, qualifications, procedures, defect classifications, 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.
- Provide technical support for non-routine investigations (e.g., deviations, complaints).
- Lead/participate in KNAPP studies, and/or operator training/qualification studies.
- Although not a supervisory role, technical leadership, and the ability to train/mentor others and cross functionally influence are important in this role.
Basic Qualifications
- Minimum of bachelor's degree in science or engineering field
- 3+ years proven experience in visual inspection of pharmaceutical products
Additional Skills/Preferences
- Preferred 5+ 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.
- Build relationships with internal and external customers and partners.
- Proficiency in delivering highly sophisticated tasks and/or tasks that are highly cross-functional.
- Strong analytical and quantitative problem-solving skills.
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