Visual Inspection Scientist - Advanced Therapies Manufacturing

Visual Inspection Scientist – Technical Services/Manufacturing Scientist (TS/MS)At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.Lilly recently opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply.The Visual Inspection Scientist – Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support to achieve the reliable and compliant manufacture of gene therapy drug product to predetermined global quality standards via a detailed set of manufacturing instructions and procedures. In this role, the successful candidate provides day-to-day technical support to the visual inspection program, supporting inspection qualification, defect classification, and process monitoring while working cross-functionally with Operations, Quality Assurance, and Engineering. This person interacts daily with a wide variety of stakeholders internally and externally.The mission of TS/MS is to provide scientific leadership and technical support for manufacturing to make medicine today and tomorrow.Key Objectives/Deliverables:Understand the scientific and quality principles that govern the visual inspection of drug products, including how the product, equipment, aseptic processes, and container closure systems influence inspection outcomes and defect presentation.Provide day-to-day technical support to the visual inspection process so that inspection is performed reliably, consistently, and in compliance with applicable procedures and quality standards.Support the qualification and ongoing performance of inspection personnel and equipment, including inspector qualification, defect classification, and review of inspection results, escalating complex questions to Quality or senior TS/MS as needed.Support the maintenance of visual inspection tools and materials, such as test kits, practice kits, and defect libraries, in partnership with Quality Assurance.Help monitor visual inspection performance and quality metrics, identify trends, and support timely and appropriate responses to process variability.Prepare, review, and provide technical support for visual-inspection-related studies and documentation, such as procedures, work instructions, deviation investigations, change controls, and monitoring reports.Participate in continuous improvement, deviation investigations, and cross-functional projects related to visual inspection, and continue to develop visual inspection knowledge and technical capability over time.Train, coach, and mentor operators, statistical sorters, and inspectors on inspection technique and defect classification, and support the visual inspection practice, job shadowing, and training program.While primarily focused on visual inspection, provide technical support to other areas of the TS/MS and manufacturing organization and perform other related duties as assigned, based on site priorities and business needs.Basic Requirements:Bachelor's degree in scientific disciplines of Biochemistry, Chemistry, Microbiology, Pharmacy, Engineering or related scientific field.3+ years of experience in manufacturing, preferably within pharmaceutical manufacturing environment.Must pass a vision exam and be free of color blindnessMust be able to perform tasks requiring near?vision clarity equivalent to 20/20 at close range, with or without corrective lensesQualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.Additional Preferences:Clear understanding of current Good Manufacturing Practices (cGMPs).Computer skillsTeamwork and interpersonal skillsPreferred experience in visual inspection of pharmaceutical products, including familiarity with defect classification, inspection qualification, or statistical sort.Ability to influence and communicate to diverse groups on, technical or business issues within the site and function.Ability to train, coach, and mentor operators, statistical sorters, and inspectors on visual inspection technique and defect classification.Experience in statistics and stackable tolerance analysis.Builds relationships with internal and external customers and partners.Proficiency in delivering complex tasks and/or tasks that are cross-functional.Ability to manage multiple tasks and priorities.Demonstrated Project Management skills and ability to coordinate complex projects.Strong analytical, quantitative problem solving and decision-making skills.Strategic thinking and ability to balance short term needs with long term business evolution.Additional Information:Responsible for maintaining a safe work environment at all times.Occasional off-shift availability may be needed to respond to operational issues; this is expected to be limited and, where possible, arranged in advance.Minimal travel required.Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (View email address on click.appcast.io), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $67,500 - $173,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.