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.
For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
The Associate Director – Technical Services/Manufacturing Science (TSMS) Visual Inspection is responsible for managing the activities of TSMS personnel supporting the oversight of those supporting the visual inspection of products manufactured within Indianapolis Parenteral Manufacturing. The scope for visual inspection includes technical support for all manual, semi-automated, and automated inspection processes, including associated defect classification, control strategies, validation strategies, and personnel qualification strategies. The Associate Director – TS/MS Visual Inspection must balance coaching a technical staff, prioritization and staffing for routine production support activities, and implementation of technical projects. The position requires working cross-functionally within the site, network, commercialization teams, and function to deliver on technical objectives, specific product business plan, and quality objectives.
Responsibilities:
- Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, defect classifications, personnel qualification strategies, control strategies, technical studies, etc.
- Performance management and development of staff.
- Partner within TSMS and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives
- Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits
- Technical review and approval for site quality documents, plans, validation related documents, and technical studies.
- Define strategic direction and provide oversight for setting the technical agenda to improve defect rates, defect detection capability, process control, yield, and/or productivity for all products within the site portfolio.
- Ensure establishment of critical attributes for high-risk materials and provide oversight for studies as needed to define critical attribute parameter limits.
- Manage Lilly and Vendor control strategies.
- Ensure adequate oversight and timeliness of periodic reviews of material specifications.
- Provide oversight and evaluation regarding the impact of changes to high-risk materials.
- Ensure adequate oversight and technical excellence for investigations and complaints.
- Ensure adequate oversight for technical projects with suppliers to improve process control, capacity, yield, quality and attribute measurement for high-risk materials.
- Ensure adequate oversight of suppliers to address complaints, process improvements, performance, corrective actions, and technical guidance with respect to Lilly requirements.
- Engage and influence Pharmaceutical Product Development groups concerning visual inspection processes related to new molecule entities during each stage of commercialization.
- Ensure adequate technical representation and engagement within site and network governance meetings to influence the broader product visual inspection technical agendas.
- Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.
Basic Qualifications:
- Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field.
- Minimum 5 years of experience in pharmaceutical manufacturing environment in any of the following associated disciplines: TSMS, Production, Quality Assurance, Quality Control, Engineering, Project Management, Development, Procurement.
Additional Skills/Preferences:
- Experience in Visual Inspection of injectable products preferred.
- Responsible for maintaining a safe work environment.
- Ability to influence and lead diverse groups.
- Influences complex regulatory, business, or technical issues within the site and function.
- Experience in statistics and stackable tolerance analysis.
- Technical leadership, administrative and organizational skills.
- Builds relationships with internal and external customers and partners.
- Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional.
- Demonstrated Project Management skills and ability to coordinate complex projects.
- Strong analytical and quantitative problem-solving skills.
- Ability to communicate and influence effectively across functional groups and stakeholders.
- Strategic thinking and ability to balance short term needs with long term business evolution.
- Enthusiasm for changes, team spirit and flexibility.
- Demonstrated ability to learn & apply technical/scientific knowledge.
Additional information:
- Some off-shift work (night/weekend) may be required to support 24/7 operations
- Some travel (up to 10%) may be required to support supplier oversight.
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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$118,500 - $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.
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