Lilly Associate Director TSMS 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.
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) is responsible for managing the activities of TSMS personnel supporting the oversight of Insulin Active Pharmaceutical Ingredient (API) manufactured within Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing site. The Assoc. Director TSMS must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives.
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, 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
Define strategic direction and provide oversight for setting the technical agenda to improve process control, yield, and/or productivity for all products within the site portfolio.
Ensure adequate oversight and technical excellence for investigations and complaints.
Ensure adequate oversight for technical projects to improve process control, capacity, yield, quality
Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas.
Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.
Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization.
Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field.
5+ of experience in pharmaceutical manufacturing environment in any of the following associated disciplines: TSMS, Production, Quality Assurance, Quality Control, Engineering, Project Management, Development, Procurement.
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
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
Minimal travel (<10%) may be required
Some off-shift work (night/weekend) may be required to support 24/7 operations
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Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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).