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Lilly TSMS Floor Representative 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.

Organization Overview:

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.

Responsibilities:

  • Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.

  • Ensure that an accurate instruction set (tickets and procedure) and process flow document describe the process as performed and the control strategy for the discrete manufacturing steps.

  • Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.

  • Understand, justify, and document the state of validation (process, cleaning, sterility assurance, etc) with data that evaluate the capability of the manufacturing process to meet its stated purpose.

  • Prepare, review, approve, and provide technical support for preparation of relevant technical documents as required, such as change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, process flow documents, validation master plans, annual product reviews, etc.

  • Support and/or lead the development and implementation of process improvements to improve process control, yield, purity, and/or productivity.

  • Participate in development and implementation of process improvements including capital expansions and technical projects.

  • Work within or lead cross-functional teams to implement functional objectives and deliver on business plan and quality objectives.

Basic Qualifications/ Requirements

  • Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field.

  • Prefer 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:

  • Ability to influence diverse groups

  • Influences complex regulatory, business, or technical issues within the site and function

  • Responsible for maintaining a safe work environment

  • Experience in statistics and stackable tolerance analysis

  • Technical leadership, administrative and organizational skills

  • Builds relationships with internal and external customers and partners

  • Interacts with regulators, customers, or other outside stakeholders on business issues in support of internal and external agency audits.

  • 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

  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

  • Requires comprehensive business and technical knowledge/experience to improve products, processes, and services.

  • Makes decisions that impact a range of standard and non-standard operational, process, project, or service activities.

  • Gains support for ideas or positions on difficult issues.

  • Anticipates and resolves complex problems.

  • Drives solutions for products, processes, and services across a large business area.

  • May lead medium-scale projects or programs with moderate risks and resource/financial requirements.

  • Establishes key relationships with those outside of business area.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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. If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

#WeAreLilly

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