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.

Responsibilities

The TSMS Representative role provides the technical support and leadership required to achieve the reliable and compliant manufacture of the Dry Products External Manufacturing (Dry-EM).  The TSMS Representative works with the technical staff responsible for the development and delivery of programs for continuous process optimization and improvement. 

Key Objectives/Deliverables:

Understand the scientific principles required for manufacturing drug products, including the interaction of the formulation and equipment. Develop and steward operational control strategies.Serve as a technical leader and mentor for Scientists, Managers, and other disciplines.Maintain interface with the TS/MS function, development, customers, and contract manufacturing organizationsManage TS/MS technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, and/or productivity.Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc. Review/approve relevant technical documents, such as: Change Controls, Regulatory Submissions, Expert Opinions, Deviations, Validations, Tickets, Procedures, PFDs, etc.Remain current with all the regulations (global GMP expectations, regulatory expectations, health, safety, and environmental regulations)Provide support to internal and joint process teams.

Basic Qualifications

Education:Bachelor´s Degree or equivalent work experience in scientific disciplines of Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, Biochemistry, Organic Chemistry, Physical Chemistry, Bioanalytical Chemistry, Microbiology, Analytical Chemistry, Materials Science, or Engineering.Experience:Minimum of 3 years of demonstrated experience aligning with delivery of and assuring cGMP compliance of a production operation.Relevant industrial experience in any of the following disciplines such as Manufacturing, Quality Control, Quality Assurance, Advanced Project Management, Regulatory, Development, or Administration.Skills:Ability to represent Eli Lilly’s mission, policies and practices in a positive, professional, and ethical manner  A thorough understanding of cGMPs and drug product manufacturingStrong leadership, interpersonal and teamwork skills, able to work effectively in a team environmentGood communication skills, especially attention to detail in written procedures and protocol developmentCapability to work in a virtual and complex environmentWillingness to travelAppreciation for cultural diversity and inclusive leadershipHas experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools & principles

Additional Skills/ Preferences

Has experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools.Ability to work independently as well as part of a team.Ability to prioritize activities.Good judgment and flexibility.Language: English

Additional Information

Off hours may be necessary to support operationsTravel is possible, up to 30 %

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 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.

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