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 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 organizations
Manage 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:
5+ years of demonstrated experience aligning with delivery of and assuring cGMP compliance of a production operation.
Relevant industrial experience in dry operations technologies such as tablets and capsules manufacture focused on technical services and in any of the following disciplines such as Development, Manufacturing and or, Quality Assurance.
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 manufacturing
Strong leadership, interpersonal and teamwork skills, able to work effectively in a team environment
Good communication skills, especially attention to detail in written procedures and protocol development
Capability to work in a virtual and complex environment
Willingness to travel
Has 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.
Additional Information
Off hours may be necessary to support operations
Travel 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 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
$66,000 - $171,600
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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