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Lilly TSMS Sr Manager in Carolina, Puerto Rico

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.

The TSMS Sr Manager is primarily responsible for the development of the employees with the purpose of ensuring the reliable and compliant manufacturing of drug product. Additionally, partner to influence and implement within the TS/MS organization and across functional disciplines the TS/MS cleaning and Product Protection Control Strategy (PPCS) agenda, Business Plan priorities and GMP Quality Plan objectives. The candidate will be responsible to lead the site cleaning validation and product protection control strategy programs and ensure compliance with all applicable regulations and corporate standards. Lead technical team to assess impact to cleaning and PPCS programs during technology transfer of new dry products to the manufacturing site and implementation of continuous improvement initiatives. Responsible for technical documentation and evaluation of preventive / corrective actions applying scientific expertise on equipment, facilities, computer systems and manufacturing operations. Participate in the design and execution of Cleaning, Bioburden Control Strategies and Validation exercises. He/she will be responsible to guide the team to carry out investigations, identify CAPA plans and present them to deviation board. Maintain an effective collaboration with secondary loop personnel, TSMS laboratory, other functions, and other Lilly manufacturing sites to identify best practices for replication. Ensure data integrity and verification procedures are followed. Document work and learning in official documentation systems such as: process flow document, manufacturing instructions, SOPs, technical reports, etc.

Basic Qualifications

  • Bachelor or Masters Degree or PhD in scientific disciplines of Microbiology, Chemistry , Chemical Engineering or Pharmacy is required.

  • A minimum of five (5) years of experience in a cGMP manufacturing environment in relevant industrial experience, solid dosage forms, validation, technology transfer, technical support, cleaning validation, project management is required.

  • Supervision skills is required

  • Knowledge of cGMPs

  • Strong technical writing and presentation skills.

  • Strong process data analysis using statistical tools.

  • Excellent interpersonal and leadership skills that promote engagement, people development and teamwork within cross-functional environment.

Other Requirements

  • Fluency in English and Spanish (read/write) is required.

  • Teamwork oriented

  • Influence skill.

  • Demonstrated leadership skills.

  • Excellent people management skills.

  • Excellent communication skills, both oral and written, at all levels (with both internal and external resources).

  • Work with multiple assignments at a time and within an environment with distractions

  • Able to work irregular hours, rotating shifts, weekends, holidays if necessary.

  • Self-starter, self-directed

  • Project management skills.

  • Ability to coordinate and accomplish multiple tasks.

  • Extensive technical knowledge in the systems required to support the pharmaceutical manufacturing of solid oral products.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.

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).