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