Tristan Kuhnert
Bloomington
Summary
Driven professional with proven success in both personnel and technical leadership utilizing established leadership theory and certifications in Manufacturing Engineering and Continuous Improvement. Expert in biopharmaceutical operations ranging in scale from clinical to large scale commercial manufacturing, experienced with process optimization and workflow enhancement while optimizing team culture to ensure operational success long term.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Lead Process Specialist - Radiopharmaceuticals
Eli Lilly
11.2025 - Current
- Analyze operational workflows to identify inefficiencies and implement process improvements.
- Collaborate with cross-functional teams to enhance project outcomes and streamline processes as the manufacturing process SME.
- Collaborate with external vendors to address problems identified in gap assessment and Continuous Improvement initiatives.
- Created and led Continuous Improvement initiatives within the production team.
- Serve as equipment expert and primary liaison between Engineering and Production.
- Production representative on the design team for our new Midscale Isolator to ensure alignment with our process and optimize functionality.
- Organize and execute training for new production technician.
- Organize work for members of the production team
- Assist in Tech Transfer of projects and scale up of clinical projects into commercial manufacturing.
- Assist in process development of projects.
Expert Production Technician
Eli Lilly
01.2025 - 11.2025
- Set up and operated manual and semi-automated processes for the synthesis, formulation, and aseptic filling of Lu-177 radioligand therapy Finished Dosage Form medication.
- Assisted with equipment qualification and PMs
- Implemented Continuous Improvement initiatives.
- Collaborated with team members to streamline production workflows and reduce downtime.
- Assisted in troubleshooting equipment issues to minimize operational interruptions.
- Assisted with process development of projects.
Filling Lead
Simtra Biopharmaceuticals
04.2023 - 01.2025
- Performed aseptic set up and operation of several RABS filling lines within an A/B environment.
- Vial, Prefilled Syringe, and Cartridge Finished Dosage Form filling.
- Physical and HMI program trouble shooting of process machinery.
- Assisted in process development for our new PFS Isolator that launched commercial operations in 2024.
- Led shift meetings, organizing work for operators on my team.
- Developed team members through organization and optimization of training plans, and skillset development for future career growth.
- Delivered performance metrics to upper management.
- Continuous training to ensure compliance with continually evolving industry standards and expectations.
- Led 5S initiatives within my team.
- Assisted with NCR Investigations.
- Advised Engineering on process and equipment improvements to optimize process flow.
Prep Operator
Baxter Pharmaceuticals
01.2022 - 04.2023
- Assembled of sterilized equipment.
- Set up and operated vial washers, stopper washers, and autoclaves.
- Led department in absence of the team lead.
- Performed batch record issuance through our Controlled Forms System.
- Issued equipment and materials through our CMMS and ERP systems.
Assembler
Cook Medical
05.2021 - 12.2021
- Established GDP and GMP fundamentals.
Education
CMfgE -
Indiana University Northwest
08.2025
Bachelor of Music -
Indiana University
Bloomington05.2024
Skills
- Lean Six Sigma
- Leadership Theory
- SCADA
- PLC Networking
- HMI programming
- Root Cause Analysis
- Continuous Improvement
- Process Machinery Troubleshooting
Certification
- Lean Six Sigma Black Belt (2025)
- Certified Manufacturing Engineer (2025) - an intensive program that addresses various topics in Manufacturing Engineering such as Process Improvement, QMS, CNC, manufacturing methods, electric and fluid mechanics, circuit design, cybersecurity, calibration, GD&T, MSA, prototyping, technical transfer, process/product development, material science, EHS, PLC networking and programming, ISO quality, automation, personnel management, and engineering mathematics.
Timeline
Lead Process Specialist - Radiopharmaceuticals
Eli Lilly
11.2025 - Current
Expert Production Technician
Eli Lilly
01.2025 - 11.2025
Filling Lead
Simtra Biopharmaceuticals
04.2023 - 01.2025
Prep Operator
Baxter Pharmaceuticals
01.2022 - 04.2023
Assembler
Cook Medical
05.2021 - 12.2021
CMfgE -
Indiana University Northwest
Bachelor of Music -
Indiana University