Kilo Lab Technician
Eli Lilly and Company
Summary
The Lilly Medicine Foundry Kilo Lab Technician actively supports start-up activities to bring manufacturing equipment into service. The Technician becomes an expert in their assigned area and supports the team on the proper operation of the facility. This role requires domestic and international travel to collaborate, train, and learn from sites that currently produce APIs. Upon completion of the project phase, the Technician provides on-the-floor support for production of API molecules, ensuring a safety-first, quality-always approach while executing a production process that encompasses diverse unit operations and manufacturing skills.
Job description
Responsibilities
The Kilo Lab Technician will be an integral part of executing the transfer of chemical processes from development laboratories to kiloscale operations, supporting clinical supply activities across multiple modalities including small molecules, peptides, oligonucleotides, and high-potent compounds. Technicians will support daily Kilo Lab activities to meet production plans by:
- Adhering to compliance requirements (safety, quality, and environmental) and appropriately escalating any adverse events.
- Operating processes and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions to meet the production schedule.
- Conducting lab or pilot plant experiments, maintaining notebooks or records, and supplying written summaries to supervisors as needed.
- Accurately dispensing materials as requested and executing written and verbal directions, including material testing, complex experimental designs, and/or process scaling up to pilot plant level.
- Ensuring completion of daily monitoring, testing, and cleaning duties to keep equipment and systems in good operating condition per local and corporate regulatory requirements.
- Assembling and disassembling machinery for processing of materials, demonstrating strong mechanical aptitude.
- Serving as a cultural contributor to site safety culture, promoting compliant operations and positive safety behaviors.
- Supporting troubleshooting and reaction to process upsets, integrating operator input and escalating as appropriate.
- Following all applicable procedures for safety event reporting and documentation, including spill response, issue escalation, and initiating Emergency Response procedures as needed.
- Ensuring adequate communication at shift changeovers and participating in daily shift huddles/meetings to understand and set expectations for daily operational goals.
- Ensuring all area personnel follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.
- Summarizing, preparing, and tabulating data; coordinating activities with other laboratories and support groups.
- Making interpretations of data generated and suggesting subsequent experimentation; offering ways to improve efficiency of time utilization, equipment design, configurations, and process improvements.
- Planning own work schedule and operating with minimal supervision; level of independence increases with experience and equipment familiarity.
- Actively participating in assigned building and area operations such as safety audits, procedure coordination, housekeeping, and continuous improvement projects.
- Understanding and utilizing computer systems and programs for development project activities, including control or automation systems such as Delta V and Pi.
- Using specified company-supplied personal protective equipment (PPE) (e.g., hair and beard coverings, lab coats or gowns, safety shoes, safety glasses, hard hats, etc.) as required.
- Performing clean room gowning and wearing respirators and safety equipment during processing and cleaning of equipment/rooms.
Requirements
- High School Diploma or GED required.
- 3+ years of direct manufacturing experience; GMP and/or chemical processing strongly preferred.
- Demonstrated learning agility to operate a variety of new equipment and systems.
- Strong mechanical aptitude and experience working with solvents and large equipment.
- Demonstrated experience in manufacturing, cGMP, or a regulated environment.
- Qualified applicants must be authorized to work in the United States on a full-time basis.
- Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B, TN, or similar) for this position.
- Previous experience in facility or area start-up environments.
- Prior work in pharmaceutical or chemical manufacturing involving Process Safety Management regulations or hazardous chemicals.
- Previous experience operating kiloscale glassware and equipment such as glass reactor systems, filtration equipment (AFDs, Nutsche filters, cartridge), rotary evaporators, and pumping systems.
- Ability to work cross-functionally with PTE scientists, process engineers, operations, analytical chemists, safety and quality representatives.
- Experience in small molecule, peptide/oligonucleotide, or high-potent manufacturing operations.
- Familiarity with unit operations regarding distillation, filtration, extraction, and chromatography.
- Solid understanding of FDA guidelines and cGMP requirements.
- Demonstrated strong documentation skills.
- Knowledge of lean manufacturing principles.
- Problem-solving skills: proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges.
- Ability to understand technical nomenclature and language and work with mathematical formulas.
- Strong organizational skills with the ability to handle and prioritize multiple projects and requests.
- Demonstrated ability to manage priorities and ambiguity.
- Demonstrated initiative to solve problems, troubleshoot issues, and learn new processes and computer system applications.
- Ability to effectively communicate (electronically, written, and verbal) across levels and functions.
- Basic computer skills required; proficiency in MS Word, Excel, and PowerPoint preferred.
- Working knowledge of synthetic chemistry.
- Post-secondary education helpful.
- Highly motivated, able to learn rapidly, and demonstrates strong attention to detail.
- Strong teamwork and interpersonal skills.
- For internal Lilly employees - LRL/Product Research Development experience preferred.
Benefits
- 401(k)
- Pension
- Vacation benefits
- Medical, Dental & Vision
- Prescription drug benefits
- Flexible spending accounts
- Life insurance
- Death benefits
- Employee assistance program
- Fitness benefits
- Employee clubs and activities
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.