Manufacturing Associate/Senior Associate - Drug Product - Advanced Therapies

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.

Organization Overview:

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.

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply. 

This is an exciting opportunity to help start up a state-of-the-art facility and build a manufacturing supply chain from ground-up.

The Manufacturing Associate will be responsible for performing routine manufacturing activities across GMP manufacturing areas, including: Cell Culture, Downstream Purification, and Fill & Finish at the Lebanon Advanced Therapies, LP2 site.

Initially, the Manufacturing Associate will be responsible for supporting execution of equipment qualification, developing site operations procedures and setting up production areas. During this initial project delivery/startup phase of the project, roles will be fluid and dynamic.  Once the plant is operational, the Manufacturing Associate will be responsible for execution of production activities on their shift under the leadership of the shift supervisor.

As a Manufacturing Associate, your responsibilities will include:

• Lead manufacturing teams working in a cleanroom environment to formulate and fill advanced therapies in a safe and quality manner.
• Leverage problem solving skills to evaluate process & protocol deviations real-time and provide assessments to cross functional process teams.
• Apply independent judgement and discretion to execute equipment commissioning and qualification testing and process validation activities under the guidance of the C&Q/validation leads to deliver fully robotic filling process.
• Conduct and appropriately document production of advanced Therapies via strict adherence to digital manufacturing batch records and affiliated SOPs.
• Adhere to all applicable procedures, cGLP, cGMPs, company policies, and any other quality or regulatory requirements.
• Maintain compliance with cleanroom gowning requirements required for completing specific work in drug substance and drug product.
• Apply critical thinking skills to projects outside the manufacturing area, supporting Lebanon Advanced Therapies Manufacturing long-term drug product goals.
• Investigate deviations and implement corrective actions leveraging the local QMS system .

Minimum Requirements: 

• High School diploma + 5 years of operations experience OR Bachelor''s degree in STEM field

Additional Preferences:

• Direct manufacturing experience with automatic, manual, and semi-automated equipment, following operational procedures.
• Technical problem-solving skills.
• Good communications skills (both oral and written).
• Requires learning and understanding Good Manufacturing Practices and strict adherence to GMP regulations.
• Will be expected to