Lilly is 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. 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.
Requirements
- Direct manufacturing experience with automatic, manual, and semi-automated equipment, following operational procedures.
- Technical problem-solving skills.
- Requires learning and understanding Good Manufacturing Practices and strict adherence to GMP regulations.
- Background in robotics and/or engineering
- Ability to work with and learn new digital systems
Responsibilities
- 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.
Other
- High School diploma + 5 years of operations experience OR Bachelor''s degree in STEM field
- Good communications skills (both oral and written).
- Will be expected to adhere to all safety and environmental guidelines and to promote safety and environmental compliance in all areas.
- Good organization skills.
- Ability to demonstrate attention to detail
