Lead Bioprocess Scientist
1 week ago
Eli Lilly is a global leader in healthcare, dedicated to enhancing the quality of life for individuals worldwide. Our headquarters is located in Indianapolis, Indiana, where our employees are committed to discovering and delivering transformative medicines, improving disease management, and contributing to our communities through philanthropy and volunteer initiatives.
At Eli Lilly, we prioritize our workforce and strive to attract individuals who are passionate about making a positive impact on global health.
Position Overview:We are in the process of establishing a state-of-the-art facility for the production of innovative modalities, including Gene Therapy. This facility will represent our most advanced manufacturing site, focusing on the delivery of groundbreaking products.
Equipped with next-generation manufacturing technologies and sophisticated data analysis platforms, this site aims to enhance safety, quality, and operational performance.
This role presents a unique opportunity to contribute to the startup of a greenfield manufacturing site, where the successful candidate will play a crucial role in the design, commissioning, and initiation of both clinical and commercial production.
Key Responsibilities:- Provide technical expertise in the development, implementation, and transfer of compliant manufacturing processes for gene therapy drug substances and products.
- Develop a deep understanding of the scientific principles governing AAV and gene therapy products, including cell culture and bioreactor operations.
- Support all start-up activities related to Technical Services/Manufacturing, including technology transfer and process validation.
- Ensure that manufacturing processes are controlled, capable, compliant, and maintained in a validated state through continuous monitoring.
- Identify opportunities for process improvements and engage in Lean manufacturing initiatives.
- Prepare and review technical documentation, including change controls and validation protocols.
- Lead and support technical projects aimed at enhancing process control, yield, and product quality.
- Collaborate with cross-functional teams to align scientific and operational objectives.
- Promote a safe working environment by adhering to safety regulations and fostering a culture of safety.
- Bachelor's degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, or a related field.
- A minimum of 3 years of experience in cGMP manufacturing, particularly in Operations, Validation, or Engineering.
- Extensive knowledge of gene therapy manufacturing processes.
- Experience with AAV vector purification and cell line platforms.
- Strong analytical skills and the ability to interpret complex data.
- Excellent communication and teamwork abilities.
Join us at Eli Lilly and be part of a team that is dedicated to making a difference in the lives of people around the world.
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