Bioprocess Scientist (Downstream) - Advanced Therapies Manufacturing

About the role

Lilly is seeking a Technical Services/Manufacturing Scientist (TS/MS) to join the team at its cutting-edge manufacturing facility in Lebanon, Indiana. This role involves providing technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance for clinical and commercial manufacture.

Responsibilities

• Build deep technical expertise in your area of responsibility (including in-depth knowledge of the science behind the molecule and the process)
• Have strong working skills on the manufacturing equipment set and control systems
• Demonstrate strong data-driven decision-making and problem-solving capabilities
• Ensure the process is in-control, capable, compliant, and maintained in a validated state through continual monitoring
• Play a role in implementing new technologies and process improvements in the manufacturing environment
• Assess whether the process is in control and capable of meeting its stated purpose and is in a constant state of validation
• Identify process improvements and participate in implementation of Lean manufacturing initiatives
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents
• Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity
• Implement process changes and improvements through the technical agenda
• Monitor and appropriately react to established statistically based metrics in real-time to assess process variability and capability
• Provide audit support, as needed
• Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities

Requirements

• Bachelor's degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, or related quantitative field
• 3+ years of experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS, or Engineering

Additional Preferences

• In-depth knowledge of gene therapy manufacturing
• Experience with large-scale AAV vector production using single-use bioreactor systems
• Experience using solution filling equipment and/or isolator technology
• Experience with QC assays in line with product CQAs including variability
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills
• Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
• Ability to analyze complex data and solve problems
• Demonstrated successful membership/leadership of cross-functional teams