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Manufacturing Operations Specialist

2 months ago


Lebanon, Indiana, United States Eli Lilly Full time
About Eli Lilly

Eli Lilly is a global healthcare leader that unites innovation with discovery to make life better for people around the world.

About the Role

This is a unique opportunity to be part of the team for the startup of a greenfield manufacturing site. As a Technical Services/Manufacturing Scientist, you will help design, commission, and start up the facility for both clinical and commercial supply. You will be responsible for providing technical support for the development, implementation, and execution of compliant manufacturing of gene therapy drug product.

Key Responsibilities
  • Provide technical support for all start-up activities of parenteral drug product, including filling & packaging, tech transfer, process validation, media & buffer recipe, and formulation.
  • Understand the scientific principles required for manufacturing gene therapy drug products, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
  • Ensure that accurate instruction sets (tickets & procedures) and Process Flow Diagrams describe the process as performed and the control strategy for the discrete manufacturing steps.
  • Prepare, review, approve, and provide technical support for relevant technical documents, such as change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, process description documents, and annual reports.
  • Participate in development and implementation of process improvements.
  • Work within cross-functional teams to implement technical objectives and deliver on business plan and quality objectives.
  • Develop, monitor, and react to established statistically based metrics in real-time to assess process variability and capability.
  • Apply manufacturing process knowledge and data analysis skills to support the management of daily manufacturing operations.
  • Serve as technical interface external to the site.
  • Provide inspection support, as needed.
  • Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.
Requirements
  • BS or MS in Engineering, Biochemical Engineering, Biochemistry, or related quantitative field.
  • 3 years of experience in cGMP manufacturing, specifically within Operations, Validation, Technical Services, Engineering, or Quality Assurance.
  • Must have experience with parenteral drug product manufacturing.
Preferred Qualifications
  • In-depth knowledge of gene therapy drug product manufacturing.
  • Experience using solution filling equipment and/or isolator technology.
  • Experience with serialization and packaging.
  • Experience with AAV drug product formulation, media, and buffer preparation.
  • Strong interpersonal and teamwork skills.
  • Strong self-management and organizational skills.
  • Strong oral and written communication skills.
  • Experience with data trending and analysis.
  • Ability to analyze complex data and solve problems.
  • Demonstrated successful membership/leadership of cross-functional teams.