Bioprocess Scientist (Drug Product) – Advanced Therapies Manufacturing Full-time

Drug Product Bioprocess Scientist – Technical Services/Manufacturing Scientist (TS/MS)

Lilly recently opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and 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 design, commission and start up the facility for both clinical and commercial supply.

This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.

Position Description:

The Drug Product Bioprocess Scientist – Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support for the development, implementation, and execution of compliant manufacturing of gene therapy drug product. The scope of the role will initially focus on formulation, media & buffer preparation, Drug Product Filling & packaging and visual inspection operations, from facility startup through support of validation processes and commercial manufacturing.

Key Objectives/Deliverables

• Provide technical support for internal and external TS/MS activities (e.g., tech transfer, process validation, investigation, media & buffer recipe, formulation, filling & packaging and visual inspection)
• Understand the scientific principles required for manufacturing gene therapy drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems
• Responsible for ensuring that formulation issues are addressed and resolved
• Ownership and technical stewardship of media and buffer preparation formulations
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, process description documents and annual reports.
• 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.
• Develop, monitor, and appropriately 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 Lebanon site.
• 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

Basic Requirements:

• BS in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry or related quantitative field
• 3+ years of experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS, Engineering, or Quality Assurance.
• 3+ years experience with parenteral drug product manufacturing, particularly with formulation, technical transfer, visual inspection, statistical data trending and analysis and process risk assessment (e.g. FMEA).

Additional Preferences:

• In depth knowledge of gene therapy drug product manufacturing
• Experience with AAV drug product formulation, media and buffer preparation will be a plus
• Experience using solution filling equipment and/or isolator technology
• Experience with serialization and packaging
• 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
• Experience with data trending and analysis
• Ability to analyze complex data and solve problems
• Demonstrated successful membership/leadership of cross-functional teams