Gene Therapy Drug Product Scientist for Advanced Therapies

712 Lly Lebanon Adv Therapies; Lebanon (IN); On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

401(k)

Health benefits

Paid time off

Job summary

Lilly in Lebanon, Indiana is seeking a qualified candidate to support gene therapy drug product operations through tech transfer, process validation, and handling formulation development. You will contribute to manufacturing of clinical and commercial supplies with a focus on aseptic fill-finish, packaging, and stability.

The role demands strong cGMP experience, collaboration with cross-functional teams, and ability to manage technical documents and change controls.

Qualifications

• B.S. in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry or related quantitative field.
• 3+ years of experience with parenteral or sterile drug product manufacturing, specifically in formulation, aseptic fill-finish, visual inspection, or packaging operations.
• 3+ years of experience in cGMP manufacturing within Operations, Validation, TS/MS, MSAT, Engineering, or Quality Assurance, with exposure to drug product unit operations.

Responsibilities

• Provide technical support for internal and external TS/MS activities specific to drug product operations (e.g., tech transfer, process validation, investigation, drug product formulation buffer/excipient recipe development, filling & packaging, and visual inspection)
• Understand the scientific principles required for manufacturing gene therapy drug products, including interaction of chemistry, equipment, aseptic processes, and container closure systems
• Responsible for ensuring formulation issues in the final drug product are addressed and resolved
• Ownership and technical stewardship of drug product formulation buffer and excipient preparation
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents (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 react to established statistically based metrics in real-time to assess process variability and capability
• Apply manufacturing process knowledge and data analysis to support daily manufacturing operations
• Serve as technical interface external to the Lebanon site
• Provide audit support, as needed
• Work within or lead cross-functional teams 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

Skills

Gene therapy knowledge

Statistical data analysis

Cross-functional teamwork

Strong communication

Education

B.S. in Chemical Engineering or related

Tools

Solution filling equipment

Isolator technology

Serialization

Job description

Lilly in Lebanon, Indiana is seeking a qualified candidate to support gene therapy drug product operations through tech transfer, process validation, and handling formulation development. You will contribute to manufacturing of clinical and commercial supplies with a focus on aseptic fill-finish, packaging, and stability.

The role demands strong cGMP experience, collaboration with cross-functional teams, and ability to manage technical documents and change controls.