Drug Product Manufacturing Scientist - Advanced Therapies Manufacturing

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

Responsible for providing technical support for the development, implementation, and execution of compliant manufacturing of gene therapy drug product (initial focus: formulation, media & buffer preparation, drug product filling & packaging, and visual inspection operations; from facility startup through validation and commercial manufacturing).

• Provide technical support for TS/MS activities (tech transfer, process validation, investigation, media & buffer recipe, formulation, filling & packaging, visual inspection)
• Apply scientific principles for gene therapy drug product manufacturing (chemistry, equipment, aseptic processes, container closure systems)
• Address and resolve formulation issues
• Own/steer media and buffer preparation formulations
• Prepare/review/approve technical documents (change controls, regulatory submissions, deviation investigations, validation protocols & summary reports, processing records, process descriptions, annual reports)
• Support/lead TS/MS technical projects to improve startup, process control, yield, product quality and/or productivity; implement technical process changes
• Develop/monitor statistically based real-time process variability/capability metrics
• Support daily manufacturing operations via process knowledge and data analysis
• Serve as technical interface external to the Lebanon site; provide audit support as needed
• Work/lead cross-functional teams; ensure safe working environment

• BS in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or related quantitative field
• 3+ years cGMP manufacturing experience (Operations, Validation, TS/MS, Engineering, or Quality Assurance)
• 3+ years parenteral drug product manufacturing (formulation, tech transfer, visual inspection, statistical trending/analysis, process risk assessment e.g., FMEA)
• Authorized to work in the U.S. full-time;
  Lilly does not sponsor work authorization/visas

• In-depth gene therapy manufacturing knowledge; AAV formulation/media/buffer experience
• Solution filling and/or isolator technology; serialization/packaging experience
• Interpersonal/teamwork, self-management/organization, strong oral/written communication
• Data trending/analysis; complex data problem-solving; cross-functional leadership

• Anticipated wage: $66,000 - $171,600; company bonus eligibility and comprehensive benefits (401(k), medical/dental/vision, flexible benefits, life insurance, time off/leave, well-being benefits).