Senior Advisor, Drug Substance Process Development
Eli Lilly and Company
August 22, 2026
On-site
Watertown, MA
Operations
Position Summary
Senior Advisor to design, execute, and oversee experiments for technical development and scale-up of drug substance processes.
Responsibilities
- Lead process development activities for circular RNA manufacturing supporting pre-clinical and clinical studies
- Identify critical process parameters and evaluate scale-up strategies
- Design and perform process development experiments using scientifically sound methodology (including design-of-experiments)
- Partner with supply chain, quality, and CMC to manufacture test article(s) and clinical trial material for preclinical studies
- Generate, interpret, and present data to cross-functional R&D teams
- Collaborate with external vendor SMEs to align oRNA process transfer and development efforts with program timelines and objectives
- Contribute to authoring regulatory documentation and provide input to regulatory interactions
Basic Requirements
- PhD/MS/BS in chemical engineering, biomedical engineering, chemistry, biology, or related field; with relevant industry experience: PhD 6+ years, MS 9+ years, BS 12+ years
- Experience developing biotechnology manufacturing processes, including downstream biomanufacturing technologies
- Experience in a matrixed CMC environment (supply chain, analytical development, formulation development)
- Experience authoring/reviewing development sections for regulatory submissions; strong knowledge of regulatory requirements
Additional Preferences
- Organized and collaborative; able to work with diverse scientists and engineers
- Ability to work on cross-functional teams in a fast-paced, dynamic environment
- Detail oriented, self-motivated, excited to take on new challenges
Benefits (if applicable)
- Company bonus for full-time equivalent employees (depending on company/individual performance)
- Comprehensive benefit program including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits
Senior Advisor to design, execute, and oversee experiments for technical development and scale-up of drug substance processes.
Responsibilities
- Lead process development activities for circular RNA manufacturing supporting pre-clinical and clinical studies
- Identify critical process parameters and evaluate scale-up strategies
- Design and perform process development experiments using scientifically sound methodology (including design-of-experiments)
- Partner with supply chain, quality, and CMC to manufacture test article(s) and clinical trial material for preclinical studies
- Generate, interpret, and present data to cross-functional R&D teams
- Collaborate with external vendor SMEs to align oRNA process transfer and development efforts with program timelines and objectives
- Contribute to authoring regulatory documentation and provide input to regulatory interactions
Basic Requirements
- PhD/MS/BS in chemical engineering, biomedical engineering, chemistry, biology, or related field; with relevant industry experience: PhD 6+ years, MS 9+ years, BS 12+ years
- Experience developing biotechnology manufacturing processes, including downstream biomanufacturing technologies
- Experience in a matrixed CMC environment (supply chain, analytical development, formulation development)
- Experience authoring/reviewing development sections for regulatory submissions; strong knowledge of regulatory requirements
Additional Preferences
- Organized and collaborative; able to work with diverse scientists and engineers
- Ability to work on cross-functional teams in a fast-paced, dynamic environment
- Detail oriented, self-motivated, excited to take on new challenges
Benefits (if applicable)
- Company bonus for full-time equivalent employees (depending on company/individual performance)
- Comprehensive benefit program including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits