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Role Summary
The SDD Advisor provides technical leadership and oversight for drug product manufacturing processes with a focus on spray dried dispersions (SDDโรรดs). The role supports development activities and continuous, compliant manufacturing for commercial production, partnering with multiple sites and cross-functional teams to drive technical value and improvements.
Responsibilities
- Collaborate with development, CM&C, and manufacturing sites to build technical capability in Spray Dried Dispersions for dry oral solid drug products.
- Provide technical leadership for manufacturing process transfers among SDD sites, including potential external contract manufacturers.
- Stay current on external pharmaceutical manufacturing trends and innovations related to SDD and amorphous solid dispersions.
- Mentor and coach other technical resources on scientific, technological, and business approaches.
- Achieve site/network results for Lillyโรรดs dry products and influence leadership to drive improvements and resolve issues.
- Partner cross-functionally to commercialize, validate, and improve processes for the dry products network; leverage lab and pilot-scale models to inform large-scale SDD systems.
- Collaborate with manufacturing sites to solve current issues and work on long-term technology solutions, driving optimization, regulatory compliance, and reliability of unit operations.
- Support due diligence activities as needed.
- Share knowledge through technical reports, presentations, and direct interactions.
Qualifications
- BS, MS, or PhD in Chemical Engineering or related technical field
- Minimum 7 years of direct experience in support of the development and/or GMP commercial manufacture of Spray Dried Dispersions (SDDโรรดs) as a drug product intermediate
Skills
- Chemical engineering with strong background in pharmaceutical manufacturing support (data analysis, modeling, solvents, Process Safety Management, control strategies, unit operations, Quality and regulatory compliance)
- Knowledge of chemistry, organic chemistry, physical properties of solids for pharmaceutical processing, particle technology, and polymer material science
- Proficiency in Matlab, gPROMS or similar process modeling tools
- Strong technical leadership and demonstrated ability to influence and drive results
- Excellent written and oral communication across diverse audiences
- Ability to work independently and manage priorities
Education
- BS, MS, or PhD in Chemical Engineering or related technical field
Additional Requirements
- Travel may be required (10-20%)
- Positions located in the greater Indianapolis, IN area; on-site presence required