Principal SDD Representative

Role Summary

The Principal SDD Representative provides technical leadership and oversight for drug product manufacturing processes with a focus on spray dried dispersions (SDD’s). This role supports development and continues through commercial production, guiding technical analysis, solution development, and cross-functional collaboration to improve manufacturing capabilities and ensure compliance.

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 and support for manufacturing process transfers among SDD sites, including potential external contract manufacturers; drive learning, alignment, and continuous improvement across sites.
• Stay current on external manufacturing trends and innovations related to SDD and amorphous solid dispersions to inform strategies and process controls.
• Mentor and coach other technical resources in scientific methods, technology, and business approaches.
• Achieve site/network results for Lilly’s dry products using SDD and influence leadership to drive improvements and issue resolution.
• Partner across TS/MS, Quality, Engineering, Operations, Regulatory to commercialize, validate, and improve processes for the dry products network; leverage lab/pilot scale work to inform large-scale understanding.
• Collaborate with manufacturing sites to solve current issues and develop long-term technology solutions, driving optimization, regulatory compliance, and unit operation reliability.
• Support due diligence activities as needed and share knowledge through technical reports and presentations.

Qualifications

• Basic: B.S. in Chemical Engineering or related technical field; minimum 3 years of experience supporting development or GMP commercial manufacture of Spray Dried Dispersions as a drug product intermediate.
• Additional Skills/Preferences: Chemical engineer with strong background in pharmaceutical manufacturing support (data analysis, modeling, solvents, Process Safety Management, control strategies, unit operations, quality and regulatory compliance). Knowledge in chemistry, organic chemistry, physical properties of solids, particle technology, and polymer material science. PE preferred but not required. Experience in API manufacturing, oral solid dose form manufacturing, project management, spray dryer design/operation. Demonstrated technical leadership and strong communication skills. Proficiency with Matlab, gPROMS or similar process modeling tools. Ability to work independently and manage priorities.

Skills

• Technical leadership and cross-functional collaboration
• Process transfer and scale-up
• Data analysis, modeling, and process understanding
• Regulatory and Quality compliance awareness
• Strong written and oral communication across diverse audiences
• Problem-solving and prioritization capabilities

Education

• B.S. in Chemical Engineering or related technical field

Additional Requirements

• Travel may be required (10-20%)
• On-site presence in the greater Indianapolis, IN area