Principal SDD Representative

Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

The Principal SDD Representative is expected to provide technical leadership and oversight for drug product manufacturing processes with a focus on spray dried dispersions (SDD’s). This position may support our Engineering Technical Center (ETC), API External Manufacturing (EM), or our Technical Service/Manufacturing Sciences (TS/MS) small molecule network. Responsibilities start during development and continue throughout the reliable and compliant manufacturing processes for commercial production.

This individual will bring key expertise, technical leadership and knowledge to add business value and influence manufacturing decision making. They will lead technical analysis, solution development through personal expertise, laboratory experimental efforts, and direct interactions with manufacturing sites and functional areas. They will support the continuous deepening of scientific understanding of process chemical and physical transformations, engineering principles, and equipment capabilities.

• Collaborate with development (e.g. Small Molecule Design and Development), CM&C, and manufacturing sites to build technical capability and expertise in Spray Dried Dispersions, including manufacturing equipment and process related knowledge, for use in dry oral solid drug products.
• Provide technical leadership and support/guidance for manufacturing process technical transfers among SDD manufacturing sites, potentially including external contract manufacturers. Drive appropriate shared learning, alignment and improvement across sites according to best practices and technical principles.
• Remain current on external pharmaceutical manufacturing trends and innovations related to use and manufacture of SDD and amorphous solid dispersions prepared by evaporation techniques to improve strategies and applications for controlling these processes.
• Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors.
• Achieve site and/or network level results for Lilly’s dry products (oral solid dosage forms using SDD) that improve the business. Influence global leadership to drive improvements and resolve issues.
• Partner cross-functionally (TS/MS, Quality, Engineering, Operations, and Regulatory) to commercialize, validate, and improve processes for the dry products manufacturing network and drive continuous platform improvements as necessary. Partner with Development in leveraging lab scale models and pilot scale to drive understanding and knowledge of large scale SDD systems.
• Collaborate with manufacturing sites to solve current manufacturing issues and work on long-term technology solutions, leading and supporting efforts to drive optimization, regulatory and Quality compliance, and reliability of unit operations.
• Support Due Diligence activities of the corporation as needed.
• Provide knowledge sharing through technical reports, presentations and direct interactions.

• B.S. in Chemical Engineering or related technical field
• Minimum 3 years of experience in support of the development or GMP commercial manufacture of Spray Dried Dispersions (SDD’s) as a drug product intermediate

• Chemical Engineer with strong background in pharmaceutical manufacturing support (data analysis, modeling, working with solvents, exposure to Process Safety Management, understanding the development and use of control strategies, unit operations, Quality and regulatory compliance and regulatory submissions, etc)
• Knowledgeable in chemistry,…