SDD - Advisor

Overview

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The SDD Advisor is expected to provide technical leadership and oversight for drug product manufacturing processes with a focus on spray dried dispersions (SDD). 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.

• 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 (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, organic chemistry, physical properties of solids for pharmaceutical processing, particle technology, and polymer material science
• PE desired, but not required.
• Relevant industrial experience in the following disciplines: API manufacturing, oral solid dose form manufacturing, project management, development, design and operation of spray dryers and related SDD equipment
• Demonstrated, strong technical leadership
• Effective written and oral communication skills across varying disciplines and types of audiences (internal and external)
• Ability to influence and drive synchronization/results
• Knowledge of Matlab, gPROMS and other tools to model and characterize process systems
• Ability to work independently and, as such, must be a self-starter and capable of working with little direction
• Demonstrated, strong analytical and problem-solving abilities
• Capable of managing priorities

• Travel may be required (10-20%)
• Positions located in the greater Indianapolis, IN area
• This is not a remote role and requires on-site presence
• Job title may vary

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