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). This role supports multiple networks and starts during development, continuing through compliant commercial production, guiding technical analysis, solution development, and cross-functional collaboration to deepen scientific understanding and optimize processes.

Responsibilities

• Collaborate with development teams, 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 external contract manufacturers; drive learning, alignment, and improvement across sites.
• Stay current on external manufacturing trends and innovations related to SDD and amorphous solid dispersions to inform strategies.
• Mentor and coach other technical resources on scientific approaches, technology, and business considerations.
• Achieve site/network-level results for dry products using SDD; influence leadership to drive improvements and resolve issues.
• Partner cross-functionally to commercialize, validate, and improve processes for the dry products network; leverage lab/pilot scale models to inform large-scale understanding.
• Collaborate with manufacturing sites to solve issues, drive long-term technology solutions, and ensure regulatory and Quality compliance and reliability of unit operations.
• Support due diligence activities as needed.
• Share knowledge through technical reports, presentations, and direct interactions.

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.

Skills

• 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, particle technology, and polymer material science.
• Experience with API manufacturing, oral solid dose form manufacturing, project management, and operation of spray dryers and SDD equipment.
• Demonstrated technical leadership and ability to communicate effectively across disciplines.
• Ability to influence and drive synchronization/results; self-starter with strong analytical and problem-solving abilities; capable of managing priorities.
• Proficiency with Matlab, gPROMS or similar process modeling tools.

Education

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

Additional Requirements

• Travel may be required (10-20%).
• Location: greater Indianapolis, IN area; on-site presence required.