Advisor Engineer, Drug Product and Spray Drying Process Development - SMDD

About the role

The Synthetic Molecule Design and Development (SMDD) department within Lilly Research Labs is involved in key activities for the advancement of small molecules, peptides, and oligonucleotides from early discovery phases to commercialization. Our scientists and engineers develop innovative technical and business solutions across a portfolio of projects using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development.

Responsibilities

• Apply engineering fundamentals to design, scale up, and optimize amorphous solid dispersion (ASD) manufacturing processes, such as spray drying, hot melt extrusion, and/or coprecipitation, for producing drug product intermediates from lab and pilot scale through commercial manufacturing scale.
• Drive process development activities for drug product intermediates advancing toward commercialization, translating process and analytical understanding into a robust, scalable control strategy that supports commercial manufacturing readiness and regulatory filing.
• Support technology transfer and scale-up of manufacturing processes to internal and external sites.
• Collaborate and communicate project specific challenges and opportunities with key partners, including external contract manufacturing organizations, to plan and manage short- and long-term development activities aligned with the global CMC strategy.
• Engage and influence internal and external scientific communities to solve technical challenges, identify and implement novel drug product manufacturing technologies, and inform process and control strategy decisions.
• Author and review high quality technical reports, peer reviewed publications, and regulatory documentation to support new technologies and regulatory submissions.

Requirements

• Ph.D. in Chemical Engineering or a closely related field with 0-5 years of demonstrated experience in pharmaceutical process development, or
• M.S. in Chemical Engineering with 7+ years of demonstrated experience in pharmaceutical process development, or
• B.S. in Chemical Engineering with 10+ years of demonstrated experience in pharmaceutical process development.

Additional Skills/Preferences

• Experience with process development and scale-up of particle engineering and/or amorphous solids manufacturing technologies (e.g., spray drying process, hot melt extrusion, co-precipitation, etc.).
• Experience in technical considerations for equipment design and integration, process monitoring, integration of process analytical technology (PAT) systems, and scientific approaches to control strategy.
• Involvement with process modelling and simulation programs for improved process and formulation understanding.
• Experience with technology transfer to external manufacturing partners and cross-site process comparability.
• Experience supervising or guiding the work of other engineers or scientists.
• Excellent oral communication and documentation skills.
• Demonstrate ability to effectively collaborate with multidisciplinary teams.
• Demonstrate leadership behaviors with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainty.